Study Startup Specialist

Responsibilities

• Cook up and oversee all facets of study start-up activities for assigned clinical trials. Draft and submit regulatory documents (e.g., IRB/EC applications, FDA forms) to secure timely approvals.
• Track and report startup milestones (e.g., site activation timelines, enrollment targets).
• Contribute to the development of SOPs and templates for streamlined study execution.
• Propose strategies to expedite site activation timelines in resource-constrained settings.
• Prepare, review, and submit essential regulatory documents to ethics committees (ECs), institutional review boards (IRBs), and regulatory authorities.
• Monitor submissions and approvals to ensure adherence to study timelines.
• Collaborate on contract and budget negotiations by interfacing with key stakeholders.
• Maintain accurate tracking systems and study documentation, ensuring audit readiness.
• Regularly communicate with project teams, CRAs, regulatory affairs, and clinical sites to facilitate smooth site activation.
• Participate in continuous improvement initiatives related to start-up processes and tools.
• Absolutely adhere to ICH-GCP guidelines, company SOPs, and local regulations.
• Stay abreast of evolving regulations (ICH-GCP, GDPR, etc.) and adjust processes accordingly.

Qualifications

• Bachelor’s degree in Life Sciences, Business, or a related field (advanced degree preferred).
• At least 2 years of experience in clinical study startup, site activation, or regulatory submissions (preferred if startup experience).
• Familiarity with clinical trial platforms.
• Exceptional organizational and project management skills.
• Ability to thrive in ambiguous situations and adapt quickly.
• Strong negotiation and communication skills (both written and verbal).
• Experience in oncology studies.

Compensation and Benefits

The expected base salary range for this position is $70,000 - $95,000 annually. Actual compensation will be determined based on a variety of factors, including but not limited to a candidate’s qualifications, experience, and skills. While most offers typically fall within the lower to mid-range of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceed the role’s requirements. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, 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. SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.