Clinical Trial Specialist, Clinical Operations

Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a world-class management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.

Job Description:

We are seeking a highly motivated Clinical Trial Associate (CTA) to be responsible for the coordination of activities (primarily administrative tasks) associated with clinical trial startup and maintenance under the direction of, or as delegated by a member of the Clinical Trial team. Responsibilities will range from clinical study coordination to data entry projects and general office work.

Responsibilities include, but are not limited to: 

• File, track and maintain study activity

• Maintain the paper and electronic Trial Master File (eTMF) and CTMS

• Coordinate execution of Non-Disclosure and Confidentiality Agreements (NDAs and CDAs) with study sites

• Participate in site start-up, interim and close-out activities, etc.

• Review regulatory packets for completeness and accuracy

• Participate in the design of study manuals, etc.

• Assist clinical teams with study supplies management

• Prepare and distribute Investigator Site Files (ISFs)

• Track departmental payments and vendor invoices

• Conduct study tracking activities (sites status, enrollment status, reconciliation activities, filing & archiving)

• Assist with meeting coordination: scheduling meetings, meeting agendas, meeting minutes, meeting materials

• Support quality review of electronic Case Report Forms (eCRFs)

• Other duties as assigned

Position Requirements & Experience: 

• Bachelor's degree in a scientific field or equivalent and 1+ years of Clinical Research experience preferred

• Sound computer skills: proficient in the use of Excel, Word, Powerpoint; some experience with EDC systems; an aptitude for being able to train rapidly on new systems and facilitate the deployment of such systems to broader audiences. Competent in an electronic environment and with the handling of documentation in such environments.

• Can exercise appropriate judgement in key situations

• Knowledge of ICH/GCP guidelines and FDA requirements for INDs and NDAs

• Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.

• Ability to work independently and as part of a team.

• Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.

• Candidates must be authorized to work in the U.S.

As an equal opportunity employer, Allogene Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact the careers email at www.allogene.com for assistance.

For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.

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