Research Study Coordinator - Department of Medicine, Division of Metabolism, Endocrinology and Nutrition

Job Description

Reporting to the Research Coordinator Supervisor and the Medical Director, the Research Study Coordinator is responsible for developing and maintaining ongoing support for clinical studies within the unit. The Research Study Coordinator will follow research protocols to obtain data through interviewing subjects/patients, conducting laboratory tests, following research protocols, coordinate patient participation in medical research studies and compile and verify the accuracy of research data.

The Diabetes Institute Clinical Research Unit is a research facility dedicated to the conduct of human studies of diabetes and related disorders. We provide a variety of study support services including facility and room use, research coordinator support, research nursing or midlevel provider support, blood draws, clamp services, and performance of body composition by DXA.

• Under general supervision, coordinate the operations of clinical, biomedical, and/or behavioral research studies involving human subjects
• Coordinate study startup activities and communications with sponsors, local and central IRBs, and other key stakeholders. Support study budget development and negotiation, regulatory submissions, and completion of required startup documentation and approvals
• Coordinate specialized tasks with the research team such as the operation of equipment, processing of laboratory specimens, administering of treatment and/or medication in accordance with research protocol, assessment of patient reaction to medications and/or treatments as part of a research protocol and identification of potential adverse reactions.
• Perform certain non-invasive patient oriented procedures (eg DXA, EKG, anthropometric measurements)
• Responsible for the processing and shipping of study-specific laboratory specimens;
• Coordinate physician examinations and study protocol for technicians;
• Keep study files in compliance with Food and Drug Administration's regulations;
• Read, interpret and communicate protocol for clinical studies providing data on the safety and efficacy of new drugs;
• Establish and maintain effective working relationships with patients and their families, professional or community groups and volunteers;
• Maintain contact with Principal Investigators, Co-Investigators, and public agencies which are involved with aspects of the research
• Assist Research Coordinator Supervisor with assigned administrative tasks related to study maintenance

• Maintain records of study data;
• Design data collection tools;
• Obtain and record research data in conjunction with physician and other professionals on the research team;
• Assist in preparing interim reports for Principal Investigators, Study Sponsor and Human Subjects Review Board to ensure that each project timeline is being met;
• Communicate with Principal Investigators, pharmaceutical and equipment company medical personnel in handling results of studies (progress reports, case report forms)

• Screen, recruit and interview potential subjects to determine eligibility according to specific study protocols.
• Obtain informed consent;
• Enroll patients in research protocol;
• Explain research protocol to participants;
• Respond to patient inquiries regarding protocol;
• Schedule patient participation;
• Coordinate all aspects of the patient's care;
• Ensure compliance with research protocol;
• Inform referring physicians of protocol requirements;
• Perform other duties as assigned, including supporting CRU activities and related operational tasks.

To be considered for this opportunity your application must demonstrate you meet both the minimum qualifications and additional qualifications listed below. Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration.

• Two years of college level course work in a relevant academic area AND two years of experience performing work in support of clinical, biomedical, or behavioral research studies involving human subject.
• Equivalent education and/or experience may substitute for minimum qualifications…