clinical research monitor

Polaris Pharmaceuticals Inc.

<div>
 
 
 Clinical Research Associate
 
 
 
 
 
 
 
 Location : San Diego, CA (Hybrid 1 day/week)
 
 
 
 
 Reports to : Associate Director Clinical Trial Management
 
 
 
 
 Job Type : Full Time
 
 
 
 
 FLSA : Exempt
 
 
 
 
 
 
 
 Company Overview
 
 
 
 Polaris Pharmaceuticals, part of Polaris Group, is a multinational biotechnology company focused on the discovery, development, and manufacturing of innovative therapies, with a primary focus on oncology. The company&rsquo;s lead therapeutic candidate, pegargiminase (ADI-PEG 20), is currently in late-stage clinical development across multiple cancer indications.
 
 
 Polaris operates across the full drug development lifecycle, from research and clinical development to cGMP manufacturing. With facilities in the United States and Asia, the company combines scientific innovation with integrated development and manufacturing capabilities to advance therapies for patients worldwide.
 
 
 
 
 
 
 Job Summary
 
 
 
 We are seeking an in-house Clinical Research Associate with oncology experience to independently monitor and manage clinical sites participating in studies with pegargiminase. No travel requirements are anticipated as all monitoring visits will be conducted remotely. Additional responsibilities will include support for the maintenance of monitoring related documents and trackers.
 
 
 
 
 
 The position will report to the Associate Director Clinical Trial Management and will be hybrid position requiring a minimum of one day per week in the San Diego office.
 
 
 
 
 
 We operate in a fast-paced, dynamic environment where employees are expected to be adaptable, flexible, and willing to take on additional responsibilities as required.
 
 
 
 
 
 
 Key Responsibilities
 
 
 
 
 
 <ul>
 <li>
 Support study monitoring startup tasks including the development of plans and manuals, training, reviewing, and approving essential documents, facilitating completion of clinical study agreements and shipment of investigation product.
 </li>
 <li>
 Perform clinical monitoring activities to ensure that the clinical studies are conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures, Good Clinical Practice, and applicable regulatory requirements
 </li>
 <li>
 Independently conduct monitoring visits to ensure accuracy of data entry with source documentation and perform study drug accountability or manage outsourced CRA performing these activities
 </li>
 <li>
 Review clinical site regulatory documents to ensure completeness and retrieve documents for the Trial Master File
 </li>
 <li>
 Maintain the internal Trial Master File and periodically review
 </li>
 <li>
 Support the preparation of project and study-related documents, including informed consent forms, monitoring plans, synopses, protocol and protocol amendments, and clinical summaries as required
 </li>
 <li>
 Monitor and track clinical research progress and provide status update reports
 </li>
 <li>
 Liaise with clinical sites and provide guidance on site/study issues
 </li>
 </ul>
 
 
 
 
 
 Required Qualifications
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree, preferably in science or healthcare
 </li>
 <li>
 Demonstrated clinical research experience with a minimum of 2 years monitoring experience in the biotech/medical diagnostics/pharmaceutical industry, CRO, or in a hospital setting with experience in oncology
 </li>
 <li>
 Good knowledge of applicable clinical research regulatory requirements including Good Clinical Practice and International Conference on Harmonization guidelines
 </li>
 <li>
 Excellent written and verbal communication skills
 </li>
 <li>
 Computer skills including proficiency in the use of Microsoft Word, Excel and PowerPoint
 </li>
 <li>
 Ability to work independently and prioritize multiple projects in a fast-paced environment.
 </li>
 </ul>
 
 
 
 
 
 Physical / Work Environment
 
 
 <ul>
 <li>
 This role is mainly a desk role requiring proper ergonomics.
 </li>
 </ul>
 
 
 
 
 
 Salary Range
 
 
 <ul>
 <li>
 Annual base salary: $80,000 to $110,000
 </li>
 </ul>
 
 
 
 
 
 Equal Employment Opportunity Statement
 
 
 
 Polaris Pharmaceuticals is an Equal Opportunity Employer. We are committed to building a diverse and inclusive workplace and do not discriminate on the basis of race, color, religion, sex, gender identity or expression, sexual orientation, national origin, age, disability, veteran status, or any other protected characteristic under applicable federal, state, or local laws.
 
 
 
</div>

Clinical Research Associate

IQVIA

<div>
 
 
 IQVIA Biotech is now hiring for CRA 2 with a minimum of 1 year of on-site monitoring and will also consider CRA 1 candidates with a minimum of 6 months on-site monitoring experience. Must have experience monitoring in oncology solid tumor.
 
 
 
 
 
 IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience, we offer agile, therapeutically aligned solutions and trusted partnerships that help bring breakthrough treatments to patients faster.
 
 
 
 
 Job Overview
 
 
 
 We are seeking a dedicated Clinical Research Associate (CRA) to join our team and play a key role in ensuring the successful execution of clinical trials. In this position, you will be responsible for monitoring and managing clinical sites to ensure compliance with study protocols, regulatory requirements, and sponsor expectations. Your work will directly contribute to the integrity and quality of clinical research data.
 
 
 
 Key Responsibilities
 
 
 
 <ul>
 <li>
 Conduct all types of site visits&mdash;selection, initiation, monitoring, and close-out in alignment with the contracted scope of work, Good Clinical Practice (GCP), and ICH guidelines.
 </li>
 <li>
 Collaborate with site staff to implement and track subject recruitment strategies that align with project timelines and enrollment goals.
 </li>
 <li>
 Deliver protocol and study-specific training to site personnel and maintain consistent communication to manage expectations and resolve issues.
 </li>
 <li>
 Assess site performance and adherence to the protocol, escalating quality concerns as needed to ensure compliance and data integrity.
 </li>
 <li>
 Monitor study progress by tracking regulatory submissions, subject enrollment, case report form (CRF) completion, and resolution of data queries.
 </li>
 <li>
 Ensure that essential documents are collected and maintained in both the Trial Master File (TMF) and the Investigator Site File (ISF) in accordance with regulatory standards.
 </li>
 <li>
 Document site management activities, visit outcomes, and follow-up actions through detailed reports and correspondence.
 </li>
 <li>
 Work closely with cross-functional project teams to support study execution and ensure alignment with project goals.
 </li>
 <li>
 Depending on the project, you may also support site-level recruitment planning and financial management, including invoice collection and budget tracking.
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in life sciences or health-related field (or equivalent experience).
 </li>
 <li>
 Requires at least 1 year of on-site monitoring experience.
 </li>
 <li>
 Strong understanding of GCP, ICH guidelines, and regulatory requirements.
 </li>
 <li>
 Ability to travel as required by the project.
 
 
 </li>
 </ul>
 IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
 
 
 IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
 
 
 IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
 
 
 The potential base pay range for this role, when annualized, is $71,900.00 - $169,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
</div>

Clinical Research Associate, IQVIA Biotech

Thermo Fisher Scientific

<div>Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
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

Neuralink

<div>
 
 
 About Neuralink:
 
 
 
 We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans interact with their digital world.
 
 
 
 Team Description:
 
 
 
 The Neuralink Clinical team is at the heart of an ecosystem that merges neuroscience, engineering, and medicine. We work to shape the future of brain-computer interface (BCI) technology through the planning, launch, and execution of groundbreaking human clinical trials. Our team is built on a foundation of excellence, aiming to uphold the highest standards of Good Clinical Practice (GCP) while redefining what&rsquo;s possible and revolutionizing the way people interact with technology. Through strict compliance with ethical and regulatory protocols, we focus on ensuring the well-being of our trial participants while advancing the frontiers of neuroscience! Every day will bring fresh challenges and unprecedented opportunities to pioneer new approaches in the pursuit of our mission. From navigating regulatory pathways, designing trial protocols and documentation, and executing clinical trials, our team is instrumental in translating Neuralink&rsquo;s BCI technology for use in people!
 
 
 
 Job Description and Responsibilities:
 
 
 
 As a Clinical Research Associate, you'll play a crucial role in pioneering groundbreaking clinical studies. Your work will directly contribute to the planning, execution, and success of innovative trials, from the initial phases of study setup to hands-on clinical monitoring and site management. You'll be visiting sites both in-person and remotely to ensure protocol and regulatory compliance, tackle safety event management, and maintain essential documentation. Collaborating closely with a passionate, cross-functional team, as well as external partners, you'll be at the forefront of Neuralink's mission to push the boundaries of what&rsquo;s possible in clinical research. Additional job responsibilities will include:
 
 
 <ul>
 <li>
 Conduct site initiation, interim monitoring, and close-out visits (remote and on-site)
 </li>
 <li>
 Ensure clinical studies are conducted in accordance with protocol, GCP, ISO 14155, and applicable regulatory requirements (e.g., 21 CFR Part 812)
 </li>
 <li>
 Verify the accuracy, completeness, and consistency of clinical trial data through source data verification (SDV) and source data review (SDR)
 </li>
 <li>
 Monitor participant safety by reviewing adverse events (AEs), serious adverse events (SAEs), and device deficiencies for completeness and timeliness
 </li>
 <li>
 Ensure sites maintain adequate regulatory documentation, including Investigator Site Files (ISF), informed consent forms, and essential documents
 </li>
 <li>
 Track site performance, enrollment, and data quality metrics; proactively identify risks and implement mitigation strategies
 </li>
 <li>
 Support site training on protocol, investigational device use, and study procedures
 </li>
 <li>
 Collaborate cross-functionally with Clinical Operations, Data Management, Regulatory, and Quality teams
 </li>
 <li>
 Ensure timely resolution of data queries and protocol deviations
 </li>
 <li>
 Prepare and maintain monitoring reports and follow-up letters in accordance with timelines
 </li>
 <li>
 Support audit and inspection readiness at the site level
 </li>
 </ul>
 
 
 Required Qualifications:
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in life sciences, engineering, or related field
 </li>
 <li>
 5+ years of clinical research experience (device experience strongly preferred)
 </li>
 <li>
 Working knowledge of GCP (ICH E6), ISO 14155, and applicable FDA regulations
 </li>
 <li>
 Experience with electronic data capture (EDC) systems and clinical trial documentation
 </li>
 <li>
 Strong understanding of clinical trial processes, including monitoring and site management
 </li>
 <li>
 Excellent communication, organization, and problem-solving skills
 </li>
 <li>
 Ability to work independently in a fast-paced, evolving environment
 </li>
 <li>
 Up to 30% travel (domestic and occasional international)
 </li>
 </ul>
 
 
 Preferred Qualifications:
 
 
 
 
 
 <ul>
 <li>
 Experience in neuromodulation, implantable devices, or other Class III medical devices
 </li>
 <li>
 Experience supporting IDE or PMA clinical studies
 </li>
 <li>
 Familiarity with risk-based monitoring approaches
 </li>
 <li>
 Exposure to early feasibility or first-in-human studies
 </li>
 <li>
 Exposure to market approval studies
 </li>
 <li>
 Willingness and ability to travel up to 30&ndash;50% (domestic and occasional international)
 </li>
 </ul>
 
 Expected Compensation:The anticipated base salary for this position is expected to be within the following range. Your actual base pay will be determined by your job-related skills, experience, and relevant education or training. We also believe in aligning our employees&rsquo; success with the company's long-term growth. As such, in addition to base salary, Neuralink offers equity compensation (in the form of Restricted Stock Units (RSU)) for all full-time employees.
 
 
 Base Salary Range:: $89,000 USD - $148,000 USD
 
 
 
 What We Offer:
 
 
 
 Full-time employees are eligible for the following benefits listed below.
 
 <ul>
 <li>
 An opportunity to change the world and work with some of the smartest and most talented experts from different fields
 </li>
 <li>
 Growth potential; we rapidly advance team members who have an outsized impact
 </li>
 <li>
 Excellent medical, dental, and vision insurance through a PPO plan
 </li>
 <li>
 Paid holidays
 </li>
 <li>
 Commuter benefits
 </li>
 <li>
 Meals provided
 </li>
 <li>
 Equity (RSUs)
 
 *Temporary Employees &amp; Interns excluded
 
 </li>
 <li>
 401(k) plan
 
 *Interns initially excluded until they work 1,000 hours
 
 </li>
 <li>
 Parental leave
 
 *Temporary Employees &amp; Interns excluded
 
 </li>
 <li>
 Flexible time off
 
 *Temporary Employees &amp; Interns excluded
 
 </li>
 </ul>
</div>

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
 
 
 
 
 These positions are field based / remote in the following locations: CA, WA, OR, IA, MN, IN, OH, FL. Candidates must reside in one of the these states and be willing to travel for site visits.
 
 
 
 
 Purpose
 
 
 
 Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging new advanced capabilities to drive industry leading performance.
 
 
 Partners with the investigator and site staff for meaningful and effective engagements positioning AbbVie as the 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
 
 
 
 <ul>
 <li>
 Considered as the primary point of contact for the investigative site. High level of competency or experience in providing contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie&rsquo;s positioning.
 </li>
 <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.
 </li>
 <li>
 Conducts site evaluation, site training, routine, 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>
 Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.
 </li>
 <li>
 Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate 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 experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development. May participate 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.
 </li>
 <li>
 Advanced 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>
 Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. 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>
 
 Qualifications
 
 
 
 
 Qualifications
 
 
 
 <ul>
 <li>
 Education: Bachelor&rsquo;s degree or equivalent degree; health related preferred (e.g. Medical, Scientific, Nursing, Pharmacy).
 </li>
 <li>
 Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials. Familiar with risk&hyphen;based monitoring approach, onsite and offsite monitoring.
 </li>
 <li>
 Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
 </li>
 <li>
 Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
 </li>
 <li>
 Demonstrate strong cross-functional collaboration skills among internal and external stakeholders.
 </li>
 <li>
 Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
 </li>
 <li>
 Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.
 </li>
 <li>
 Strong 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 use functional expertise with appropriate guidance, 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 atthe time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors includinggeographic location, 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 aparticular 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.
 
 
 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>

Clinical Research Associate II - Oncology (Remote US - Multiple Openings)

<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.
Must be legally authorized to work in the United States without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.
This is a functional service provider (FSP) Clinical Research Associate (CRA) opportunity, you will be dedicated to one sponsor, monitoring seven days a month, 50% onsite and 50% remotely based on business needs. This position is targeted to travel regionally, travel can be national if needed. Ideal candidates will have one to two years of onsite pharmaceutical CRA experience.
Discover Impactful Work
Performs and coordinates all 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. 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.
A Day in the Life<ul><li>
Monitors investigator sites with a risk-based monitoring approach: applies root Functions 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 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>
Keys to Success
Education and Experience
Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
Valid driver's license where applicable.
CRA Level II
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1+ years as a clinical research monitor).
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, Abilities<ul><li>
Proven clinical monitoring skills, ideal candidates will have monitoring experience with oncology, HIV, respiratory and or vaccine/flu</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-depth investigation 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 flexible 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>
Work Environment:
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:<ul><li>
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.</li><li>
Able to work upright and stationary for typical working hours.</li><li>
Ability to use and learn standard office equipment and technology with proficiency.</li><li>
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.</li></ul>
Compensation and Benefits
The salary range estimated for this position based in Washington is $66,800.00&ndash;$112,938.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:<ul><li>
A choice of national medical and dental plans, and a national vision plan, including health incentive programs</li><li>
Employee assistance and family support programs, including commuter benefits and tuition reimbursement</li><li>
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy</li><li>
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan</li><li>
Employees&rsquo; Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount</li></ul>
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards</div>

Clinical Research Associate (Level II) - FSP Vaccines - West Region

<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 
This positions is field based / remote in Southern CA. Candidates must reside in Southern California and be willing to travel for site visits.
Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging new advanced capabilities to drive industry leading performance. 
Partners with the investigator and site staff for meaningful and effective engagements positioning AbbVie as the 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<ul><li>
Considered as the primary point of contact for the investigative site. High level of competency or experience in providing contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie&rsquo;s positioning.</li><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.</li><li>
Conducts site evaluation, site training, routine, 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>
Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.</li><li>
Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate 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 experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development. 
May participate 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.</li><li>
Advanced 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>
Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. 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> 

Qualifications 
<ul><li>
Education: Bachelor&rsquo;s degree or equivalent degree; health related preferred (e.g. Medical, Scientific, Nursing, Pharmacy).</li><li>
Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials. Familiar with risk‐based monitoring approach, onsite and offsite monitoring.</li><li>
Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.</li><li>
Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.</li><li>
Demonstrate strong cross-functional collaboration skills among internal and external stakeholders.</li><li>
Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.</li><li>
Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.</li><li>
Strong 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 use functional expertise with appropriate guidance, 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 atthe time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors includinggeographic location, 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 aparticular 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>

Clinical Research Associate II - Southern CA

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