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.