Study Startup Specialist

Systimmune • Princeton, NJ

3d • $70,000 - $95,000

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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level