Clinical Trials Monitoring Specialist
3 weeks ago
As a Clinical Trials Monitoring Manager, you will design, plan and conduct clinical research trials by effectively coordinating the activities of study coordinators and investigators. This role ensures compliance with study protocols, FDA and International regulations, IRB and/or Ethics committees requirements, and overall clinical objectives.
Main Responsibilities
• Monitor and assess all data documentation, reports, records, transcripts, exam results for consistency with case report form and determine if clinical trial/study subject documentation is within parameters of study hypothesis.
• Develop and deliver technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements and training new employees on trial and study related activities.
• Provide oversight of and insights into trial activities, including protocol compliance, enrollment, monitoring deviations, data quality to principal investigators and support staff, and study sponsor management and leadership staff.
• Contribute to the development of clinical protocols, informed consent forms, and case report forms, as well as team projects.
• Validate investigational device accountability by tracking the history of investigational devices to the field sites and through final disposition.
• Utilize excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills in this role.
• Strong knowledge of FDA regulatory requirements related to the conduct of clinical studies is required.
Qualifications
• Bachelor's degree in Life Sciences or related field is highly preferred. Associates or equivalent 5-10 year clinical degree in Life Sciences or related field or equivalent in work experience is required.
• GCP/ Clinical research certification is strongly preferred (ACRP or SoCRA, Clinical Coordinator/CRA certification).
• Excellent communication, presentation, and interpersonal skills are a must.
What We Offer
• A dynamic and supportive work environment
• Opportunities for professional growth and development
To apply
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