Sr. Clinical Trial Associate
Company: SciPro Agency
- Location: Boston, United States
- Work mode: On-site
- Seniority: Entry level
- Employment type: Contract
- Posted: 5 days ago
- Offer language: English
Job description
Location: On-site, Greater Boston, MA
Schedule: Full-time, 40 hours/week
Duration: 6 months
Start Date: ASAP
About the Company
Our client is an innovative, venture-backed clinical-stage biotech company that combines machine learning and biological engineering to develop new therapeutics. With a growing clinical portfolio, they are adding an experienced Senior Clinical Trial Associate to support an ongoing study.
The Role
We’re looking for a Senior CTA who can get up to speed quickly on an ongoing project and work to very high standards. You will join the Clinical Operations team and work closely with Data Management, Clinical Supply, Regulatory Affairs and Preclinical Development. You’ll support study startup, execution and closeout, maintain clinical study documentation, help develop SOPs, and manage vendor and CRO relationships. The ideal person is proactive, focused on solutions and comfortable in a matrix environment.
Key Responsibilities
- Coordinate internal and external study team meetings, including agendas, minutes and presentations
- Lead internal review of study risk logs and work with the CRO to keep risks and mitigations current, escalating program-level risks as needed
- Own study action and decision logs, and keep cross-functional trackers up to date
- Lead the authoring and review of study documents and plans, with version control
- Review site essential document packages to approve investigational product release or site activation
- Support clinical invoice tracking and status reporting
- Lead ongoing eTMF reviews to keep the TMF inspection-ready at all times
- Review protocols, eCRFs, lab data, TLFs and study reports to identify issues and recommend solutions
- Lead site coordinator calls between the sponsor and clinical sites
- Lead monthly protocol deviation log review with the CRO, and help define PD rules for each study
- Review monitoring visit reports, track trends and metrics, and follow up on action items
- Review informed consent forms and complete ICF checklists
- Contribute to SOPs, work instructions and training
- Work with legal on CDAs, work orders and MSAs, and support clinical trial insurance renewals
Requirements
- Bachelor’s degree, ideally in life sciences or a related field
- 4+ years of experience supporting clinical studies, including at least 2 years at a sponsor company
- Proven experience overseeing CROs and working in a matrix environment
- Strong knowledge of ICH-GCP, TMF management, site management, monitoring practices and protocol deviation reporting
- Solid understanding of clinical drug development, including study design and how protocol objectives affect operations
- Proficiency in MS Office (Word, Excel and PowerPoint)
- Highly organized, detail-oriented and able to manage competing priorities in a fast-paced environment
- Travel up to 10–20%, as needed
Strongly Preferred
- Oncology experience
- Early-phase (Phase I/II) trial experience
