Summary of 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.
- 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.
- 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.
- Acts in the project role of a Lead CRA as assigned.
- 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, 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.
- 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). AND
- A minimum of 2 years of Clinical Monitoring experience
- 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.
- Good planning, organization, and problem-solving abilities.
- Fluent English and Intermediate/Advanced Spanish
- Works efficiently and effectively in a matrix environment.
Preferred Qualifications Include:
- Thorough working knowledge of Fortrea SOPs for site monitoring.
- One (1) 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.
- Phase I monitoring experience.
- Life Science or Nursing qualification.
- Specific skills, systems, certifications, and/or licenses preferred.
- Personal characteristics (leadership, problem solving, interpersonal skills).
- Good attention to detail.
- Methodical approach to work.
- 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.
- Good oral and written internal and external communication. Strong interpersonal team and organizational skills, personal presentation. The ability to communicate effectively in English.
- Focus on Customer.
- Innovate and Change.
- Pursue Scientific and Process Excellence.
- Work with Others.
- Achieve Results.
- 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.
- Good analytical and negotiation skills.
- 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.
- 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 the time (traveling to study sites).
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