Clinical Study Start-Up Associate

Rapport Therapeutics; Boston (MA); Presencial; USD 90 000 - 110 000; Tempo integral

Resumo da oferta

Rapport Therapeutics, based in Boston, MA, is seeking a Study Start-Up Associate to join the Clinical Operations team onsite 3 days a week. You will drive study activation by coordinating start-up activities, maintaining critical documentation, and partnering with cross-functional teams to keep studies on track.

The role requires 3+ years in clinical trial start-up, familiarity with ICH-GCP, and experience with TMFs. Expect a fast-paced environment with close collaboration across departments.

Qualificações

• Bachelor’s degree in Life Sciences, Healthcare, or a related field.
• 3+ years of experience supporting clinical trials in biotech/pharma/CRO with start-up experience.
• Experience supporting global, multi-center trials across multiple countries/regions.
• Working knowledge of ICH-GCP guidelines and start-up processes.
• Experience reviewing, tracking, and maintaining essential study documents and TMFs.
• Familiarity with CTMS, eTMF, and document management systems.
• Strong organizational and project coordination skills with ability to manage multiple studies.
• Excellent attention to detail and ability to identify/document gaps.
• Strong written and verbal communication; collaboration across teams, CROs, and study sites.
• Proficiency in Microsoft Office (Excel, Word, PowerPoint, Outlook).
• Self-motivated, proactive, and able to work independently.

Responsabilidades

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

Conhecimentos

Project coordination

Cross-functional collaboration

Attention to detail

Organizational skills

Communication

Formação académica

Bachelor’s degree in Life Sciences, Healthcare, or related field

Ferramentas

CTMS

eTMF

Document management systems

Descrição da oferta de emprego

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 in primary generalized tonic-clonic seizures (PGTCS) 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!

Your impact:

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.

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.

Must-Haves:

• 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! Show up as you are and make every day count.

Your impact:

We get it. Compensation is an important part of your offer. You shouldn’t be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this? We tell you about our hiring range now - we expect the hiring range for this role to be $90,000-$110,000. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don’t stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company.

Hybrid work environment:

This role is onsite in our Boston office. We prioritize in person connection with our fellow Rapptors! Our team members come together onsite at our Boston office Monday, Tuesday and Wednesday to create more opportunities for innovation, collaboration, and connection.

Rapport Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

CCPA disclosure notice can be found here.