Summary of Responsibilities:
- Site Management: Manage clinical study sites in accordance with Fortrea’s Standard Operating Procedures (SOPs), ICH GCP Guidelines, applicable project plans, and Sponsor requirements.
- Monitoring Responsibilities: Conduct pre-study, site initiation, process monitoring, routine monitoring, and close-out visits for clinical trials.
- Project Planning: Prepare and implement project plans related to clinical monitoring responsibilities.
- Subject Protection: Verify informed consent procedures and protocol requirements, ensuring compliance with regulatory requirements.
- Data Integrity: Conduct source document review, source document verification, and resolve queries following data review guidelines.
- Regulatory Compliance: Ensure site regulatory documents and eTMF/Sponsor documents are complete and current throughout the trial duration.
- Investigational Product Management: Ensure accurate inventory and accountability of investigational products, maintaining secure storage as per protocol requirements.
- Quality Control: Adhere to global quality control and CRA performance metrics, ensuring audit readiness at the site level.
- Leadership: Act as the Lead CRA for assigned projects.
Qualifications:
- Education: University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). Equivalent experience can be substituted as appropriate.
- Knowledge: Thorough understanding of ICH GCP Guidelines and local regulatory requirements.
Experience:
- Minimum of 2 years of clinical monitoring experience.
Why Join Fortrea?
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.
