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Clinical Research Coordinator

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Classification Details

Classification Information

Classification Title Coordinator
Classification Code 37250
FLSA Exempt

Position Details

Position Information

Position Title Clinical Research Coordinator
Position Number 926710
CIP Code
FTE 1.0
Pay Grade 7
Department Internal Medicine - 31510
Expectations for All Employees:

East Tennessee State University pursues its mission based upon core values. An employee’s job performance must support and exhibit the university’s core values: PEOPLE come first, are treated with dignity and respect, and are encouraged to achieve their full potential; RELATIONSHIPS are built on honesty, integrity and trust; DIVERSITY of people and thought is respected; EXCELLENCE is achieved through teamwork, leadership, creativity, and a strong work ethic; EFFICIENCY is achieved through wise use of human and financial resources; and COMMITMENT to intellectual achievement is embraced.

Job Summary

Reports to the Co-Director of the Center of Excellence for Inflammation, Infectious Diseases and serves as the interface between basic researchers and clinicians by facilitating specimen accrual to multiple translational studies; recruits subjects from multiple studies, obtaining informed consent from subjects and clinical samples; collects and/or processes the samples for use in the basic laboratory setting; serves CIIDI members who desire a translational component to their research programs; and performs other related duties as assigned.

Knowledge, Skills and Abilities
  • Ability to demonstrate exceptional interpersonal skills to deal effectively with clinicians, patients, administrators, auxiliary personnel, and regulatory bodies.
  • Ability to effectively present information and respond to questions from physicians, staff, and patients.
  • Ability to handle multiple projects in parallel.
  • Ability to prioritize quickly and appropriately.
  • Ability to pay attention to detail.
  • Ability to demonstrate excellent organizational skills to independently manage workflow.
  • Ability to demonstrate excellent verbal and written communication skills.
  • Skills in phlebotomy as necessary.
  • Knowledge of good clinical practice, FDA, OHRP, and HIPAA policies.
  • Knowledge of research protocols, principles and procedures.
Required Qualifications

Bachelor’s degree in Biological Sciences or related field required; 1 year of experience in a clinical research setting required; OSHA Bloodborne Pathogens certification required; phlebotomy experience and/or certification required.

Preferred Qualifications
Physical Demands
Supervision Given and Received

Performs under general supervision. Determines own methods for performing assigned work.

Version Date September 2017

Job Duties

These are the job duties required of the position.

Description of Job Duty
  • Manages all aspects of clinical protocol enrollment.
  • Coordinates with the PIs and institution to ensure all clinical research activity conforms to Federal, State, and University/IRB/HIPAA regulations.
  • Obtains and processes human blood/tissue samples in accordance with appropriate clinical standards.
  • Maintains all documentation of clinical research subjects and their associated health information in accordance with the specific protocol requirements.
  • Prepares IRB submission materials as necessary.
  • Assesses inclusion/exclusion criteria for study enrollment.
  • Coordinates participants’ testing/samples with clinical care team.
  • Comprehends all study protocol.
  • Assists PI in any study modifications.
  • Interfaces with laboratory personnel to ensure proper sample delivery.
  • Collects any clinical data as required by the protocol.
  • Understands and utilizes HIPAA compliant procedures.
  • Processes laboratory samples as required.
Job Duty Type Essential
Description of Job Duty
  • Maintains study protocol documentation including proof of training for study personnel.
  • Interfaces with prospective PIs seeking transitional research support.
  • Performs other related duties as assigned.
Job Duty Type Secondary