The Clinical Trial Associate II will support our experienced, high-performing Clinical Operations team. We are seeking a collaborative, proactive, and adaptable professional with experience in clinical sample management to join us during an exciting period of growth. This role is well-suited for someone who thrives in a fast-paced, small biotech environment and brings a strong, team-oriented mindset.
Responsibilities:
- Manage the lifecycle of the biological samples (biomarkers, PK/PD) from collection kits, site shipment, laboratory vendor coordination, tracking (LIMS), data reconciliation with lab results, and resolving sample-related issues, in collaboration with the Clinical Research Organization (CRO), bioanalytical laboratories and internal Biomarkers team
- Serve as the primary liaison with the bioanalytical team to ensure end-to-end process oversight from sample collection through delivery and long-term storage
- Support the development and distribution of clear, timely communications to both internal and external stakeholders
- Track and maintain critical clinical trial documents, including internal study contact lists and training matrices, informed consent forms and site reference materials
- Manage the submission, tracking, review, and reconciliation of the electronic Trial Master File (TMF) documents in collaboration with the Clinical Project Manager (CPM)
- Review monitoring visit reports (MVRs) and provide comments to CRO
- Proactively identify and resolve issues that could affect the trial’s progress, escalating to appropriate team members when necessary
- Support contract and budget reviews in collaboration with the CPM
- Participate in internal team meetings, including agenda creation, detailed meeting minutes, and regular status updates on project progress and key milestones
Qualifications:- Bachelor’s Degree required
- 2+ years of experience in clinical research at a CRO or other biotech/pharmaceutical company (as a Clinical Trial Associate, Clinical Research Associate, etc.)
- Prior experience with clinical sample management, maintaining the eTMF and reviewing MVRs is strongly preferred
- Prior experience in the pharmaceutical/biotech industry is strongly preferred
- Excellent organizational skills and exceptional attention to detail
- Strong written and verbal communication abilities
- Proficient in Microsoft Office, clinical trial management systems (CTMS), and electronic Trial Master File (TMF) systems
- Ability to prioritize and handle multiple tasks while meeting deadlines
- Team-oriented with excellent interpersonal skills and the ability to foster cross-functional collaboration
- Self-motivated with the ability to work independently and take initiative
- Strong problem-solving and analytical thinking
- Ability to thrive in a dynamic, fast-paced environment with a flexible, can-do attitude
- Demonstrates integrity, honesty, flexibility, and an exceptional work ethic
Compensation
The estimate full-time salary range for this role is between $95,000 to $115,000. The final compensation package offered to a successful candidate will reflect a number of factors including but not limited to prior experience, relevant skills, education, qualifications and certifications, business needs, internal equity, and market data.
PepGen provides eligible employees a comprehensive and competitive total compensation package including but not limited to a discretionary annual bonus, equity, health insurance (including medical, dental, and vision), life and disability insurance, paid time off with paid holidays, paid parental leave, a 401(k) plan, cell phone reimbursement, student loan repayment or 529 contributions, and a lifestyle spending account.
