Clinical Research Associate

We are seeking a Clinical Research Associate to join our team. As a Clinical Research Associate, you will have site management responsibility for clinical studies according to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, and applicable project plans 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 alongside applicable regulatory requirements
• 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 as 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
• Perform eligibility review, verify screening, informed consent procedures, and protocol requirements are adhered to according to applicable regulatory requirements
• Monitor data for missing or implausible data
• Identify deficiencies, deviations, and discrepancies, and initiate corrective action as required
• Perform monitoring tasks in an efficient manner, according to SOPs and established guidelines
• Travel to study sites, prepare and submit accurate and timely trip reports
• Independently perform eCRF review, 100% source data verification, query generation, and resolution against established data review guidelines
• 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
• Relevant and equivalent experience in lieu of educational requirements may be considered

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
• 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
• Works efficiently and effectively in a matrix environment

Preferred Qualifications:

• Thorough working knowledge of Fortrea SOPs for site monitoring
• One 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
• Personal characteristics such as leadership, problem-solving, and interpersonal skills
• Good attention to detail, methodical approach to work, and good understanding of medical and clinical research terminology and clinical research processes

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)