Study Startup Specialist
About The Position
The Startup Study Specialist is responsible for the successful initiation of clinical trials by coordinating and executing all study start-up activities across assigned projects within a fast-paced startup environment. This includes managing essential document collection, site activation, regulatory submissions, and ensuring compliance with ICH-GCP, SOPs, and local regulatory requirements. The SSUA ensures that clinical sites are ready to initiate and enroll patients on time, contributing to the overall success of the clinical development program. This requires hybrid work at our Princeton, NJ location.
Requirements
- Bachelor’s degree in Life Sciences, Business, or related field (advanced degree a plus).
- 2+ years in clinical study startup, site activation, or regulatory submissions (startup experience preferred).
- Familiarity with clinical trial platforms.
- Exceptional organizational and project management skills.
- Ability to thrive in ambiguity and pivot quickly.
- Strong negotiation and communication skills (written and verbal).
- Experience in oncology study.
Responsibilities
- Coordinate and oversee all aspects of study start-up activities for assigned clinical trials.
- Prepare and submit regulatory documents (e.g., IRB/EC applications, FDA forms) to ensure timely approvals.
- Track and report startup milestones (e.g., site activation timelines, enrollment targets).
- Support the development of SOPs and templates for scalable study execution.
- Propose solutions to reduce site activation timelines in resource-constrained environments.
- Prepare, review, and submit essential regulatory documents to ethics committees (ECs), institutional review boards (IRBs), and regulatory authorities.
- Track submissions and approvals to ensure study timelines are met.
- Support contract and budget negotiations by liaising with key stakeholders.
- Maintain accurate tracking systems and study documentation and document management systems (eTMF) and ensure audit readiness.
- Communicate regularly with project teams, clinical research associates (CRAs), regulatory affairs, and clinical sites to ensure smooth site activation.
- Contribute to continuous improvement initiatives related to start-up processes and tools.
- Ensure compliance with ICH-GCP guidelines, company SOPs, and local regulations at all times.
- Stay updated on evolving regulations (GCP, GDPR, etc.) and adapt processes accordingly.
Benefits
- SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
11-50 employees
