Cra II

Summary of Responsibilities:

• Site management responsibility for clinical studies according to Fortreas Standard Operating Procedures ICH GCP Guidelines applicable project plans and Sponsor requirements including verification of study training records.
• Conducts site monitoring responsibilities for clinical trials according to Fortreas Standard Operating Procedures (SOPs) ICH guidelines and GCP; including Pre-study Site Initiation Process Monitoring Routine Monitoring and Close-out Visits.
• Prepares and implements project plans related to Clinical Monitoring responsibilities.
• Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements.
• Safeguards data integrity by careful source document review source document verification query generation and resolution against established data review guidelines on Fortrea or client data management systems.
• Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial.
• Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements.
• Ensures adherence to global quality control and CRA performance metrics.
• Ensures audit readiness at site level.
• 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. Ensure the protection of study subjects or patients by performing eligibility review verifying that screening informed consent procedures and protocol requirements are adhered to according to the 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.
• 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.
• 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 guideline with or without direct supervision on Fortrea or client data management systems as assigned by management.
• Assist with the administration of clinical research projects recruiting investigators (if applicable) 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 (if applicable) project team meetings and teleconferences and others as needed.
• Present training content for site initiation.
• Assist with training of new employees (e.g. co-monitoring).
• All other duties as needed or assigned.

Qualifications (Minimum Required):

• University or college degree in a related allied health profession from an appropriately accredited institution.
• Minimum 15 years of independent monitoring experience.
• Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements.
• Thorough knowledge of monitoring procedures.
• Good understanding of the clinical trial process.
• Fluent in Greek and in English both written and verbal.

Learn more about our EEO & Accommodations request here.