In-House Sr. Clinical Research Associate (Contract to Perm)
Therapeutics Inc.
Summary
Anagram Therapeutics is seeking a hands-on, collaborative In-House, Sr. Clinical Research Associate who will provide sponsor side oversight and hands on operational support for global clinical trials. This role is a 6-9 month consultant role with the potential to become a permanent position. This position will focus on site performance, CRO monitoring oversight, site enrollment, data quality/tracking, protocol compliance and timely resolution of operational issues. In a small biotech environment, the successful candidate must be comfortable working independently, identifying risks early, and taking ownership of follow-up through resolution. The role will conduct sponsor oversight, co-monitoring, remote monitoring and targeted site visits as needed to supplement CRO activities and address risks and support enrollment and data completion objectives. Domestic and international travel will be required as needed (estimated up to 30-40% at times based on project need).
Job description
Responsibilities
- Perform sponsor oversight, co-monitoring, and/or targeted on site visits based on study needs
- Serve as a sponsor point of escalation for site issues, protocol deviations, and data quality concerns from a monitoring perspective
- Assess site readiness for activation, enrollment, subject visits and study closeout.
- Support TMF completeness and inspection readiness, ensuring accurate and timely documentation
- Track samples and supplies as needed for a study
- Monitor site performance indicators, including enrollment, protocol compliance, data entry, query resolution, etc.
- Provide focused support to high risk or underperforming sites
- Support the onboarding, training and study specific readiness of CRO CRAs
- Maintain accurate trackers, documentation and status reporting for assigned activities
- Contribute to the development and improvement of clinical operations processes and tools
- Contribute to audit and inspection readiness activities and support responses to monitoring related findings.
- Other responsibilities associated with trial operations and clinical development as needed
About You
- Strong organizational skills and disciplined follow-through
- Ability to independently identify, assess, escalate, and resolve operational risks
- Strong understanding of site monitoring and CROs
- Excellent written and verbal communication
- Ability to manage multiple priorities with limited oversight
- Hands-on, solution-oriented mindset
- Comfortable operating in a small biotech / startup environment where priorities may evolve
- Strong collaboration skills across internal functions, CRO teams, vendors and clinical sites
Education and Experience
- Bachelor’s degree in life sciences or related field (required)
- 5 years of CRA experience including a minimum of three years performing independent site monitoring supporting multicenter Phase 2 or Phase 3 clinical trials.
- Previous experience in a CRO environment required; sponsor or small biotech experience preferred.
- Experience using EDC, CTMS, eTMF and related clinical trial systems.
- Strong knowledge of ICH-GCP, FDA regulations, and clinical trial conduct
- Demonstrated ability to work independently in a fast-paced, resource-lean environment
- Willingness and ability to travel domestically and internationally based on program needs, potentially up to 30-40% during periods of increased study activity.
Requirements
- Bachelor’s degree in life sciences or related field
- 5 years of CRA experience
- Minimum of three years performing independent site monitoring supporting multicenter Phase 2 or Phase 3 clinical trials
- Previous experience in a CRO environment
- Experience using EDC, CTMS, eTMF and related clinical trial systems
- Strong knowledge of ICH-GCP, FDA regulations, and clinical trial conduct
- Demonstrated ability to work independently in a fast-paced, resource-lean environment
- Willingness and ability to travel domestically and internationally up to 30-40%
Benefits
- Equity
- Medical Insurance
- Dental Insurance
- Short-Term Disability Insurance
- Long-Term Disability Insurance
- AD&D Insurance
- 401(k) Retirement Plan
- Employee Referral Program
- Free Parking
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.