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). This position offers mentoring, training and an excellent opportunity for career advancement at a sponsor company.
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.)
About Poseida Therapuetics, Inc
Who We Are and What We Do
Based in San Diego, Poseida Therapeutics is a clinical-stage biopharmaceutical company utilizing proprietary gene engineering platform technologies to create next generation cell and gene therapies with the capacity to cure. We are developing a broad portfolio of cell and gene product candidates in a variety of indications based on our core proprietary platforms, including our non-viral piggyBac® DNA Modification System, Cas-CLOVER™ site-specific gene editing system and nanoparticle- and AAV-based gene delivery technologies.
We are continually innovating and growing as we advance our clinical trial programs with what we believe to be transformational science. We are passionate about making an impact on the development of patient solutions with our CAR-T therapies in various cancers and gene therapies for rare diseases. Our wholly-owned portfolio of product candidates is specifically designed to overcome the limitations of current generation cell and gene therapeutics, including:
• P-BCMA-101, is an autologous CAR-T targeting BCMA that we are currently evaluating in an expanded Phase 1 clinical trial for the treatment of patients w...ith relapsed/refractory multiple myeloma.
• Our lead “off-the-shelf” product candidate, P-BCMA-ALLO1 is an allogeneic CAR-T for patients with relapsed/refractory multiple myeloma. We expect to file an investigational new drug (IND) application and initiation of a Phase 1 clinical trial in the first half of 2021.
• We have initiated a Phase 1 clinical trial and are currently dosing patients for our second autologous product candidate targeting PSMA, P-PSMA-101, for the treatment of patients with metastatic-castrate resistant prostate cancer.
• P-MUC1C-ALLO1 for multiple solid tumors is currently in pre-clinical development with an anticipated IND filing expected in late 2021
• P-PSMA-ALLO1 is our allogeneic product candidate for metastatic castrate-resistant prostate cancer, currently in development with an anticipated IND filing and initiation of a Phase 1 clinical trial in late 2022.
• Designed to include two or more fully functional CAR molecules into a T cell, we also have preclinical studies ongoing with DUAL CAR (CD19/CD20) in B cell malignancies and DUAL CAR (BCMA/CD19) in multiple myeloma where we anticipate filing INDs and initiating Phase 1 clinical trials in late 2021 and 2022. We also expect to initiate a trial in an undisclosed target in solid tumors in the future.
Gene Therapy Programs
• We are currently developing P-OTC-101, a liver-directed gene utilizing our proprietary piggyBac® DNA Modification System in combination with AAV/nanoparticle technology. P-OTC-101 is development for the in vivo treatment of Ornithine Transcarbamylase deficiency, a rare disease of the liver
• P-MMUT-101 is our second gene therapy product candidate for rare liver disease, targeting Methylmalonic Acidemia