Responsibilities:
Assumes responsibility for effective management of research protocols initiated at Macoa Health including but not limited to:
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Patient recruitment and consent, Scheduling and retention in addition to scheduled visits for study events
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Creates protocol specific documentation reference tools and source documents
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Management of patient visits, documentation and binders for the study.
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Responsible for day-to-day regulatory management including, DOA, SAE reporting, deviations, and amendment review.
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Assures adherence to safety guidelines and protocol schedule for patient treatment with oversight of the Principal and Sub-Investigators.
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Organization and coordination of Monitor/audit visits as required
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Responsible for EDC data entry and addressing of any queries generated
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Additional responsibilities will be assigned as needed
Minimum Qualifications:
· Three years of relevant experience in clinical research
· Blood draw experience
· Experience with EDC and Source Data (eSource a plus)
· Basic understanding of regulatory
· Experience with Microsoft Office
Skills:
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Knowledge of good clinical practice, FDA, OHRP, HIPAA policies
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Excellent interpersonal skills to deal effectively with clinicians, patients, administrators, auxiliary personnel, regulators, monitors and sponsors.
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Confident self-starter
Send your resume to info@macoa-health.com
