Perform site qualification, site initiation, interim monitoring, and close-out visits ensuring regulatory and protocol compliance. Review completion of proper informed consent procedures. Ensure accurate data reporting via review of site source documents and medical records. Interpret data to identify protocol deviations and risks to subject safety/data integrity. Generate queries and manage resolutions with site personnel. Perform investigational product accountability. Evaluate execution of study protocol at the site level. Evaluate overall performance of site and site staff to provide recommendations regarding site-specific actions; communicate/escalate serious issues to the project team. Obtain, review, and process essential regulatory and administrative documents. Conduct audits of essential regulatory documents to ensure completeness, accuracy, and regulatory compliance. Review site-level activities / communication to ensure project objectives, deliverables and timelines are met. Act as primary liaison with study site personnel. Participate in the identification and selection of investigators and clinical sites. Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. Provide clinical and technical support for project team. Suggest improvements and/or innovations to systems. Provide mentoring / training to less experienced staff.
The position requires Bachelor’s degree or higher (or foreign equivalent) in pharmacy, life sciences, medical science or a related field and 3 years of experience in job offered or related clinical monitoring position.
All stated experience must include 2 years of experience in the following:
- Good Clinical Practice/ICH Guidelines;
- Clinical research;
- Clinical monitoring;
- Microsoft programs including: Word, Excel, PowerPoint, Excel, and OneNote;
- Industry systems (CTMS, INFORM, IWRS, EDC); and,
- Presenting clinical research findings to an audience.
Individual may telework from any location in the US. Travel up to 80% of time.
Please apply online via the Careers section of https://www.syneoshealth.com.
Primary Location North America - US Home-Based
Job Clinical Monitoring
Travel Yes, 75 % of the Time
Employee Status Regular