Clinical Operations Assistant
Therapeutics Inc.
Summary
This position is in the clinical development and operations function located at our R&D site in San Diego, CA and will report to the head of Clinical Operations. The Clinical Operations Assistant will assist in the implementation and conduct of clinical research projects and provide support for project teams. The position requires acquiring knowledge (through internal training) of clinical trial processes and experience in many aspects of trial execution from study start-up to close-out. This position is onsite full-time.
Job description
Job Summary
This position is in the clinical development and operations function located at our R&D site in San Diego, CA and will report to the head of Clinical Operations. The Clinical Operations Assistant will assist in the implementation and conduct of clinical research projects and provide support for project teams. The position requires acquiring knowledge (through internal training) of clinical trial processes and experience in many aspects of trial execution from study start-up to close-out. This position is onsite full-time.
Key Responsibilities
- Support aspects of multicenter oncology clinical trials, ensuring that studies are carried out in accordance with the protocol, ICH GCP, and local regulatory requirements.
- Develop and maintain study tools including trackers, spreadsheets, and filing systems for various studies.
- Add essential documents and maintain TMF/eTMF in compliance with SOPs, ICH-GCP, TMF plans, and work instructions.
- Perform ongoing reviews and reconciliation activities of trial TMF/eTMF, and follow-up on QA/QC findings, to assure quality and compliance with relevant SOPs and ICH-GCP.
- Track study progress and maintain study status updates (e.g., site selection, IRB approvals, regulatory document collection, enrollment, SDV status, study drug inventory, clinical specimen tracking).
- Help manage study team member training and documentation.
- Support key study-related activities and deliverables.
- Participate in Clinical Operations department initiatives and other duties as assigned.
Qualifications
- Bachelor's degree required. Fresh college graduates with good GPAs and work experience are encouraged to apply.
- Ability to work well with global, multi-disciplinary teams.
- Must be able to thrive in an entrepreneurial, fast paced, and dynamic work environment.
- Must be organized with excellent oral and written communication skills.
- Strong learning orientation, curiosity, and passion for science and patients.
Requirements
- Bachelor's degree required
- Fresh college graduates with good GPAs and work experience encouraged to apply
- Ability to work well with global, multi-disciplinary teams
- Must be able to thrive in an entrepreneurial, fast paced, and dynamic work environment
- Must be organized with excellent oral and written communication skills
- Strong learning orientation, curiosity, and passion for science and patients
Benefits
- Bonus Opportunities
- Stock Options
- 401(k) Matching
- Career Growth Opportunities
- Medical, Dental & Vision
- Vacation & Sick Leave
- 18 Paid Company Holidays
- On-Site Gym
- Complimentary EV Charging
- Flexible Spending Accounts
- Health Savings Accounts
- Life & AD&D Insurance
- Short & Long-Term Disability
- Employee Assistance Program
- Pet Insurance
- Auto & Home Insurance
- Commuter Benefits
- Legal Plans
Company overview
Therapeutics Inc. is a specialized dermatology Contract Research Organization (CRO) founded in June 1997 by Dr. Dan Piacquadio. Based in San Diego, California, the company focuses exclusively on dermatology product development, serving the needs of biotechnology, pharmaceutical, and investment communities. Therapeutics Inc. provides comprehensive development programs for FDA registration of topical, oral, and injectable drugs, biologics, and medical devices. The company's expertise spans from concept to commercialization, designing and managing Phase 1-4 dermatology studies while supporting commercial success through regulatory strategy, market dynamics, competitive intelligence, and product lifecycle management. With a team of seasoned professionals led by Dr. Piacquadio as President and CEO, Therapeutics Inc. combines clinical research experience, medical product development expertise, and dermatology practice knowledge to deliver exceptional development solutions. The company collaborates closely with clients to set realistic goals and deadlines, executing development programs that move products from concept to regulatory approval and market success.