Senior Clinical Research Associate

Poseida Therapeutics

Cell and Gene Therapy Biotech

Position Summary

Poseida Therapeutics is seeking a talented Sr. Clinical Research Associate (Sr. CRA) to join our team. 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. The Sr. CRA will be responsible for overseeing and executing key clinical trial monitoring activities both in-house and at the site level, across Poseida’s development programs. This role is expected to work collaboratively with outsourced site monitoring services and/or perform site monitoring services independently (as needed).

 

Responsibilities

These may include but are not limited to:

·       Responsible for coordination/execution of study start-up tasks related to the clinical monitoring effort.  These include but are not limited to development of the clinical monitoring plan, annotated trip reports, CRA training and communication plans, site tools, ICF template development, study correspondence templates study manuals and operational plans

·       Responsible for key oversight of outsourced site monitoring services, including initial/ongoing outsourced CRA and investigational site training(s), performing co-monitoring visits, contributing to CRA team calls and supporting the monitoring team with issue resolution ensuring site compliance

·       Responsible for reviewing/approving essential regulatory document packages, reviewing site changes to ICFs, facilitating completion of clinical study agreements and budgets, and shipment of clinical supplies as directed by the Clinical Trial Manager or Project Lead

·       Serves as the primary Sponsor contact for the outsourced CRA team.  Ensures timely communication and ensures regional consistency of messaging for Sponsor directives

·       Responsible performing co-monitoring visits (as needed) to ensure that sites are following appropriate regulations, guidelines, and policies. Will document the visit in a report for the Trial Master File (TMF)

·       Responsible to ensure clinical trial sites are ready for inspection or audit.  Will provide Sponsor level representation during site audits as needed

·       Responsible to maintain and present (as requested) monitoring metrics (ex. monitoring frequency, trip report turn-around-time, resolution of monitoring action items, site file (TMF) completeness, timely SDV and query resolution)

·       Responsible to independently or in collaboration with others perform site selection, site initiation, interim monitoring and close-out visits as needed following all applicable SOPs for assigned study(s)

·       Responsible to provide thoughtful and timely reviews of key study document including but not limited to protocols, IBs, study specification documents (ex. EDC, IWRS), cross-functional plans (ex. Safety Management Plans), responses for Ethics/IRBs, vendor task orders/change orders, site budgets templates or additional study documentation or plans

·       Assist in the management, preparation of and participate in Investigator Meetings (as applicable)

·       Lead and/or participate in project team meetings and conference calls to review progress of ongoing clinical trials.  Provide key coverage for Clinical Trial Management function as needed

 

 

Requirements, Knowledge, Skills and Abilities

·       BS/BA in Biological Sciences, Life Sciences, or healthcare required with 5 plus years clinical operations experience in biotech, pharma or CRO setting (an equivalent combination of education and experience may be considered).   MS or equivalent preferred

·       At least 2 years experience as a clinical research associate (CRA) or lead CRA with on-site monitoring at academic and/or oncology centers preferred

·       Experience monitoring CAR-T, solid tumor, multiple myeloma or hematology cancer trials preferred

·       Working knowledge of Good Clinical Practice (GCP), ICH and international regulations for monitoring and overseeing clinical trials

·       Ability to travel up to 50%

·       Ability to deliver results and execute on required activities individually and in a team setting

·       Organized and detail-oriented

·       Strong communication skills in a compact clinical team working with aggressive timelines

·       Advanced written, oral, and interpersonal communication skills, including proficient knowledge of medical terminology

·       Computer skills (MS Office products, word processing, spreadsheets, etc.)

 

Apply at: https://recruiting.paylocity.com/recruiting/jobs/Apply/428335/Poseida-Therapeutics-Inc/Senior-Clinical-Research-Associate

To apply for this job please visit recruiting.paylocity.com.

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