TMF Sr. Clinical Trial Associate

BioPhase in San Diego, CA

  • Industry: Pharmaceutical/Biotechnology - Others
  • Type: Full Time
position filled
Clinical Trial Associate with Expertise in Trial Master File *Direct Hire *Position is located in Mission Valley with the option to work remotley 1-2 days/week *Must have experience with TMF, this company is bringing a TMF in house along with tracking and filing *Excellent work environment Essential Responsibilities: Prepares, handles, distributes, files and archives clinical documentation and reports Independently maintains the internal Trial Master File (TMF) in accordance with the DIA’s reference model and periodically reviews the TMF(s) being maintained by the Contract Research Organization (CRO) to ensure accuracy, completeness and adherence to the DIA’s reference model Accurately updates and maintains clinical systems within project timelines Assist, as directed, with taking and issuing meeting agendas and minutes for designated clinical team meetings Maintains tracking information for study activities Schedules meetings with internal and external teams, as needed Partners with other functional areas to track clinical samples Assist with clinical data review and informed consent development and review as necessary Assist Clinical Research Associates with monitoring of data including query resolution Assist with study feasibility assessments for new protocols Perform administrative tasks to support team members with clinical trial execution, as needed All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with the company’s Standard Operating Procedures Other projects as assigned based on clinical operations needs

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