clinical trial monitor

RTI LABORATORIES

Job Summary We are seeking a dynamic and detail-oriented Clinical Research Associate (CRA) to join our innovative clinical development team. In this vital role, you will oversee the planning, execution, and monitoring of clinical trials to ensure compliance with regulatory standards and study protocols. Your expertise will drive the successful management of clinical research projects, ensuring data integrity, patient safety, and adherence to all applicable regulations. This position offers an exciting opportunity to contribute to groundbreaking medical advancements while working in a collaborative and fast-paced environment.Responsibilities<ul><li>Coordinate and monitor clinical trials across multiple sites, ensuring adherence to study protocols, FDA regulations, ICH GCP guidelines, and company standards. </li><li>Conduct site qualification visits, initiate visits, routine monitoring visits, and close-out visits to verify compliance and data accuracy. </li><li>Review and verify source documents, case report forms (CRFs), and other trial documentation for completeness and accuracy. </li><li>Provide training and support to site staff on protocol procedures, data collection methods, EMR systems, and regulatory requirements. </li><li>Monitor patient safety by reviewing adverse event reports, ensuring proper documentation, and reporting to relevant authorities as required. </li><li>Manage trial documentation including ethics submissions, informed consent forms, regulatory binders, and audit readiness files. </li><li>Collaborate with cross-functional teams such as clinical operations, data management, laboratory personnel, and medical staff to facilitate smooth trial execution. </li><li>Ensure compliance with HIPAA regulations concerning patient confidentiality and data security. </li><li>Assist in the review of clinical laboratory results, vital signs data, blood sampling procedures (phlebotomy), and other clinical assessments. </li><li>Support statistical analysis activities by coordinating with statisticians using software tools designed for clinical data analysis. </li><li>Maintain detailed records of site communications, monitoring reports, and trial progress for audit purposes.</li></ul>Experience<ul><li>Proven supervising experience in managing clinical trials or overseeing clinical research teams. </li><li>Extensive knowledge of clinical trials management processes from initiation through close-out phases. </li><li>Strong understanding of medical terminology, FDA regulations, ICH GCP guidelines, and CDISC standards for data exchange. </li><li>Hands-on experience with EMR systems and electronic data capture (EDC) platforms for efficient data management. </li><li>Background in nursing or clinical laboratory work (including blood sampling and vital signs measurement) is highly desirable. </li><li>Familiarity with statistical software used in clinical research for data analysis purposes. </li><li>Certification such as ICH GCP certificate from a recognized issuer (including CA) is required; additional certifications in HIPAA compliance or phlebotomy are a plus. </li><li>Excellent analysis skills combined with meticulous attention to detail to ensure high-quality documentation review and compliance management. Join us in advancing medical science through rigorous research practices! We value energetic professionals committed to excellence in clinical development who thrive in collaborative environments dedicated to improving patient outcomes worldwide.</li></ul>Pay: $51,498.23 - $62,019.38 per yearWork Location: In person

Clinical Research Associate

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>

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

ICON plc

<div>Clinical Research Associate
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
As a Senior CRA at ICON Plc, you will oversee and manage clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. Our client is looking for someone with Phase I/II oncology experience.
What You Will Do:
You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement. 
 
Key responsibilities include:<ul><li>
Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.</li><li>
Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.</li><li>
Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.</li><li>
Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.</li><li>
Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.</li></ul>
Your Profile:
You will have a strong foundation in clinical trial monitoring, with the experience to work independently and guide others. 
 
Required qualifications and experience:<ul><li>
Bachelor's degree in a relevant scientific discipline or healthcare-related field</li><li>
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.</li><li>
Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills.</li><li>
Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.</li><li>
Strong Oncology experience monitoring Phase I/II trials.</li><li>
Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.</li><li>
Willingness to travel as required (approximately 60%)</li></ul>
What ICON can offer you:<div><div><div><div>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:<ul><li>
Various annual leave entitlements</li><li>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</li><li>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</li><li>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</li><li>
Life assurance</li><li>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</li></ul></div></div></div></div>
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.<div><div><div><div>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know<div>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</div></div></div></div></div>
Salary Range
$110,520.00-$138,150.00
Bonus, Com, Stock, Benefits &amp; Disclaimer verbiage:
Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level. You may be eligible for a bonus, stock compensation and commissions in some cases depending on your role and performance.</div>

Senior Clinical Research Associate

<div>Clinical Research Associate - California
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
As a CRA at ICON Plc, you will oversee and manage clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards.
What You Will Do:
You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement. 
 
Key responsibilities include:<ul><li>
Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.</li><li>
Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.</li><li>
Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.</li><li>
Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.</li><li>
Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.</li></ul>
Your Profile:
You will have a strong foundation in clinical trial monitoring, with the experience to work independently and guide others. 
 
Required qualifications and experience:<ul><li>
Bachelor's degree in a relevant scientific discipline or healthcare-related field</li><li>
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.</li><li>
Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills.</li><li>
Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.</li><li>
Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.</li><li>
Willingness to travel as required (approximately 60%)</li></ul>
What ICON can offer you:<div><div><div><div>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:<ul><li>
Various annual leave entitlements</li><li>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</li><li>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</li><li>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</li><li>
Life assurance</li><li>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</li></ul></div></div></div></div>
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.<div><div><div><div>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know<div>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</div></div></div></div></div></div>

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>

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

CRA (Level II) - FSP Vaccines - Southeast

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CRA (Level II) - FSP Vaccines - Southeast