Clinical Trial Associate II

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.

• 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.

• 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.

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.

Pep Gen 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.

Pep Gen is a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. Pep Gen’s Enhanced Delivery Oligonucleotide (EDO) platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are…