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Principia Biopharma

Clinical Trial Associate

Development Operations · South San Francisco, California
Department Development Operations
Employment Type Full Time
Minimum Experience Entry-level

OVERALL SUMMARY OF POSITION:

Assists Clinical Operations department and team to support the conduct of multi-center Phase I, II, and III clinical trials.

ESSENTIAL DUTIES:

  • Responsible for assisting with site feasibility and recruitment, including drafting of Site Information Questionnaires.
  • Review assigned clinical documents for clarity and accuracy
  • Participate in the design and implementation of case report forms (CFRs), CRF and completion guidelines.
  • Responsible for creation and update of Investigator Site Files from template supplied, including printing of required study documents.
  • Review of data fields within the electronic data capture (EDC) systems, including performing and collating and downloading reports to support study management and data review
  • Participates in assigned activities related to user acceptance testing (UAT) of clinical systems, including EDC and interactive response technology (IRT) and may contribute to the authoring of systems requirements.
  • Prepares and tracks required essential regulatory documentation from clinical sites prior to study start-up.
  • Tracks protocol-specific training records (e.g. managing a site-facing training portal)
  • Assist in the review of Site Visit Reports for accuracy, quality and consistency.
  • Assists in drafting study plans, including; Clinical Monitoring, Safety, Medical Monitoring, Trial Management and electronic Trial Master File (eTMF) Management.
  • Assist with activities related to management of study vendors.
  • Assist in performance of TMF QC and reconciliation of findings.
  • Represents department in a professional manner; establishes and maintains good relationships with investigators and all other study personnel.
  • Assists in Investigator Meeting planning.
  • Builds stable relationships internally.

QUALIFICATIONS/REQUIREMENTS:

Education and/or experience:

  • BS/BA in biological or chemical science; BSN/RN or experience with management of clinical trials.
  • 1 year in a clinical trial setting as a study coordinator or study assistant experience preferably in biomedical or pharmaceutical field.
  • Certificate in Clinical Trial Design & Management will be considered in lieu of full years of experience.
  • Must be able to work from the South San Francisco office (currently not considering fully remote applicants)

Special skills/knowledge:

  • Effective communications skills.
  • Excellent organizational skills.
  • Working knowledge of the Microsoft Office Suite (i.e., Word, Excel, Access, PowerPoint, Adobe Acrobat)
  • Excellent attention to detail.
  • Self-motivated and able to function both independently and as a team member.

 

Principia Biopharma is an equal opportunity employer. 

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  • Location
    South San Francisco, California
  • Department
    Development Operations
  • Employment Type
    Full Time
  • Minimum Experience
    Entry-level