Description
We are seeking a Clinical Research Associate to manage clinical studies according to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, and Sponsor requirements.
Responsibilities:
- Conduct site monitoring responsibilities for clinical trials, including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits
- Prepare and implement project plans related to Clinical Monitoring responsibilities
- Ensure the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to
- Safeguard data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines
- Confirm Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial
- Guarantee that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements
- Ensure adherence to global quality control and CRA performance metrics
- Ensure audit readiness at site level
- Act 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
- 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
- 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
- Assist with the administration of clinical research projects, recruiting investigators, 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, project team meetings and teleconferences, and others as needed
- Present training content for site initiation
- Assist with training of new employees
Qualifications:
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution
- 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:
- A minimum of 2 years of Clinical Monitoring experience
- 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
Preferred Qualifications:
- Thorough working knowledge of Fortrea SOPs for site monitoring
- One (1) or more additional years of experience in a related field
- Phase I monitoring experience
- Life Science or Nursing qualification
- Specific skills, systems, certifications, and/or licenses preferred
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)