CV and Credentials Coordinator
CenExel · United States
- Hybrid
- Full-time
- $60,000 / year
- United States
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Job highlights
- Create and maintain CVs for site staff.
- Manage investigator credentialing and documentation.
- Ensure regulatory compliance for clinical trials.
- Support new personnel onboarding.
- Work remotely with competitive benefits.
About the role
About Us
CenExel is a leading nationwide clinical research site and patient network serving the life sciences industry. Leading in CNS and early phase studies, our 18 science-led Centers of Excellence deliver the right patients, at the right time, in the right place. Recently acquired by BayPine Capital Partners, our research sites provide unparalleled medical and scientific support in the design and execution of clinical trials. Our world-class PIs, advanced patient engagement strategies, premium data analytics, and integrated operations optimize every step of the clinical trial process.
Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.
Job Summary
The Clinical Research CV and Credentials Coordinator is responsible for curriculum vitae (CV) creation for all CenExel Site Staff (including contracted staff) and onboarding new Investigators. Managing, verifying, and maintaining up-to-date CVs and credentialing documentation for investigators and research staff. This role ensures compliance with institutional, regulatory, and sponsor requirements, supporting clinical trials and research operations.
Essential Responsibilities And Duties
- Collects, creates, and maintains CVs for investigators and research staff.
- Collects and reviews credentialing documents (licenses, certifications, GCP training, etc.) for investigators and research staff.
- Ensures CVs are current (biennually for research staff and biannually for principal investigators) and formatted appropriately for regulatory submissions.
- Verifies professional licenses and certifications with appropriate boards and agencies.
- Tracks credentialing expiration dates and sends timely reminders for renewal.
- Maintains electronic databases or regulatory systems (e.g., CTMS, eReg) to manage documents and track compliance.
- Collaborates with clinical research coordinators, investigators, and regulatory specialists to ensure documentation completeness and accuracy.
- Assists with audit preparation and responds to documentation-related requests from sponsors, CROs, or regulatory authorities.
- Ensures all documentation meets FDA, ICH-GCP, and sponsor requirements.
- Supports onboarding of new research personnel by gathering initial credentials and ensuring training compliance.
- Regularly reviews and updates site-specific trial lists to include newly awarded studies.
- Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies.
- Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.
Education/Experience/Skills
- Must be able to effectively communicate verbally and in writing.
- Bachelor’s degree in Health Sciences, Life Sciences, Healthcare Administration, or related field preferred.
- 1–3 years of experience in clinical research, credentialing, or regulatory documentation.
- Familiarity with ICH-GCP, FDA, and other regulatory guidelines.
- Proficiency in Microsoft Office Suite (Word, Excel, Outlook) and document management systems.
- Strong attention to detail and organizational skills.
- Ability to handle confidential information with discretion.
- Excellent communication and interpersonal skills.
- Experience with electronic regulatory systems (e.g., RealTime, Florence eBinders).
- Certified Clinical Research Professional (CCRP) or equivalent credential is a plus.
Working Conditions
- Essential physical requirements include sitting, typing, standing, and walking.
- Lightly active position, occasional lifting of up to 20 pounds.
- Reporting to work, as scheduled, is essential.
- Remote work arrangement.
CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.
Key skills/competency
- CV Creation
- Credentialing
- Regulatory Documentation
- Clinical Research
- GCP Training
- FDA Compliance
- ICH-GCP
- Microsoft Office Suite
- Electronic Regulatory Systems
- Audits
Skills & topics
- CV Creation
- Credentialing
- Regulatory Documentation
- Clinical Research Coordinator
- GCP Training
- FDA Compliance
- ICH-GCP
- Regulatory Affairs
- Healthcare Administration
- Remote Job
How to get hired
- Tailor your resume: Highlight clinical research, credentialing, and regulatory documentation experience, emphasizing regulatory guidelines like ICH-GCP and FDA.
- Showcase technical skills: Detail your proficiency in Microsoft Office Suite and experience with electronic regulatory systems (e.g., RealTime, Florence eBinders).
- Emphasize soft skills: Demonstrate strong attention to detail, organizational skills, and excellent communication and interpersonal abilities in your application.
- Understand regulatory compliance: Familiarity with FDA, ICH-GCP, and sponsor requirements is crucial for this CV and Credentials Coordinator role.
- Prepare for remote work: Highlight your ability to work independently and manage confidential information with discretion in a remote setting.
Technical preparation
Behavioral questions
Frequently asked questions
- What is the primary responsibility of the CV and Credentials Coordinator at CenExel?
- The CV and Credentials Coordinator at CenExel is primarily responsible for creating and maintaining CVs for all site staff and investigators, managing their credentialing documentation, and ensuring compliance with all regulatory and sponsor requirements for clinical trials.
- What qualifications are preferred for the CV and Credentials Coordinator position?
- A Bachelor’s degree in Health Sciences, Life Sciences, Healthcare Administration, or a related field is preferred. Additionally, 1-3 years of experience in clinical research, credentialing, or regulatory documentation is desired, along with familiarity with ICH-GCP, FDA, and proficiency in Microsoft Office Suite.
- Is this a remote position, and what are the working conditions for the CV and Credentials Coordinator?
- Yes, this is a remote work arrangement. The role involves essential physical requirements like sitting, typing, standing, and walking, and is considered a lightly active position with occasional lifting of up to 20 pounds.
- What kind of regulatory knowledge is required for the CV and Credentials Coordinator at CenExel?
- The CV and Credentials Coordinator must be familiar with ICH-GCP, FDA, and other relevant regulatory guidelines. They will ensure all documentation meets FDA, ICH-GCP, and sponsor requirements, and adhere to CenExel's standard operating procedures and company policies.
- How does CenExel support its full-time employees in this role?
- CenExel provides highly competitive compensation and a generous benefits package to full-time employees after 30 days of employment, including Health Insurance, Dental, Vision, LTD, STD, Life Insurance, and 401k.
- What electronic systems might a CV and Credentials Coordinator use at CenExel?
- Experience with electronic regulatory systems such as CTMS, eReg, RealTime, or Florence eBinders is beneficial for managing documents and tracking compliance in the CV and Credentials Coordinator role.