Clinical Research Coordinator

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Please note, the functions below are representative of major duties that are typically associated with these positions. Specific responsibilities may vary based upon departmental needs. Similarly, not all duties that have been outlined will be assigned to each position.

Responsible for oversight of defined clinical protocols: advertise the recruitment of study subjects/volunteers, interview/screen them for study eligibility, schedule appointments with various hospital departments, review test results with the PI/study nurse practitioner to ensure that protocol requirements are met and that abnormalities are addressed, collect data from various sources and input them into data collection/analysis systems, and coordinate feedback of study flow and results to principal investigators. The Coordinator will complete applications/forms/reports and submit them in a timely manner to various research bodies like the Institutional Review Board (IRB), the Translational and Clinical Research Center (TCRC),and the NIH.

Specific Duties:

• Develop and implement strategies to recruit volunteers to participate in clinical trials.
• Interview (prescreen) prospective volunteers and/or their parent/guardians and determine their eligibility to participate in the clinical trial
• Schedule and conduct study visits with volunteers, including assessments such as conducting interviews, administering computerized questionnaires and tasks, assessing MRI eligibility, operating the MRI scanner and collecting fMRI data, collecting biological samples (e.g., pregnancy tests, blood draws, vital signs, hair samples), processing/centrifugating blood samples. Training provided.
• Conduct structured clinical interviews for psychiatric disorders, including eating disorders, mood disorders, and suicidal ideation. Training and supervision with clinical psychologist provided.
• Enter and maintain all data collected from participants in subject charts, regulatory binders, and study databases.
• Enter and maintain all data collected from participants in subject charts, regulatory binders, and study databases.
• Complete administrative tasks such as order study supplies, schedule study appointments, process subject reimbursement
• Complete applications/forms/reports and submit them in a timely manner to various research bodies like the Institutional Review Board (IRB), the Translational and Clinical Research Center (TCRC), and the NIH.
• Serve as a primary contact for urgent clinical research matters.
• Able to work on-site during normal business hours with the flexibility to attend study visits that may occur during early mornings, evenings, and (rarely) weekends.
• Full-time, 2-year position.

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:

• Careful attention to details and outstanding organizational skills
• Strong interpersonal skills and ability to demonstrate respect and professionalism for subjects' rights and individual needs.
• Excellent written and verbal communication skills.
• Ability to manage multiple responsibilities simultaneously and shift priorities as needed.
• Ability to work independently and as a team player.
• Working knowledge of clinical research protocols.
• Flexibility in working on different studies depending on program needs.
• Analytical skills and ability to anticipate, identify, and present solutions to resolve problems.
• Ability to interpret acceptability of data results.
• Computer literacy including the use of Microsoft Office.
• Working knowledge of electronic data capture systems.

QUALIFICATIONS

Education:

Bachelor's degree required.

Experience:

New graduates with some relevant course/project work or those without any prior research experience will be considered for the Clinical Research Coordinator I position outlined above.

Those with a minimum of 1-2 years of directly related work experience will be considered for a Clinical Research Coordinator II position.

Supervisory Responsibility (if applicable):

A Clinical Research Coordinator I does not have any supervisory responsibility.

A Clinical Research Coordinator II may assist with the training and orientation of new staff members.