Clinical Study Start-Up Associate

Join our Clinical Operations team and play a key role in getting clinical studies off the ground. As a Study Start-Up Associate, you'll help drive study activation by coordinating essential start-up activities, managing critical documentation, and partnering with cross-functional teams to keep studies on track. If you're highly organized, thrive in a fast-paced environment, and enjoy bringing structure to complex projects, this is a great opportunity to make an impact from day one.

• Support study start-up activities from protocol finalization through site activation.
• Coordinate, review, track, and maintain essential study documents (e.g., protocols, ICFs, IBs, regulatory documents, and site activation packages).
• Perform quality checks of study documentation and maintain inspection-ready TMFs in compliance with ICH-GCP and company SOPs.
• Track study start-up milestones, including regulatory submissions, IRB/EC approvals, and site activation status.
• Partner with Clinical Operations, Regulatory, CROs, and vendors to drive timely study start-up and resolve outstanding action items.
• Prepare and maintain study trackers, templates, and other operational documents.
• Support vendor contract administration, purchase orders, and invoice tracking.
• Coordinate study meetings, document meeting minutes, and track follow-up actions.
• Assist with clinical trial registrations, insurance documentation, and other study start-up requirements.
• Provide operational and administrative support to the Clinical Operations team as needed.

• Bachelor's degree in Life Sciences, Healthcare, or a related field.
• 3+ years of experience supporting clinical trials in a biotech, pharmaceutical, or CRO environment, with experience in study start-up required
• Experience supporting global, multi-center clinical trials, including site start-up and activation activities across multiple countries and regions.
• Working knowledge of ICH-GCP guidelines and the clinical trial start-up process.
• Experience reviewing, tracking, and maintaining essential study documents and Trial Master Files (TMFs).
• Familiarity with CTMS, eTMF, and document management systems.
• Strong organizational and project coordination skills with the ability to manage multiple studies and competing priorities in a fast-paced environment.
• Excellent attention to detail and ability to identify and resolve documentation gaps.
• Strong written and verbal communication skills with the ability to collaborate effectively across cross-functional teams, CROs, and study sites.
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, and Outlook).
• Self-motivated, proactive, and able to work independently while contributing to a collaborative team environment.
• Ability to maintain confidentiality and exercise sound judgment when handling sensitive clinical information.

• Every role has meaning. We’re determined to discover a better way for patients, and you’ll feel the passion from the start.
• We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities.
• Your perspective matters. Stick your neck out, share your ideas – we work as a team.
• We have FUN. We hire smart, dedicated, down-to-earth people that you’ll enjoy spending time with.
• Leadership that CARES – about you, your growth + development.
• We're bicoastal. Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston – we make the most of our time together.
• Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!
• You get to be YOU! Show up as you are and make every day count.