Clinical Trials Associate
Therapeutics Inc.
Summary
Reporting to the Director, Clinical Operations, the Clinical Trial Associate is a critical member of the project team responsible for supporting the execution of clinical studies through the coordination and maintenance of study documentation, clinical systems, communications, and operational activities. This role partners closely with Clinical Operations team members to ensure study documentation is complete, accurate, and maintained in accordance with company SOPs, ICH-GCP guidelines, and applicable regulations.
Job description
Responsibilities
- Support clinical studies from study start-up through closeout
- Maintain Trial Master Files (TMF) and support inspection readiness activities
- Assist with collection, filing, reconciliation, and archival of study documentation
- Coordinate study team meetings, agendas, minutes, and action items
- Maintain study trackers, metrics, and operational reports
- Support site communications and document exchange
- Assist with study startup activities, including collection of essential documents
- Support vendor onboarding and administrative study activities
- Maintain training records and associated study documentation
- Assist with audit and inspection preparation
- Support clinical systems utilized by study teams
- Participate in departmental process improvement initiatives
- Develop collaborative relationships with study team members and external partners
- Ensure activities are conducted in accordance with SOPs, regulations, and ICH-GCP guidelines
Qualifications
- BA/BS degree in Health Sciences, Life Sciences, Nursing, or related discipline required
- 0-2 years of experience in Clinical Research, Clinical Operations, Healthcare, or related field
- Basic understanding of clinical research processes and ICH-GCP guidelines preferred
- Strong collaboration, communication, and interpersonal skills
- Reliable, self-motivated, team player
- Strong attention to detail with exceptional organizational skills
- Demonstrated strong written and verbal communication skills
- Ability to prioritize workload and manage multiple assignments
- Ability to work in a fast-paced environment
- Strong commitment to ethical standards
- Proficiency with Microsoft Office Suite (Word, PowerPoint, Excel, Outlook, Teams, SharePoint, etc.)
- Ability to travel up to 10%
Requirements
- BA/BS degree in Health Sciences, Life Sciences, Nursing, or related discipline required
- 0-2 years of experience in Clinical Research, Clinical Operations, Healthcare, or related field
- Basic understanding of clinical research processes and ICH-GCP guidelines preferred
- Strong collaboration, communication, and interpersonal skills
- Reliable, self-motivated, team player
- Strong attention to detail with exceptional organizational skills
- Demonstrated strong written and verbal communication skills
- Ability to prioritize workload and manage multiple assignments
- Ability to work in a fast-paced environment
- Strong commitment to ethical standards
- Proficiency with Microsoft Office Suite (Word, PowerPoint, Excel, Outlook, Teams, SharePoint, etc.)
- Ability to travel up to 10%
Benefits
- Competitive Pay
- Stock Options
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Paid Parental Leave
- Short-Term Disability Coverage
- Long-Term Disability Coverage
- Life Insurance
- Travel Insurance
- AD&D Coverage
- 401(k) Company Match
- Employee Stock Purchase Plan
- Generous Vacation
- Paid Company Holidays
- Fertility Programs
- Mental Health Programs
- Financial Wellness Programs
- Physical Health Programs
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.