Senior Clinical Trial Assistant (Contract)

Location
South San Francisco, CA, United States
Posted
Oct 27, 2020
Ref
462428619
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Senior Clinical Trial Assistant (Contract)

The Contract Senior CTA will assist Clinical Operations with the conduct of multi-center Phase I, II, and III clinical trials.

ESSENTIAL DUTIES:
  • Responsible for performing site feasibility and recruitment, including drafting of Site Information Questionnaires.
  • May contribute to the authoring of Clinical Operation sections of the protocols and informed consent forms
  • Participate in the design and implementation of case report forms, CRF and completion guidelines.
  • Responsible for creation and update of Investigator Site Files, including printing of required study documents.
  • Able to review data within the EDC system, performs and collates data downloads, reports and prepares summaries of data extractions for review.
  • Participates in the UAT of clinical systems, including EDC and IRT and may contribute to the authoring of systems requirements.
  • Prepares and tracks required documentation from clinical sites prior to study start-up. Tracks protocol-specific training records (e.g. managing a site-facing training portal)
  • Reviews Site Visit Reports for accuracy, quality and consistency.
  • Assists in drafting study plans, including; Clinical Monitoring, Safety, Medical Monitoring, Trial Management and eTMF Management.
  • Functions as a vendor manager, including the efficient use of web tools such as IRT, IRB web portals and central lab web portals to track the progress of studies and to ensure the studies are running smoothly.
  • 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.
  • Assists in Investigator Meeting planning.

QUALIFICATIONS/REQUIREMENTS

Education and/or experience:
  • BS/BA in biological or chemical science; BSN/RN or experience with management of clinical trials.
  • Minimum 2-years CTA 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, assertive and able to function both independently and as a team member.

Principia Biopharma is an equal opportunity employer.