Clinical Study Start-Up Associate
Rapport Therapeutics
Summary
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.
Job description
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.
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.
Benefits
- Unlimited PTO
- Lifestyle Spending Account
- Commuting Reimbursement
- Competitive Benefits Package
Company overview
Rapport Therapeutics is a biotechnology company focused on developing precision medicines for central nervous system (CNS) disorders. The company specializes in targeting receptor-associated proteins (RAPs) to create novel therapeutics with improved efficacy and safety profiles for neurological and psychiatric conditions. By leveraging its proprietary platform technology, Rapport aims to identify and develop small molecule drugs that modulate specific protein-protein interactions within neural circuits, offering more targeted approaches to treating complex brain disorders. The company's research pipeline includes potential treatments for conditions such as epilepsy, neuropathic pain, and other CNS-related diseases where current therapeutic options remain limited. Rapport Therapeutics represents an innovative approach in the neuroscience field, combining molecular biology expertise with drug discovery capabilities to address unmet medical needs in neurology and psychiatry.