JOB TITLE: Clinical Research Coordinator

JOB CLASSIFICATION: Full Time Overtime Exempt

GENERAL SUMMARY OF DUTIES: The Clinical Research Coordinator is responsible for the daily management of the clinical trial activities. The CRC must be self-directed, able to function independently, and have an in depth understanding of the study protocol(s). The CRC is responsible for coordinating and conducting all aspects of the clinical study and the communication with the Principal Investigator(s).

SUPERVISION RECEIVED: Reports directly to Administrator.

SUPERVISION EXERCISED: None

TYPICAL PHYSICAL DEMANDS: Requires sitting for periods of time. Working in clinical office environment. Some bending, stretching, and light lifting required. Working under moderate stress and use of telephone required. Manual dexterity required for use of computer keyboard.

TYPICAL WORKING CONDITIONS: Normal office environment. Occasional evening or weekend work, including travel to Sponsor investigator meetings.

EXAMPLES OF DUTIES: (May not include all of the duties assigned)

Ensures that clinical research and related activities are performed in accordance with Federal Regulatory guidelines and sponsoring agency policies and procedures.

Collaborates with PI to prepare IRB and any other regulatory submission documents as required by protocol

Develops all required materials and tools necessary to perform the clinical study; informed consent, CRF’s, enrollment logs, drug accountability logs, protocol requirements, schedule of visits, regulatory binders, execution of research plan and maintains all required documentation.

Maintains compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to appropriate persons.

Provides study participants with information concerning the study drug, protocol requirements, and medical testing requirements; evaluates their understanding of and potential compliance with the study protocol.

Consults with patient and physicians to facilitate continuous monitoring of all participants’ health status and to keep abreast of changes in patient health status.

Collaborates with Study Investigators and Manager of Clinical Trials to anticipate potential problems and solve current problems involving study participants.

Serves as a resource person to study participants, Study Investigators, office staff & hospital staff.

Reports all activities concerning the clinical aspect of the study to the Manager of Clinical Trials and the Pharmaceutical Monitor in a timely, accurate and ethical manner.

Recruits and schedules patients for study procedures and physicians’ office visits in accordance with the appropriate protocol’s time line.

Maintains ethical aspects of the study at all times when dealing with study participants, physicians pharmaceutical companies and sponsors.

Dispenses study drug and accounts for study drug when it is returned by study participants.

Assists in all aspects to close out project as prescribed by CRO/Sponsor.

Enters all charges on a daily basis for visits and other approved budgetary items.

Performs other tasks as required.

PERFORMANCE REQUIREMENTS:

Knowledge, Skills & Abilities: Previous research experience, lab specimen collecting and processing, phlebotomy, ECG testing, organization of files, patient calendar visits, attention to detail, high energy with determination to achieve desired results of company and clinical study sponsor. Excellent communication skills; oral and written. Honest, self-starter requires little direction to achieve desired results.

Education: Nationally recognized coordinator certification, LPN or Associate Degree.

Experience: direct management and oversight of clinical drug studies is required.

Certificate/License: CRC

ALTERNATE TO MINIMUM QUALIFICATIONS: background in Health Sciences, Biotechnology or Pharmaceutical industry