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Senior, Clinical Trial Assistant (Contract Position)

Aduro Biotech Berkeley, CA
  • Expired: October 01, 2019. Applications are no longer accepted.
Senior, Clinical Trial Assistant (Contract Position) LOCATION: Berkeley, CA - USA REPORTS INTO: Director, Clinical Operations SUMMARY & SCOPE:

This is a full-time, contract position for a Sr. Clinical Trial Assistant. The Senior CTA will provide comprehensive administrative and clinical trial project support to Aduro's Clinical Operations group. This position requires a motivated individual with strong, professional written and verbal communication skills, good organization and attention to detail, and the ability to consistently provide high quality work while managing competing priorities and maintaining tight timelines. This person must be interested in working in a fast-paced, team-oriented environment and be willing to work beyond their job scope to achieve department and company objectives.

PRIMARY RESPONSIBILITIES:
  • Coordinates tracking of a clinical trial(s) under the oversight of the Clinical Trial Manger (CTM)
  • Organize, maintain and participate in audits and close out of the Trial Master File (TMF/eTMF)
  • Collect, track and conduct initial review for completeness of site regulatory documents for IP release
  • Maintains multiple tracking spreadsheets following the progress of assigned clinical trials, such as study subject tracking, essential document tracking, and sample tracking
  • Tracks and coordinates CRO and third-party vendor activities
  • Receives and reviews all regulatory documents from sites for accuracy and compliance to company SOPs and federal guidelines, tracks all information for reference, and maintains documentation as required
  • Ensures timely updates are provided to Regulatory Affairs for updating of 'Clinicaltrial.gov' (site updates/changes)
  • Track and route new CDAs, contracts and POs through established legal approval process (CTAs, MSAs, work/task orders)
  • Performs first pass review of all site and vendor invoices including tracking and generation of monthly/quarterly accruals for finance
  • Assists with the development of site tools and clinical trial start up activities
  • Assists and/or contributes to the creation and maintenance of study materials for clinical studies, including but not limited to site and CRA training material, regulatory document templates, study binders, study plans/manuals, study communications and presentations
  • Participate in the EDC and IXRS specification process, as appropriate
  • Communicates directly with sites, Site Management Organizations (SMOs), Contract Research Organizations (CROs) and field CRAs to obtain updated information, essential documents, etc. to assist with driving start-up, study conduct, and/or close out activities
  • Assists with tracking of clinical trial progress including status update reports, as requested
  • Assists with collection of final sign off of project and study-related documents including: informed consent forms, monitoring plans, synopses, protocols and amendments, and other documents, as required
  • Participates in clinical teams, including attending required meeting, and interacts in a positive, professional manner.
  • Assists with the organization, management and conduct of internal team meetings, investigator meetings and other trial-specific meetings
  • Assists Immune Monitoring/Biomarker group in tracking of clinical lab samples, including tracking of sample shipments and reconciliation
  • Utilize EDC/CTMS systems to acquire and synthesize data, metrics, or reports as necessary (enrollment data, randomizations, data cleaning, SAEs, etc.) for CTM/AD, specific meeting or management updates
  • May assist CTM in tracking and follow up of monitoring visit reports and unresolved issues
  • Assist in tracking of trial IP and development of Pharmacy Manuals
REQUIREMENTS:
  • High School diploma required; BA/BS, AA/AS degree strongly preferred
  • At least 1 year of work experience supporting clinical trials
  • Basic knowledge of clinical trial operations, ICH GCP Guidelines and other applicable regulatory requirements preferred
  • Basic understanding of medical terminology and clinical activities in relation to execution of Clinical Development Plans
  • Experience in MS Office products (e.g. Excel, Power Point & Word)
  • Ability to prioritize and manage completing priorities


Aduro Biotech, Inc. is at the forefront of discovery, development and commercialization of breakthrough immunotherapies. We provide a workplace where employees excel, thrive and deliver value to patients, their families and our partners. Aduro's headquarter office is located in Berkeley, California with an international office in Oss, The Netherlands.

Aduro Biotech, Inc. offers a competitive salary and benefits package. We arean Equal Opportunity Employer.

Aduro Biotech

Address

Berkeley, CA
USA