GENERAL SUMMARY/OVERVIEW STATEMENT:
The Clinical Research Coordinator is an integral member of an interdisciplinary research team which supports the study of patients with feeding and eating disorders and healthy controls within a clinical investigational setting, in collaboration with the Neuroendocrine Unit (Department of Medicine) and Eating Disorders Clinical and Research Program (Department of Psychiatry). Specifically, the Clinical Research Coordinator supports a study investigating the neurobiology of adults with avoidant/restrictive food intake disorder (ARFID). Under general supervision of the Principal Investigators and/or Nurse Practitioner, the incumbent carries out a broad range of research activities and procedures, as indicated below.
PRIMARY DUTIES AND RESPONSIBILITIES:
- * Develop and implement strategies to recruit volunteers to participate in clinical trials.
- * Interview (prescreen) prospective volunteers and determine their eligibility to participate in the study.
- * Conduct screening visits with volunteers, which includes administering and scoring the Structured Clinical Interview for DSM-5 [SCID-5], conducting computerized questionnaires and tasks, assessing MRI eligibility, and administering pregnancy tests.
- * Conduct main study visits with volunteers, which includes operating the MRI scanner and collecting fMRI data, processing/centrifugating blood samples, measuring vital signs, height, and weight, administering a breakfast meal, conducting and scoring the Pica, ARFID, and Rumination Disorder Interview [PARDI] and various questionnaires, measuring hand grip strength using a hand dynamometer, and collecting hair samples.
- * Enter and maintain all data collected from participants in subject charts, regulatory binders, and study databases.
- * Review test results with the PIs/study nurse to ensure that protocol requirements are met and that abnormalities are addressed.
- * Order study supplies, schedule study appointments, process subject reimbursement checks.
- * Complete applications/forms/reports and submit them in a timely manner to various research bodies like the Institutional Review Board (IRB), the Research Pharmacy, the Clinical Research Center (CRC), and the NIH.
- * Preprocess MRI data using Linux terminal and SPM.
- * Serve as an on-call contact for urgent clinical research matters.
- * Hours include early mornings, evenings, and (rarely) weekends/holidays.
ADDITIONAL DUTIES AND RESPONSIBILITIES:
- * Act as study resource for subjects.
- * Perform study procedures such as phlebotomy, EKG, etc. (training provided).
- * Create agenda for weekly clinical research meetings with staff and PIs; be prepared to report on study progress.
- * General clerical tasks (file, photocopy etc.).
- * Create supplies kits for the collection of biological samples (e.g., stool collection kit).
- * Work in -80C freezers (specimen storage); ship a variety of human biological samples on dry ice.
- * Create and maintain a variety of study logs, including billing logs.
- * Use software programs to generate statistical graphs and reports.
- * Communicate with clinicians, study volunteers, etc., using HIPAA guidelines.
- * Assist with formal audits of data and study documents.
- * Assist with creating consent forms and other study-related documents.
- * Recommend protocol changes and assist with preparing abstracts and posters.
- * Help organize research lab meetings.
SKILLS/ABILITIES/COMPETENCIES REQUIRED:
- * Proficiency in R programming language and data cleaning.
- * Prior experience conducting MRI scans (preferred but not required).
- * Careful attention to details.
- * Outstanding organizational skills.
- * Ability to follow directions.
- * Strong communication skills.
- * Computer literacy.
- * Working knowledge of clinical research protocols.
- * Ability to demonstrate respect and professionalism for subjects' rights and individual needs.
The Clinical Research Coordinator II should also possess:
- * Ability to work independently and as a team player.
- * Analytical skills and ability to resolve technical problems.
- * Ability to interpret acceptability of data results.
- * Working knowledge of data management programs such as REDCap.
SUPERVISORY RESPONSIBILITY:
- * A Clinical Research Coordinator I or II may assist with hiring, supervising, and mentoring clinical research interns.
- * A Clinical Research Coordinator II may assist with the training and orientation of new staff members.