clinical research monitor

Everest Clinical Research

<div>Everest Clinical Research (&ldquo;Everest&rdquo;) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest&rsquo;s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.

Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients&rsquo; needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength&hellip;that&rsquo;s us&hellip;that&rsquo;s Everest.

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as a Senior Clinical Research Associate (Pain/Oncology/CNS Therapeutic Areas).

Key Accountabilities:
<div>
<ul><li>Interact with personnel from study Sponsors, investigational sites, vendors, and Everest functional groups to enable quality and on-time execution of clinical trials in compliance with ICH-GCP and relevant local regulations.</li></ul>
<ul><li>Identify potential sites for participation in clinical trials.</li></ul>
<ul><li>Perform protocol/site feasibility and Pre-Study Visits to recommend qualified sites.</li></ul>
<ul><li>Participate in Investigator Meetings, Clinical Research Associate (CRA) and Study Coordinator training sessions, and assist sites with study-related questions as needed.</li></ul>
<ul><li>Provide feedback to study manuals, Case Report Form completion guidelines, monitoring plans, informed consents, recruitment materials, and monitoring tools, as needed.</li></ul>
<ul><li>Perform Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits in compliance with the approved protocol and monitoring plan.</li></ul>
<ul><li>Submit quality and on-time Monitoring Visit Reports and follow-up letters to the Clinical Operations Lead or designee for review and approval via Clinical Trial Management System (CTMS).</li></ul>
<ul><li>Complete monitoring visit reports and follow-up letters, including summaries of the significant findings, deviations, deficiencies, and recommended actions to ensure site compliance.</li></ul>
<ul><li>Assist with oversight visits and monitoring visit report review/approval of CRA I/II, evaluating their performance and providing feedback to their supervisor, if requested.</li></ul>
<ul><li>Review ISFs to ensure essential documents are current and submitted to the TMF throughout the trial for reconciliation purposes. Ensure sites have submitted relevant documents to their Institutional Review Board/Ethics Committee as needed. The CRA is responsible for ensuring that the TMF is maintained in an inspection-ready state.</li></ul>
<ul><li>Establish regular lines of communication and administer ongoing protocol/study-related training to assigned sites.</li></ul>
<ul><li>Assist with site management tasks and ensure continuous data flow (i.e., on-time site data entry, query resolution, and source document verification). Assess the clinical research site&rsquo;s patient recruitment/retention success and offer suggestions for improvement.</li></ul>
<ul><li>Ensure proper handling, accountability, and reconciliation of all investigational products, medical devices, and clinical trial supplies.</li></ul>
<ul><li>Prepare sites for inspections/audits conducted either by regulatory authorities, Sponsors, or Contract Research Organizations.</li></ul>
<ul><li>Submit accurate and on-time expense reports.</li></ul>
<ul><li>Assist with preparation of materials for Requests for Proposals and bid defenses.</li></ul>
<ul><li>Assist the Clinical Operations team with additional related tasks as needed.</li></ul>
<ul><li>Plan and carry out professional development.</li></ul>
<ul><li>Complete timesheets as requested and on-time.</li></ul>
</div>
Qualifications and Experience:
<div>
<ul><li>Bachelor&rsquo;s degree in a Life Science or related field of study.</li></ul>
<ul><li>Minimum of 4 years&rsquo; of relevant and/or monitoring experience.</li></ul>
<ul><li>Thorough knowledge of ICH-GCP guidelines and applicable regulations.</li></ul>
<ul><li>Demonstrated experience working on clinical trials across Pain (acute and chronic), Oncology, and CNS therapeutic areas.</li></ul>
<ul><li>Thorough comprehension of medical terminology.</li></ul>
<ul><li>Excellent organization and communication skills (both verbal and written).</li></ul>
<ul><li>Ability to travel a maximum of 70% of working hours to locations nationwide. Less travel hours may apply for projects with remote/virtual visits.</li></ul>
<ul><li>Must maintain a valid driver&rsquo;s license and be able to drive to monitor sites.</li></ul>
</div>
To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.ecrscorp.com

Estimated Salary Range: $ 125,000 - 145,000.

We thank all interested applicants, however, only those selected for an interview will be contacted.

Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.</div>

Senior Clinical Research Associate (Pain/Oncology/CNS Therapeutic Areas)

Thermo Fisher Scientific

<div>Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
At Thermo Fisher Scientific, you&rsquo;ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on &ndash; now and in the future.
Our global Clinical Operations colleagues within our PPD&reg; clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.
Our Clinical Operations team is searching for an experienced CRA (all levels)!<h2 class="jobSectionHeader">
Position Overview:</h2>
Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.<h2 class="jobSectionHeader">
Essential Functions:</h2><ul><li>
Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.</li><li>
Participates in investigator meetings as necessary. May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.</li><li>
Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.</li><li>
Provides trial status tracking and progress update reports to the team as required. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System).</li><li>
Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections.</li><li>
Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner.</li><li>
Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. Contributes to other project work and initiatives for process improvement, as required.</li></ul><h1 class="jobSectionHeader">
Keys to Success:</h1><h2 class="jobSectionHeader">
Education and Experience:</h2><ul><li>
Bachelor's degree in a life science-related field</li><li>
Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years independent on-site monitoring experience as clinical research monitor) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered.</li><li>
Proven understanding of ICH-GCP, EU and FDA requirements</li><li>
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology</li><li>
Outstanding communication, collaboration, organisational and time management skills</li><li>
Fluent in English and Turkish</li><li>
Valid driver's license where applicable</li></ul>
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.<h2 class="jobSectionHeader">
Knowledge, Skills, Abilities</h2><ul><li>
Basic medical/therapeutic area knowledge and understanding of medical terminology</li><li>
Ability to attain and maintain a working knowledge of ICH GCPs and applicable regulations and procedural documents</li><li>
Good oral and written communication skills, with the ability to communicate effectively with medical personnel</li><li>
Good interpersonal skills</li><li>
Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers&rsquo; underlying issues</li><li>
Good organizational and time management skills</li><li>
Ability to remain flexible and adaptable in a wide range of scenarios</li><li>
Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving</li><li>
Ability to manage Risk Based Monitoring concepts and processes</li><li>
Ability to work in a team or independently as required</li><li>
Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software</li><li>
Good English language and grammar skills</li><li>
Must be based in T&uuml;rkiye.</li></ul><h2 class="jobSectionHeader">
Why Join Us?</h2>
We hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore you will benefit from an award-winning learning and development programme, ensuring you reach your potential.<h2 class="jobSectionHeader">
What We Offer:</h2>
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD&reg; clinical research services truly value a work-life balance. We&rsquo;ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.</div>

Clinical Research Associate (CRA) - All Levels

<div>
 
 Work Schedule
 
 
 
 Standard (Mon-Fri)
 
 
 
 Environmental Conditions
 
 
 
 Office
 
 
 Join Us as a Clinical Research Associate (Level II) &ndash; Make an Impact at the Forefront of Innovation
 
 
 We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
 
 
 As part of our global team, you&rsquo;ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.
 
 
 What You&rsquo;ll Do:
 
 
 <ul>
 <li>
 Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
 </li>
 <li>
 Participates in investigator meetings as necessary. Identifies potential
 </li>
 <li>
 investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
 </li>
 <li>
 Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
 </li>
 <li>
 Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
 </li>
 <li>
 Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
 </li>
 <li>
 Responds to company, client and applicable regulatory requirements/audits/inspections.
 </li>
 <li>
 Maintains &amp; completes administrative tasks such as expense reports and timesheets in a timely manner.
 </li>
 <li>
 Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
 </li>
 <li>
 Contributes to other project work and initiatives for process improvement, as required.
 
 
 </li>
 </ul>
 Education and Experience Requirements:
 
 
 <ul>
 <li>
 Bachelor's degree in a life sciences related fieldor a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
 </li>
 <li>
 Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship.
 </li>
 <li>
 Valid driver's license where applicable.
 
 
 </li>
 </ul>
 In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
 
 
 Knowledge, Skills and Abilities:
 
 
 <ul>
 <li>
 Proven clinical monitoring skills
 </li>
 <li>
 Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
 </li>
 <li>
 Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
 </li>
 <li>
 Well-developed critical thinking skills, including but not limited to: critical mindset, in-depthinvestigation for appropriate root cause analysis and problem solving
 </li>
 <li>
 Ability to manage Risk Based Monitoring concepts and processes
 </li>
 <li>
 Good oral and written communication skills, with the ability to communicate effectively with medical personnel
 </li>
 <li>
 Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers&rsquo; underlying issues
 </li>
 <li>
 Good organizational and time management skills
 </li>
 <li>
 Effective interpersonal skills
 </li>
 <li>
 Attention to detail
 </li>
 <li>
 Ability to remain flexibile and adaptable in a wide range of scenarios
 </li>
 <li>
 Ability to work in a team or independently as required
 </li>
 <li>
 Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
 </li>
 <li>
 Good English language and grammar skills
 </li>
 <li>
 Good presentation skills
 
 
 </li>
 </ul>
 Working Conditions and Environment:
 
 
 <ul>
 <li>
 Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.
 </li>
 <li>
 Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays.
 </li>
 <li>
 Exposure to biological fluids with potential exposure to infectious organisms.
 </li>
 <li>
 Personal protective equipment required such as protective eyewear, garments and gloves.
 </li>
 <li>
 Exposure to fluctuating and/or extreme temperatures on rare occasions
 
 
 </li>
 </ul>
</div>

CRA II

AbbVie

<div>Company Description 
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. 
Job Description 
Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging advanced capabilities to drive industry leading performance. 
Partners with study teams, AbbVie internal R&amp;D stakeholders, investigators, and site staff for meaningful and effective engagements positioning AbbVie as the partner of choice in clinical trials. 
Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.
Responsibilities:
Considered as the Primary Sponsor Point of contact for the investigative site. Advanced level of competency or experience in providing contextual information on the clinical trials, connecting stakeholders to the investigative sites and strengthening Abbvie's positioning. Ability to motivate and align monitoring community through leadership and mentorship.<ul><li>
Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol, and patient treatment principles for the trial ensuring a trusted partnership. Able to support, guide, and mentor junior personnel on Site Management activities.</li><li>
Conducts site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.</li><li>
Superior understanding of site engagement and ability to customize site engagement strategy for assigned study/ies and critically apply new strategies as needed. Gather local/site insights and utilize site engagement tools to report/track progress and measure impact of that strategy.</li><li>
Superior level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Expert understanding to generate and ensure effective recruitment and retention techniques/plans based on the patient disease journey. Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.</li><li>
Possesses advanced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development. Supports local onboarding of more junior CRAs. Demonstrates ability to openly listen to and consider viewpoints to enhance outcomes.</li><li>
May participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by manager.</li><li>
Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues. Superior ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.</li><li>
Independently Identifies, evaluates and recommends new/potential investigators/sites on an on going basis demonstrating expert understanding and decision making. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.</li><li>
Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. Ensures audit and regulatory inspection readiness at assigned clinical site at all times. Manages investigator payments as per executed contract obligations, as applicable.</li></ul><ul><li> 
This is a remote position. Candidates must be based in MA and be willing to travel for site visits.</li></ul> 
Qualifications 
<ul><li>
Education: Bachelor&rsquo;s degree or equivalent degree; health related preferred (e.g. Medical, Scientific, Nursing, Pharmacy).</li><li>
Minimum of 3 years of clinically related experience, of which a period of 2 years is preferable in independent clinical research monitoring of investigational drug or device trials in any therapeutic area. Familiar with risk‐based monitoring approach, onsite and offsite monitoring.</li><li>
Knowledge of appropriate therapeutic area indications with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials</li><li>
Superior knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.</li><li>
Demonstrate advanced communication skills and superior cross-functional collaboration skills among internal and external stakeholders.</li><li>
Demonstrate superior planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.</li><li>
Superior ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.</li><li>
Superior interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.</li><li>
Ability to independently use functional expertise, leverage critical thinking skills and apply good judgement to address clinical site issues</li><li>
Acts with integrity in accordance with AbbVie code of business conduct and leadership values. Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.</li></ul> 

Additional Information 
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
<ul><li>The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at thetime of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographiclocation, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
</li><li>We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
</li><li>This job is eligible to participate in our short-term incentive programs.
</li></ul>Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company&rsquo;s sole and absolute discretion, consistent with applicable law.<div></div>
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US &amp; Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html</div>

Senior Clinical Research Associate

ImmunityBio, Inc.

<div>
 
 Company Overview
 
 
 
 ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient&rsquo;s natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient&rsquo;s immune system and treat the host rather than just the disease.
 
 
 Why ImmunityBio?
 
 
 <ul>
 <li>
 ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
 </li>
 <li>
 Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.
 </li>
 <li>
 Work with a collaborative team with the ability to work across different areas of the company.
 </li>
 <li>
 Ability to join a growing company with professional development opportunities.
 
 
 </li>
 </ul>
 
 Position Summary
 
 
 
 The Clinical Research Associate I will participate in clinical research teams to ensure the most effective and efficient conduct of clinical research studies by providing training, protocol interpretation, document collection and review and overall clinical trial support.
 
 
 
 Essential Functions
 
 
 
 <ul>
 <li>
 Develop, review, and update study-related training materials and documents including site initiation training slides, informed consent form templates, procedures manuals, laboratory and pharmacy manuals
 </li>
 <li>
 Interpret medical and scientific intent of assigned study protocols and study procedures, logistics, risks to research subjects and safety, data evaluation methods etc.
 </li>
 <li>
 Communicate scientific rationale for assigned studies to team members and clinical sites
 </li>
 <li>
 Serve as Subject Matter Expert for clinical sites including providing guidance on protocol interpretation and eligibility requirements
 </li>
 <li>
 Create/edit, distribute and collect site feasibility questionnaires
 </li>
 <li>
 Oversee and support collection of essential documents during study start-up
 </li>
 <li>
 Determine materials and other resources needed to conduct the clinical trial and manage their acquisition and distribution.
 </li>
 <li>
 Collect study and site metrics and maintain study trackers, as needed
 </li>
 <li>
 Conduct case report form (CRF) data review and review of source documents, work with sites to resolve data queries
 </li>
 <li>
 Communicate regularly with field Clinical Research Associates (CRAs) to provide information before and after site visits
 </li>
 <li>
 Partner with field CRAs and CTAs to resolve issues identified during site visits
 </li>
 <li>
 Work with Supply Chain to ensure sites maintain sufficient investigational product (IP) to properly conduct the trial as well as resolve IP temperature monitoring excursions and train or assist sites with corrective actions
 </li>
 <li>
 Train vendors, investigators, and study coordinators on study requirements and provide guidance on site issues
 </li>
 <li>
 Conduct clinical specimen log review, and coordinate shipment of specimens to the sponsor or contracted vendor
 </li>
 <li>
 Train sites on specimen and shipment requirements for central laboratory and serve as liaison with contracted vendors
 </li>
 <li>
 Conduct remote monitoring tasks including reconciliation of site investigational product accountability
 </li>
 <li>
 Provide data listings and compile clinical study report documents to support medical writing activities
 </li>
 <li>
 Create and/or review of slides, overheads, etc., for a project, departmental, sponsor and/or business development presentations
 </li>
 <li>
 Provide support and escalate issues to the Clinical Trial Manager (CTM) as appropriate.
 </li>
 <li>
 Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.
 
 
 </li>
 </ul>
 
 Education &amp; Experience
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in a clinical research, science, or health-related field with 2 years of experience in a clinical research setting; or a high school diploma with 3 years of experience in a clinical research setting required
 </li>
 <li>
 2 years of experience as a Clinical Research Coordinator, Clinical Trial Associate or In-House Clinical Research Associate strongly preferred
 
 
 </li>
 </ul>
 
 Knowledge, Skills, &amp; Abilities
 
 
 
 <ul>
 <li>
 Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe
 </li>
 <li>
 Excellent written/oral communication skills
 </li>
 <li>
 Strong organizational and multi-tasking skills
 </li>
 <li>
 Maintain corporate confidentiality at all times
 </li>
 <li>
 Ability to set priorities and independent decision making
 </li>
 <li>
 Ability to work independently as well as in teams
 </li>
 <li>
 Strong oral and written communication skills
 </li>
 <li>
 Outgoing and confident demeanor
 </li>
 <li>
 Independent thinker and persuasive communicator
 </li>
 <li>
 Detail oriented, with solid organization and time management skills
 </li>
 <li>
 Completes projects with reliability and minimal guidance
 </li>
 <li>
 Knowledge of drug development process
 </li>
 <li>
 Computer literacy: EDC, eTMF, CTMS, etc.
 </li>
 <li>
 Working knowledge of ICH E6, and the Code of Federal Regulations
 
 
 </li>
 </ul>
 
 Working Environment / Physical Environment
 
 
 
 <ul>
 <li>
 This position works remotely with ability to work flexible hours for various time zones
 </li>
 <li>
 Must be able to travel up to 75% of the time based on study requirement.
 
 
 </li>
 </ul>
 This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate&rsquo;s qualifications, prior experience as well as geographic location.
 
 
 $103,900 (entry-level qualifications) to $114,300 (highly experienced) annually
 
 
 The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.
 
 
 ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options
 
 
 <ul>
 <li>
 Health and Financial Wellness Programs
 </li>
 <li>
 Employer Assistance Program (EAP)
 </li>
 <li>
 Company Paid and Voluntary Life/AD&amp;D, Short-Term and Long-Term Disability
 </li>
 <li>
 Healthcare and Dependent Care Flexible Spending Accounts
 </li>
 <li>
 401(k) Retirement Plan with Company Match
 </li>
 <li>
 529 Education Savings Program
 </li>
 <li>
 Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
 </li>
 <li>
 Paid Time Off (PTO) includes: 11 Holidays
 </li>
 <li>
 Exempt Employees are eligible for Unlimited PTO
 </li>
 <li>
 Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
 </li>
 <li>
 We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.
 
 
 </li>
 </ul>
 At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.
</div>

Clinical Research Associate I, Field Monitor

Precision for Medicine

<div>**We need a CRA in the Southeast, USA. i.e. GA, FL, NC, SC, etc.

Precision for Medicine is not your typical CRO. We are passionate about supporting professional growth and are proud to share extremely high CRA retention rates compared to industry averages.

CRAs join us, love their jobs, and stay because of the amazing people and enjoyable quality of life. Travel is reasonable and your work/life balance will benefit as a result. Most meaningfully - your voice will be heard. Working in a midsized CRO allows you to have influence and impact when it matters most with support from direct line management.

To support continued growth from our clients, we are hiring all levels of CRAs experienced in monitoring Oncology or Cardiology.

Position Summary:

The CRA II is a seasoned, experienced professional in monitoring and site management. Responsibilities will be dependent upon the type and timing of the program to which the CRA II is assigned and typically include activities involving start-up and study implementation, on-site monitoring of clinical research studies as well as on-going site management. Incumbents work independently as a study team member.

Essential functions of the job include but are not limited to:
<ul>
<li>Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.</li>
<li>Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.</li>
<li>Updates, tracks and maintains study specific trial management tools/systems, and status reports.</li>
<li>If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.</li>
<li>If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.</li>
<li>Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.</li>
<li>Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote).</li>
<li>Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.</li>
<li>Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.</li>
<li>Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.</li>
<li>Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.</li>
<li>Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.</li>
<li>Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies.</li>
<li>Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.</li>
<li>Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.</li>
<li>Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.</li>
<li>Travels as necessary according to project needs.</li>
<li>Performs other duties as assigned by management.</li>
</ul>
Qualifications:

Minimum Required:
<ul><li>4-year college degree or equivalent experience in a scientific or healthcare discipline.</li>
<li>Two (2) years or more as a CRA in a CRO or equivalent, relevant experience and/or demonstrated competencies. Site management or equivalent experience 
in clinical research</li>
</ul>
Other Required:
<ul><li>Excellent communication and organizational skills are essential. A team player.</li>
<li>Evidence of a client focused approach</li>
<li>Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail.</li>
<li>Ability to travel overnight. Up to 60% travel on average, based on regional requirements. International travel as needed.</li>
<li>Fluency in English and for non-English speaking countries the local language of country where position based</li>
</ul>
Preferred:
<ul><li>Graduate or postgraduate degree</li>
<li>Lupus monitoring experience</li>
<li>Experience monitoring in rare and complex therapeutic areas</li>
<li>Experience monitoring EDC trials and EHR records</li>
<li>Experience in biopharma or relevant therapeutic area</li>
<li>Relevant site start-up (feasibility, contract negotiations, submissions) experience for the particular country</li>
<li>Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines.</li>
<li>Ability to resolve project related problems and prioritizes workload to meet deadlines with minimal support from management.</li>
</ul>
Competencies:
<ul><li>Exhibits self-motivation and is able to work and plan independently as well as in a team environment</li>
<li>Understands clinical trials methodology, including a working knowledge of protocols and indications being studied</li>
<li>Demonstrates professionalism as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills</li>
<li>Collects data of consistently high standard</li>
<li>Demonstrated ability to conduct formal presentations to a wide variety of audiences including 
colleagues, investigative staff, and clients with a high level of proficiency</li>
<li>Fluency in English and for non-English speaking countries the local language of country where 
position based</li>
</ul>
About Precision for Medicine

Precision for Medicine is a precision medicine CRO. Precision's uniquely integrated offerings enable the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for complex disease states.

Precision medicine is revolutionizing the attack on cancer. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions&mdash;and optimize the oncology development pathway.

We invite you to learn more about our growing organization serving clients that are researching groundbreaking therapies. We strive to ensure employees feel appreciated through a multitude of benefits including paid time off, volunteer time off, robust medical offerings, non-vested 401k plus company match, paid parental leave and more. At Precision, your ideas and contributions are valued and nurtured, impacting positive change for the company.<div> 
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.</div></div>

Clinical Research Associate II

Precision Medicine Group

<div>**We need a CRA in the Southeast, USA. i.e. GA, FL, NC, SC, etc.

Precision for Medicine is not your typical CRO. We are passionate about supporting professional growth and are proud to share extremely high CRA retention rates compared to industry averages.

CRAs join us, love their jobs, and stay because of the amazing people and enjoyable quality of life. Travel is reasonable and your work/life balance will benefit as a result. Most meaningfully - your voice will be heard. Working in a midsized CRO allows you to have influence and impact when it matters most with support from direct line management.

To support continued growth from our clients, we are hiring all levels of CRAs experienced in monitoring Oncology or Cardiology.

Position Summary:

The CRA II is a seasoned, experienced professional in monitoring and site management. Responsibilities will be dependent upon the type and timing of the program to which the CRA II is assigned and typically include activities involving start-up and study implementation, on-site monitoring of clinical research studies as well as on-going site management. Incumbents work independently as a study team member.

Essential functions of the job include but are not limited to:
<ul>
<li>Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.</li>
<li>Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.</li>
<li>Updates, tracks and maintains study specific trial management tools/systems, and status reports.</li>
<li>If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.</li>
<li>If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.</li>
<li>Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.</li>
<li>Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote).</li>
<li>Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.</li>
<li>Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.</li>
<li>Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.</li>
<li>Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.</li>
<li>Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.</li>
<li>Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies.</li>
<li>Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.</li>
<li>Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.</li>
<li>Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.</li>
<li>Travels as necessary according to project needs.</li>
<li>Performs other duties as assigned by management.</li>
</ul>
Qualifications:

Minimum Required:
<ul><li>4-year college degree or equivalent experience in a scientific or healthcare discipline.</li>
<li>Two (2) years or more as a CRA in a CRO or equivalent, relevant experience and/or demonstrated competencies. Site management or equivalent experience 
in clinical research</li>
</ul>
Other Required:
<ul><li>Excellent communication and organizational skills are essential. A team player.</li>
<li>Evidence of a client focused approach</li>
<li>Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail.</li>
<li>Ability to travel overnight. Up to 60% travel on average, based on regional requirements. International travel as needed.</li>
<li>Fluency in English and for non-English speaking countries the local language of country where position based</li>
</ul>
Preferred:
<ul><li>Graduate or postgraduate degree</li>
<li>Lupus monitoring experience</li>
<li>Experience monitoring in rare and complex therapeutic areas</li>
<li>Experience monitoring EDC trials and EHR records</li>
<li>Experience in biopharma or relevant therapeutic area</li>
<li>Relevant site start-up (feasibility, contract negotiations, submissions) experience for the particular country</li>
<li>Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines.</li>
<li>Ability to resolve project related problems and prioritizes workload to meet deadlines with minimal support from management.</li>
</ul>
Competencies:
<ul><li>Exhibits self-motivation and is able to work and plan independently as well as in a team environment</li>
<li>Understands clinical trials methodology, including a working knowledge of protocols and indications being studied</li>
<li>Demonstrates professionalism as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills</li>
<li>Collects data of consistently high standard</li>
<li>Demonstrated ability to conduct formal presentations to a wide variety of audiences including 
colleagues, investigative staff, and clients with a high level of proficiency</li>
<li>Fluency in English and for non-English speaking countries the local language of country where 
position based</li>
</ul>
About Precision for Medicine

Precision for Medicine is a precision medicine CRO. Precision's uniquely integrated offerings enable the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for complex disease states.

Precision medicine is revolutionizing the attack on cancer. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions&mdash;and optimize the oncology development pathway.

We invite you to learn more about our growing organization serving clients that are researching groundbreaking therapies. We strive to ensure employees feel appreciated through a multitude of benefits including paid time off, volunteer time off, robust medical offerings, non-vested 401k plus company match, paid parental leave and more. At Precision, your ideas and contributions are valued and nurtured, impacting positive change for the company.<div> 

Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.</div></div>

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