Description
We are seeking a Clinical Research Associate (CRA) to join our team. As a CRA, you will have site management responsibility for clinical studies according to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, and applicable project plans and Sponsor requirements.
Responsibilities:
- Conduct site monitoring responsibilities for clinical trials, including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits
- Prepare and implement project plans related to Clinical Monitoring responsibilities
- Ensure the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements
- Safeguard data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines
- Confirm Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial
- Guarantee that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements
- Ensure adherence to global quality control and CRA performance metrics
- Ensure audit readiness at site level
- Act in the project role of a Lead CRA as assigned
General On-Site Monitoring Responsibilities:
- Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects/patients into the study
- Perform eligibility review, verify screening, informed consent procedures, and protocol requirements are adhered to according to applicable regulatory requirements
- Ensure the integrity of the source data reported by careful source document review
- Monitor data for missing or implausible data
- Ensure study data completeness, accuracy, consistency, and compliance
- Identify deficiencies, deviations, and discrepancies, and initiate corrective action as required
- Perform required monitoring tasks in an efficient manner, according to SOPs and established guidelines
- Travel, including air travel, may be required and is an essential function of the job
- Prepare and submit accurate and timely trip reports
- Independently perform eCRF review, 100% source data verification, query generation, and resolution against established data review guidelines
- Assist with the administration of clinical research projects, recruiting investigators, collecting investigator documentation, and site management
- Update, navigate, and maintain Fortrea or study/Sponsor-specific trial management tools/eClinical systems
- Track IP shipments and supplies, as needed
- Track and follow-up on serious adverse events as assigned
- Work closely with the study team, align monitoring to critical study timelines ensuring study deliverables are met
- Prepare and implement study-specific monitoring plans and site Initiation slides, as assigned
- Attend investigators' meetings, project team meetings, and teleconferences, and others as needed
- Present training content for site initiation
- Assist with training of new employees
Qualifications:
- Minimum 2 years of site monitoring experience
- Oncology experience is required
- Experience in Start-up, site maintenance, and Close-outs