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, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements.
Thorough knowledge of monitoring procedures.
Basic understanding of the clinical trial process.
Fortrea may consider relevant and equivalent
experience in lieu of educational requirements.
Experience (Minimum Required): University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
Ability to monitor study sites independently according to monitoring plan, project requirements, SOPs, and ICH GCP guidelines.
Ability to work with minimal supervision.
Have an understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
Experience
AND Typically 2 years of onsite clinical site monitoring experience (SIV - Close out).
Additional details
We’re excited to announce a new opportunity to join our growing team in Australia! We are currently seeking a Clinical Research Associate II (CRA2) who is passionate about advancing clinical research and making a meaningful impact in healthcare.
As a CRA2, you will play a key role in managing and monitoring clinical trials, ensuring compliance with regulatory requirements, and fostering strong relationships with investigative sites.
This is a fantastic opportunity for professionals looking to grow their career in a dynamic and collaborative environment. Summary of
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.