Clinical Trial Associate

Clinical Operations · Redwood City, California
Department Clinical Operations
Employment Type Full-Time
Minimum Experience Experienced

The clinical trial associate role supports clinical trial start up, maintenance and close out activities.  The position coordinates and tracks all study documentation including regulatory documents, study drug documents and clinical trial payments.  In addition, this position provides coordination of other functional activities that relate to the conduct of clinical trials.  This is an onsite role.

 

Responsibilities:

  • Set up and maintain clinical trial filing system (electronic and paper based) to ensure accuracy and regulatory compliance;
  • Support clinical study documentation preparation, tracking and maintenance;
  • Maintain and perform periodic review of in-house study site records for completeness and accuracy;
  • Prepare and send study-related documents and materials to sites, CROs or development partners;
  • Assist in the preparation and maintenance of Clinical Study Agreements and Confidentiality Agreements;
  • Develop and maintain effective tracking systems to ensure updates of regulatory documents;
  • Initiate request for investigator, site and vendor payments;
  • Help facilitate shipment study supplies to study sites;
  • Monitor drug expiration and inventory;
  • Maintain and organize reference materials related to the indication;
  • Maintain systems to track study metrics and general study information;
  • Coordinate logistics and materials of formal meetings as needed (e.g. data review meetings and centralized investigator meetings);
  • Attend study, project and departmental meetings;
  • Support development of relevant tracking tools and other internal processes to increase departmental efficiency; and
  • Support other job-related duties as assigned by the Clinical Lead or designee.

 

 

Education and Experience Requirements:

  • Bachelor’s degree in a related scientific discipline with at least 2 years related experience; Masters a plus but not required;
  • Working knowledge of GCPs, Trial Master Files, ICH guidelines or experience working in a regulated environment;
  • Professional demeanor and ability to work as a team member;
  • Experience with MS Office Suite (Word, PowerPoint, Excel, Project);
  • Ability to coordinate and prioritize multiple tasks;
  • Good problem-solving skills;
  • Good written and verbal skills in English;
  • Ability to travel to attend periodic meetings (less than 10%)

 

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  • Location
    Redwood City, California
  • Department
    Clinical Operations
  • Employment Type
    Full-Time
  • Minimum Experience
    Experienced