Clinical Research Coordinator - Neuroendocrine Unit (job # 3189111)
GENERAL SUMMARY/ OVERVIEW STATEMENT:
The Clinical Research Coordinator is an integral member of an interdisciplinary team which supports the study of patients and normal volunteers within a clinical investigational setting in the Neuroendocrine Unit. Under general supervision of the Principal Investigator and/or Nurse Practitioner, the incumbent will carry out a broad range of research activities and procedures as indicated below.
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 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 Research Pharmacy, the Clinical Research Center (CRC), the NIH and the FDA.
- Specific Duties:
- Work closely with the study nurse and PI to conduct the study with subject safety and data integrity as the priorities.
- General clerical tasks (file, photocopy etc.)
- Order study supplies, schedules study appointments, process subject reimbursement checks
- Develop and implement strategies to recruit volunteers to participate in clinical trials
- Interview (prescreen) prospective volunteers and determine their eligibility to participate in the clinical trial
- Escort subjects to and from appointments located in different hospital departments
- Perform study procedures such as phlebotomy, EKG, Holter monitoring, etc. (training provided)
- Act as study resource for subjects
- Work with human tissue (i.e. blood, fat etc.) using Standard Precautions
- Work in -80°C freezers (specimen storage)
- Ship (FedEx) a variety of human tissue on dry ice
- Collect and organize subject data (i.e. medical records, lab reports, MRI/CT reports etc.)
- Create and maintain a variety of study logs, including billing logs
- Use software programs to generate statistical graphs and reports
- Maintain subject charts, regulatory binders and study databases
- Communicate with clinicians, study volunteers, etc., using HIPAA guidelines
- Assist with formal audits of data and study documents
- Communicate with the IRB and various other research regulatory bodies
- Assist in creating consent forms and other study related documents
- Administer/score study questionnaires
- Recommend protocol changes and assist with preparing abstracts and posters
- Create agenda for and attend weekly clinical research meetings with staff and PI, be prepared to report on study progress
- Assist with transfer, accountability, and destruction of investigational product, including controlled substances, under proper supervision of registered physician investigator/study nurse.
- Be open to rare weekend/evening hours in the case of an emergency (i.e. freezer malfunction requiring all stored specimens be relocated)
SKILLS/ABILITIES/COMPETENCIES REQUIRED:
- Careful attention to details
- Good organizational skills
- Ability to follow directions
- Good 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 program
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.