As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
This role is for upcoming future opportunities that may arise at Fortrea.
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.
- Conducts site monitoring 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.
- Prepares and implements project plans related to Clinical Monitoring responsibilities.
- 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 general quality control and CRA performance metrics.
- Ensures audit readiness at site level.
- Acts in the project role of a Lead CRA as assigned.
General On-Site Monitoring Responsibilities:
- 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/e-Clinical 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).
- Perform other duties as assigned by management.
Qualifications (Minimum Required):
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.
- Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements.
- Thorough knowledge of monitoring procedures.
- Basic understanding of the clinical trial process.
- Fluent in local office language and in English, both written and verbal.
Experience (Minimum Required):
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
AND
- A minimum of 2 years of Clinical Monitoring experience.
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.
- Standard office and/or home working environment.
- Clinical Research Unit and hospital environment (administrative only).
- Risk of eye strain.
- Will involve outside of normal office hours as required by the role.
- Travel Requirement is 60% of t