Job Description

We are seeking a highly organized and experienced Clinical Research Associate (CRA) to assist with oversight of the day-to-day operational aspects of clinical trials. The Sponsor CRA is responsible for monitoring oversight, co-monitoring, and site management work to ensure that the CRAs working under the CRO(s) and the sites conducting the studies on behalf of our client, follow all applicable regulations, guidelines, and sponsor requirements. The CRA will work closely with study teams, investigators, and research sites to ensure the successful execution of clinical trials from start up through close out.

Key Responsibilities

Site Management and Monitoring:

• Perform site co-monitoring visits at various timepoints in the study (selection, initiation, monitoring and close-out visits) to ensure CRAs working for the CRO on behalf of the sponsor, are monitoring in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• May conduct independent monitoring visits across the life cycle of a trial as required.
• Assist with site feasibility efforts, investigator selection, and site initiation activities.
• Evaluate patient safety, data quality/integrity, and protocol compliance at study sites, including adherence to applicable regulations.
• Identify and resolve any issues related to the conduct of the study, data accuracy, or site performance.
• Escalate quality issues as appropriate.

Study Documentation and Reporting:

• Create tracking tools, training materials, and presentations as needed.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, data query generation and resolution, AEs, and protocol deviations.
• Ensure copies/originals (as required) of site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
• Create and maintain appropriate documentation regarding CRO CRA monitoring oversight, including monitoring visit findings, tracking monitoring visits according to the Clinical Monitoring Plan, and by submitting regular co-monitoring visit reports.
• Ensure timely reporting of safety data and AEs to the appropriate stakeholders.

Financial Management:

• May be accountable for site financial management according to executed clinical trial agreement and to review/approve site invoices.
• May be accountable to review CRO CRA expense reports to ensure that expenses fall within the parameters established between sponsor and CRO at the execution of the contract.

Training and Support:

• Provide training and support to CRO CRAs and site staff regarding study protocols, GCP and applicable regulations.
• Support development of project subject recruitment plan on a per site basis.
• Support sites to adapt, drive, and track subject recruitment plans in line with project needs to enhance predictability.
• Assist CRO CRAs and vendors to troubleshoot site issues.
• May present at Investigator Meetings.
• May contribute to Study Newsletters.

Regulatory Compliance:

• Ensure that study conduct complies with all applicable federal, state and local regulatory requirements (e.g. FDA, EMA, ICH-GCP).
• Review and ensure that all required regulatory documentation is submitted and maintained.

Collaboration and Communication:

• Establish regular lines of communication with CRO CRAs and sites to manage ongoing project expectations and issues.
• Collaborate and liaise with study team members for project execution support as appropriate.
• Attend and actively participate in study team meetings by providing Clinical Operations updates.
• Collaborate with the clinical project team to prepare for audits and inspections by regulatory agencies.

Qualifications

• Education and Certifications: Bachelor's Degree or higher. A degree in life sciences discipline or health care preferred. An equivalent combination of education, training, and experience may be accepted in lieu of a degree.

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