Assists in the research efforts with the opportunity to implement and coordinate human factors in healthcare research projects in compliance with GCP and FDA regulations.
Bachelors degree in a health/clinical or engineering related field.
Previous work in a health/clinical or engineering related field.
No special certification, registration or license required.
Knowledge, Skills & Abilities
Strong organizational skills with the ability to manage multiple duties with close attention to detail required. Computer skills (Microsoft Office) preferred.
Primary Duties and Responsibilities
Contributes to the achievement of established department goals and objectives and adheres to department policies, procedures, quality standards and safety standards. C omplies with governmental and accreditation regulations.
Coordinates and completes research projects for the National Human Factors in Healthcare team in accordance with FDA and GC P guidelines.
Coordinates protocol implementation and document processing for research projects, including but not limited to, participant screening & recruitment, informed consent process, study enrollment, and participant follow up, manuscript editing, and database maintenance.
Communicates with investigators and colleagues to ensure effective study implementation and progress.
Assists with management and maintenance required regulatory files.
Participate in conferences, departmental meetings, continuing education, investigator meetings, and team meetings as assigned.
Administers study protocols as needed.
Monitors patients study progress to fulfill protocol and sponsor requirements. (C ompletes all study documents in a timely manner).
Accesses electronic medical records to obtain records supporting human factors projects, including, but not limited to discharge summaries, progress notes, consult notes, ultrasounds, laboratory tests, vital signs measurement, health status assessment and adverse event monitoring.
Prepares and analyzes regular reports of research activity, including IRB continuations & terminations, and project status tracking.
Assists personnel in the research department on study related activities, as required.
Complies with institutional and departmental policies and procedures.
Participates in multidisciplinary quality and service improvement teams as appropriate. Participates in meetings, serves on committees and represents the department and hospital/facility in community outreach efforts as appropriate.
Performs other duties as assigned.
Consistently demonstrates support for compliance in the performance of job duties and responsibilities by a) developing and maintaining knowledge of, and performing job functions in compliance with, rules, regulations, policies, and statutes that affect his/her job; b) maintaining knowledge of and performing job functions in compliance with MedStar Health and MedStar Health Research Institute policies and procedures; and c) reporting compliance concerns in an appropriate and timely manner.