Clinical Research Associate
San Diego, California (Hybrid)
Compensation: $100,000-125,000 + Bonus + Equity
Company Summary:
We are partnered with an Cell Therapy focused company looking to revolutionize the way we approach cell therapy within Oncology & Autoimmune diseases. Their proprietary approach will dramatically cut time and cost associated with other cell therapy treatments like CAR-T. Their leadership team is equally exciting as their science with their CEO and CMO successfully raising hundreds of millions in funding at other organizations while gaining successful approvals. Their strong leadership has also led to a successful IPO for this organization earlier this year. If interested in learning more don't hesitate to apply.
Primary Responsibilities:
- Organizes and supports trial managers in conducting all study team meetings, including agenda and meeting minute preparation, completion, and distribution.
- Manages the review of Site Essential Documents during study start-up, maintenance, and close-out.
- Supports the preparation and maintenance of regulatory and study-specific documentation (e.g., consent forms, site instructions, study-specific materials such as the Manual of Operations, Pharmacy binder, etc.).
- Ensures tracking and filing of essential documents in the appropriate tracking systems.
- Tracks patient status throughout the study at investigative sites.
- Maintains internal tracking systems of patient and site status to support trial and management needs.
- May review and approve trip reports, track data query reports, site visit metrics, and overall site performance.
- May perform site initiation, routine monitoring, and close-out visits at a limited number of clinical sites, as well as co-monitoring with local CRAs.
- Ensures the quality of data generated from clinical sites and assists in resolving subject eligibility and protocol deviation issues.
- May assist in the preparation of and present at investigator vendor meetings and workshops.
- Actively involved in performing study feasibility assessments.
- Provides rapid action to address both internal and site QA findings from audits.
- Coordinates the activities of third-party vendors, including metrics, accruals, process planning, and implementation.
- Routinely participates in department and clinical trial team meetings and collaborative efforts (e.g., protocol development, CRO selection, departmental initiatives, etc.).
- Supports CTM with oversight of TMF completeness, timeliness, and quality of filed documents.
Qualifications:
- 2+ years clinical operations experience in a biotech, pharma, or CRO company.
- Experience working at the site level.
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