Clinical Trial Operations Associate

2 weeks ago

South San Francisco, California, United States Allogene Therapeutics Full time
Job Overview

About Allogene:

Allogene Therapeutics, located in South San Francisco, is at the forefront of biotechnology, specializing in the innovative development of allogeneic chimeric antigen receptor T cell (AlloCAR TTM) therapies aimed at treating cancer and autoimmune disorders. Our experienced leadership team is dedicated to creating a pipeline of accessible CAR T cell products designed to provide timely and reliable cell therapy solutions to a broader patient population. For further insights, please explore our website.

Role Summary:

We are in search of a driven Associate Clinical Trial Manager who will play a pivotal role in coordinating various activities related to the initiation and ongoing management of clinical trials. This position will involve a range of responsibilities from clinical study coordination to data management tasks and general administrative duties. This is a contract role within the Clinical Operations division.

Key Responsibilities:

  • Assist in all operational facets of assigned clinical trials, including study initiation, Institutional Review Board (IRB) submissions, participant enrollment, ongoing study management, and study closure.
  • Conduct tracking activities related to study progress, including site activation, participant enrollment status, and documentation management.
  • Support the Study Lead in creating, overseeing, and finalizing essential clinical documents such as study protocols, informed consent forms, and training materials.
  • Contribute to the development of region-specific documentation, including informed consent forms and materials for regional investigator meetings.
  • Assist the Study Lead in managing and monitoring the performance of vendors engaged in clinical studies, including acting as a liaison as needed.
  • Participate in the review of monitoring reports and protocol deviations to ensure the integrity of data collected.
  • Help maintain the Trial Master File (TMF) for the study.
  • Support Clinical Logistics with communications and tracking of investigational supplies.

Qualifications & Experience:

  • A minimum of a BA/BS degree or equivalent.
  • Experience in clinical research, particularly in cell therapy and/or oncology.
  • Familiarity with ICH/GCP guidelines and FDA regulations concerning INDs and NDAs.
  • Ability to adapt in a fast-paced clinical environment.
  • Strong interpersonal and communication skills.
  • Capability to work independently as well as collaboratively within a team.
  • Excellent organizational skills with the ability to manage multiple tasks effectively.
  • Proven ability to build and sustain professional relationships with vendors, staff, and investigators.
  • Experience in maintaining and managing the TMF.
  • Proactive in identifying potential study challenges and proposing solutions.
  • Must be authorized to work in the U.S.

We provide an opportunity to collaborate with talented professionals in a supportive environment. Compensation will be determined based on experience, qualifications, geographic location, and other job-related factors as permitted by law.

As an equal opportunity employer, Allogene is committed to fostering a diverse workforce. We ensure that employment decisions are made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information, gender identity and expression, veteran status, or any other non-job-related characteristics.

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