other
Posted 3 days agoCRA II
at Fortrea
Athens, GreeceOn-site
Responsibilities
- Ensure the protection of study subjects or patients by performing eligibility review, verifying that screening, informed consent procedures and protocol
- 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.
- Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy.
- Prepare and submit accurate and timely trip reports.
- Independently perform eCRF review, 100% source data verification, query generation and resolution against established data review guideline with or without direct supervision, on Fortrea or client data management systems, as assigned by 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.
- Prepare and implement study-specific monitoring plans and site Initiation slides, as assigned.
- Present training content for site initiation.
- Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects/patients into the study.
Requirements
- Responsibilities: Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records.
- responsibilities for clinical trials according to Fortrea’s Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits.
- Qualifications (Minimum Required): University or college degree in a related allied health profession from an appropriately accredited institution.