CRA

San Francisco, CA | Clinical Operations

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Job Description

Job Responsibilities

  • Support the Clinical Operations Manager with various aspects of a trial execution to ensure that studies are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines.
  • Assist with key study parameters (e.g. start-up activities, enrollment, site management, data collection, data reviews, site feasibility, database lock, etc.) and proactively identify solutions within the clinical team when issues arise.
  • Develop and review informed consent forms, case report forms, study manuals, and other study operations material.
  • Assist with evaluating, selecting, and managing clinical study sites.
  • Assist in the evaluation of CROs, other vendors, and systems.  Negotiate contracts/budgets with CROs and other vendors as applicable.
  • Track/maintain study metrics/progress and providing routine study updates to the project team/sub-team.
  • Develop/review action plans to address issues with investigational sites and/or CROs/vendors.
  • Assist with creation of study specific tools and manuals to ensure timeliness, standardization and control of data quality.
  • Serve as a primary contact for sites.
  • Review and provide input on regulatory documents and Clinical Trial Application documents.
  • Review and negotiate clinical site study contracts and budgets.
  • Assist, coordinate, and present at Investigator Meetings and CRA Training meetings as requested.
  • Perform Sponsor Oversight Visits as required/requested.
  • Support internal and regulatory audits of clinical trial sites and vendors and assist with resolution of audit findings.
  • Coordinate/participate in clinical team meetings/teleconference/WebEx and prepares agendas, meeting minutes, and track action items.
  • Identify and escalate issues appropriately.
  • Ensure timely entry and updates to ‘Clinicaltrial.gov’ on an ongoing basis.
  • Manage internal trial master files.
  • Create/revise/review departmental SOPs, as requested.
  • Performs other work-related duties as assigned.

Skills & Requirements

Qualifications

  • Knowledge of FDA regulatory requirements and ICH/GCP guidelines.
  • Demonstrated proficiency in supporting the operational activities of a clinical trial, from start-up to close-out. Experience with working on global trials a plus.
  • Strong organizational skills, ability to prioritize and multi-task.
  • Excellent verbal and written communication skills.
  • Demonstrated problem-solving and negotiation abilities.
  • Ability to work as part of a team/active team participant.
  • Computer proficiency (Outlook, MS Word, Excel, and Powerpoint). 

Education and Experience

  • Bachelor’s degree in a scientific discipline or health-related field.
  • Minimum of 5 years clinical research experience and at least 3 years’ experience as a CRA in a biopharmaceutical company or CRO.
  • Previous experience with Global oncology clinical trials is strongly preferred. 

Working Conditions

  • Willingness to travel as necessary, up to 25%. consistent with project needs.