Clinical Research Associate

Location
San Diego, California
Posted
Sep 07, 2018
Required Education
Bachelors Degree
Position Type
Full time

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.

Primary Responsibilities:

  • 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.   

Requirements:

  • 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

About Poseida

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.