Clinical Study Start-Up Associate

Responsibilities

• Your day-to-day:
• 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.

Requirements

• 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.
• What makes Rapport special:
• 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! Sho

Benefits

Additional Information

When our people share why they joined Rapport and love it here, it comes down to three things: the science, the mission, and the team. At Rapport, we're driven by a passion for developing precision neuromedicines with the potential for fewer side effects, enabling patients and their families to enjoy healthier, more fulfilling lives. And we're doing this with extraordinary science and awesome people (affectionately called Rapptors). Our innovative scientific platform is centered on Receptor Associate Proteins (RAPs). RAPs are a component of neuronal receptor complexes, which play a crucial role in regulating receptor assembly and function. This precision approach has the potential to revolutionize the development of small molecule therapies. We are excited about the potential of our lead program, RAP-219. Our first indication targets focal epilepsy with additional clinical trials for neuropathic pain and bipolar disorder. The strength of Rapport comes from our Rapptors - who are united by our mission to improve patients lives. We bring the heart and hustle to advance our science forward, always staying true to our core values. We hope you're as excited about this opportunity as we are! This role is based in Boston, MA and is required to be onsite Monday-Wednesday each week!

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