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): Bachelor or Master 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): External Candidates: Bachelor or Master 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.
Qualifications Include: Thorough working knowledge of Fortrea SOPs for site monitoring. Two (2) or more additional years of
experience in a related field (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
Life Science or Nursing qualification.
Good understanding of medical and clinical research terminology and clinical research processes.
An understanding of the basics of physiology, pharmacology, and medical devices (when applicable).
Good understanding of the principles of ICH GCP, ISO 14155 (if applicable) and local regulatory requirements.
Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications.
The ability to communicate effectively in English. Focus on Customer.
Ability to maintain confidentiality of data and information during interactions with staff at all levels and across studies and sponsors.
Demonstrated ability to conduct clinical operations activities most effectively and efficiently.
Experience using e-clinical systems [e.g., clinical trial management system (CTMS)]. For medical device positions,
experience in providing customer service to device end users.
Physical Demands/Work Environment: Must be able to sit at a computer for long periods of time.
Must be able to use hands to finger, handle or touch objects, tools or controls, including a computer keyboard, for up to 8 hours per day.
Experience
AND A minimum of 2 years of Clinical Monitoring experience.
Internal Candidates: Internal candidates with a minimum of 2 years of Clinical Monitoring experience.
Additional details
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.
Acts in the project role of a Lead CRA as assigned.
requirements are adhered to according to the applicable regulatory requirements.
Travel, including air travel, may be required and is an essential function of the job.