Clinical Research Associate
Poseida Therapeutics, Inc. is seeking a talented Clinical Research Associate to join our team in San Diego, CA. This position offers an excellent opportunity for a highly motivated individual to contribute to innovative clinical trials for new CAR-T, gene editing and gene therapy products in an exciting and dynamic environment focused on cutting-edge gene editing technology. Primarily, the role will be responsible for clinical activities related to one or more clinical trials and performing or managing daily in-house and on-site operations associated with these trials.
- Perform monitoring at participating clinical sites.
- Conduct co-monitoring visits to oversee CRO personnel and study conduct at the site.
- Perform monitoring and other data management at participating sites, CROs, Core Labs, etc., as needed to ensure compliance with the Investigational Plan and appropriate regulations, guidelines, and policies.
- Assists in overseeing clinical studies to ensure compliance with the study protocol, timeline and budget.
- Coordinates contract vendors and Clinical Research Organizations activities to ensure all are conducted according to study plans, timelines, budgets, and relevant SOPs.
- Oversees investigational site startup activities, including the preparation and review of study documents (e.g., ICFs, CRFs, study manuals, study binders, etc.), reviewing/approving essential regulatory document packages, reviewing site changes to ICFs, facilitating completion of clinical study agreements and budgets, and shipment of clinical supplies.
- Reviews clinical databases on a real time basis to identify/resolve data entry issues, tracks the query process to identify/report evolving trends in the data.
- Assist with data review and analysis, generate standard figures and graphs.
- Coordinates and maintains relevant tracking systems for clinical lab samples, subject screening, enrollment, study visits, data entry, query resolution, etc.
- Assists with protocol, case report form, source document template development, internal SOP/guideline development, final report preparation.
- Assists in the organization and preparation of and participates in Investigator Meetings (as applicable)
- Participates in project team meetings and conference calls to review progress of ongoing clinical trials.
- BS or MS in cell biology, molecular biology, other life science or healthcare required.
- Experience managing clinical trials in oncology
- Clinical Research 4-6+ years’ experience, biotech, pharma, or CRO setting
- Understanding of chimeric antigen receptor cell (CAR T cells) preferred
- Working knowledge of Good Clinical Practice (GCP) and US and international regulations for clinical trials
- Ability to travel up to 25%, generally within the US
- Ability to deliver results and execute on required activities individually, in a team setting
- Organized and detail-oriented
- Strong communication skills in a compact clinical team working with aggressive timelines
- Superior communication/negotiation skills with clinical investigators and coordinators
- Advanced written, oral, and interpersonal communication skills, including proficient knowledge of medical terminology.
- Computer skills (MS Office products, word processing, spreadsheets, etc.)
- Proficiency in Prism is preferred
Poseida Therapeutics is translating best-in-class gene engineering technologies into lifesaving cell therapies. The company is developing CAR T-cell immunotherapies for multiple myeloma, prostate and other cancer types, as well as gene therapies for orphan diseases. P-BCMA-101 is Poseida’s lead CAR-T therapy currently in Phase 1 clinical development for the treatment of multiple myeloma. Poseida has assembled a suite of industry-leading gene engineering technologies, including the piggyBac™ DNA Modification System, TAL-CLOVER™ and Cas-CLOVER™ site-specific nucleases, and Footprint-Free™ Gene Editing (FFGE). For more information, visit www.poseida.com.