Clinical Trial Associate

Description:

Timberlyne Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing transformational therapies for high unmet medical needs. The company's lead program, CM313, is an IgG1 monoclonal antibody that targets CD38, modulating immune cells for durable responses in autoimmune diseases and cancers.

We are seeking a Clinical Trial Associate (CTA) to join our Clinical Operations team. This role is essential in supporting the planning, execution, and management of clinical trials, ensuring compliance with company policies and regulatory requirements.

Key Responsibilities:

✔ Support the Clinical Operations team under the supervision of the Clinical Program Manager
✔ Maintain the Trial Master File (TMF) and ensure documentation compliance
✔ Contact clinical trial sites, vendors, CROs, and partners as needed
✔ Perform administrative tasks related to clinical project management
✔ Prepare and maintain meeting agendas, minutes, and tracking logs
✔ Track clinical trial progress, including enrollment updates and status reports
✔ Assist with study-level documentation, including pharmacy manuals, regulatory binders, and training materials
✔ Coordinate and distribute study-related materials to clinical sites and team members
✔ Schedule internal and external meetings and generate timely meeting minutes
✔ Ensure accurate document collection and preparation for site close-out
✔ Process and track investigator site regulatory documents required by the FDA and other authorities
✔ Oversee clinical supply coordination and shipment tracking
✔ Assist in the quality review of critical documentation (e.g., Informed Consent Forms, regulatory green light packages)
✔ Identify, resolve, and escalate clinical trial issues as needed

Required Skills & Qualifications:

📌 Education: B.S. or B.A. in biological sciences (advanced degree preferred)
📌 Experience: Minimum 2+ years of relevant industry experience
📌 Regulatory Knowledge: Familiarity with FDA, ICH, and GCP regulations and guidelines
📌 Technical Skills: Proficiency in Microsoft Word, Excel, and PowerPoint
📌 Communication: Excellent written and verbal communication skills
📌 Organizational Skills: Strong time management, multitasking, and prioritization abilities
📌 Problem-Solving: Ability to manage unexpected challenges and changing priorities
📌 Adaptability: Comfortable working in a fast-paced, small company environment
📌 Travel: Ability to travel as required

Equal Opportunity Employer:

Timberlyne Therapeutics is committed to fostering a diverse and inclusive work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity/expression, national origin, disability, age, veteran status, or any other legally protected characteristic.