Location: Norfolk, VA
Company: Isothrive
charts and reach out to potential study participants to let them know about the study. While you will work directly with the study site, you will report remotely to the VP, Clinical Research. Key Responsibilities: Demonstrate knowledge and understanding of the Federal regulations and guidelines governing the protection of human subjects, e.
g. FDA, GCP/ICH, and HIPAA regulations. Understand the inclusion/exclusion criteria and identify potential subjects for the clinical research study. Perform daily chart reviews on scheduled patients from the private practice (clinic and endoscopy schedules) to find potential subjects prior to patients being seen. Conduct phone screens and/or in-person
interviews discussing medical/surgical history to determine eligibility. Measure and report the effectiveness of recruitment activities by documenting all chart reviews/in-person interviews completed and eligibility status; for those not eligible, document reason and report weekly to Site PI and immediate supervisor.
Provide potential subjects with IRB-approved QR code and/or URL for completing brief on-line survey and assist in scheduling screening call with remote study coordinator. Perform other duties that may be requested or assigned. Experience: Medical knowledge and knowledge of medical terminology GI experience preferred? Medical chart review experience required? Clinical Trials
experience required? Strong communication and interpersonal skills?
Warm demeanor? Superior attention to detail and ability to maintain confidentiality? Excellent verbal and written communication skills, including the ability to read, write, and speak fluent English Education: High school diploma/GED required; Bachelor? s degree preferred? Minimum 2 years clinical trial recruitment experience required? Participate in and maintain certifications, licensure and credentialing as required by the Sponsor. Certifications & Licenses: Human Subject Protection Certification (Required)? Good Clinical Practice Certification (Required)? Certified Clinical Research Professional (Preferred) Work Schedule: Contract position?
Part-time 20 hours per week days/hours to be determined by PI/practice? Participation in weekly remote research team meeting each Thursday afternoon is expected (5:30-6:30 pm Eastern). Please send resume and cover letter to:
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