Contract Clinical Trial Operations CRA

Category: In-House CRA
Job #: 10720
Utilization: 100%
Location: Commutable distance to Valencia, CA
Job Type: 1099
Therapeutics: No TA Required

One of our Sponsors is looking for Trial Operations Clinical Research Associates to join their team. These key individuals will be a primary point of contact for the operational set-up, oversight/management and close out of clinical trials. This is a huge growth opportunity for someone who wants to work directly for very well established and highly reputed sponsor.

Job Responsibilities:
  • Study Development:
    • Participate in the planning, executing, and management of clinical studies in conjunction with the Project Manager / Project Leader.
    • Provide startup input to the following documentation: case report form (CRF) development, IRB submissions, investigator agreements, informed consent form (ICF) development, clinical trial related operational manuals, training materials, and various clinical trial plans (e.g., monitoring, risk mitigation, communication etc. plans) and budget planning.
    • Provide assistance / input to investigator and site selection including helping to identify, evaluate and select investigative sites.
    • Provide input to clinical planning tools and systems used (e.g., CTMS, IXRS etc).
  • Study Management:
    • Organize and direct internal team meetings, investigator meetings, and other study-specific meetings as required.
    • Support and intermittently lead the development and/or review of clinical study plans, presentations or project/study-related documents.
  • Vendor Management / Oversight:
    • Participate in the selection of study vendors including contract monitors, CROs.
    • Perform daily management of vendors, including but not limited to overseeing CRO and contract monitor performance as well as provide oversight to bioanalytical labs.
    • Review monitoring trip reports.
    • Raise issues and track resolution of vendor action items, ensuring vendors comply with all required standards.
    • Assist with vendor contract and budget preparations, including negotiations and life cycle management throughout clinical study.
  • Site Management:
    • Manage study activities from start-up through close-out, and track and review patient status including recruitment.
    • Communicate with clinical trial sites regarding all study logistics including contract agreements, support materials and training.
    • Assist in the IRB/EC application process, including review of informed consent / HIPAA forms for conformance to pertinent government regulations.
    • Manage study site startup including set-up, ongoing quality review, and final reconciliation of study documents.
    • Review site regulatory documents / packages including the obtainment of appropriate country/site insurance.
    • Develop, organize and manage training for study team, investigational sites, and vendors.
    • Manage clinical site budgets, investigator payment processes and handles invoices related to projects assigned.
    • Escalate study and team issues to project leader.
  • Data Management:
    • Own in-house review of clinical data listings for completeness and accuracy, escalating issues as needed.
    • Perform risk management, proactively identifying risks with associated recommendations and action plans to avoid or mitigate said risks.
    • Ensure study regulatory files are collected, inventoried and filed as per Sponsor requirements.
    • Ensure study materials and supplies are available in a timely manner at the location where needed.
    • Responsible for the maintenance and updating of data as appropriate in project management tools including CTMS. Implements and maintains project processes and tracking systems (i.e., Screening and Randomization status) and reports to management.
Job Qualifications:
  • BA or BS a preferred requirement with Bachelor’s degree in a scientific discipline or related healthcare.
  • A minimum of 2 years’ experience as an In-house CRA, CTA or in a comparable role in the biotech/pharmaceutical industry.
  • Strong clinical operations experience with prior experience performing study start-up activities and vendor contract and budget preparations including working with CTMS and eTMF systems, experience with ICF review, previous experience working with IRBs.

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