Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Join a team that approaches each opportunity with foresight, character, resilience, and innovation.
Responsibilities:
1. Assist with the development and negotiation of study budgets for clinical trial centers.
2. Assist in the development of clinical protocol amendments, informed consents, CRF source document design, monitoring plan, site instruction manuals, protocol-specific training documentation, administrative letters, and other project-related documents.
3. Serve as liaison between the project management team, clinical sites, site investigators, study coordinators, staff members, and study CRO.
4. Review site data quality trends via trip reports and review data including queries and protocol deviations.
5. Assist with the overall management of the project Trial Master File.
6. Assist in providing data to support the annual progress reports and the final clinical study report.
7. Oversee the study site staff to assess protocol compliance and proper data collection, including handling, storage, and shipment of investigational products.
8. Review source data and case report forms for accuracy, completeness, and data integrity, and resolve any data issues.
9. Prepare visit reports and correspond with sites.
10. Monitor clinical studies of investigational products, including qualification, initiation, interim monitoring, and closeout visits.
11. Review and report on site enrollment, subject status, findings at monitoring visits, protocol deviations/exceptions, and serious adverse events.
Qualifications:
1. Minimum 3+ years of direct monitoring and investigative site management experience on the sponsor side.
2. BA/BS degree and/or advanced degree in biological sciences or related field, or equivalent experience, education, or training, along with previous Sr CRA experience.
3. Excellent organizational, interpersonal, communication, and problem-solving skills.
4. Flexibility with changing priorities.
5. Ability to perform and prioritize multiple tasks efficiently.
6. Extensive knowledge of ICH, ISO, and FDA regulations.
7. Willingness to travel domestically, approximately 50%, depending on site locations.
8. Proficiency in Microsoft Word, Excel, and PowerPoint.
Please note that if you are not a passport holder of the country for the vacancy, you might need a work permit. Check our Blog for more information.
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Created on 02/06/2025 by TN United Kingdom
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