Job Description:

TITLE: Clinical Research Coordinator

JOB OVERVIEW: Clinical Research Coordinators manage clinical studies and site personnel from pre-study planning to successful completion.

ROLE: Clinical support

AREA OF ASSIGNMENT: Valley Medical Center Clinical Research

RESPONSIBLE TO: Administrative Director Cancer Services

PREREQUISITES:

• Four year degree preferred, national certification a plus.

• Phlebotomy License preferred

QUALIFICATIONS:

• Minimum 1 year of experience in a clinical research environment.

• Must have a working knowledge and be skilled in the use of personal computers, information storage and retrieval systems.

• Candidates must be highly organized, utilize excellent verbal and written communication and able to multi-task

UNIQUE PHYSICAL/MENTAL DEMANDS, ENVIRONMENT, AND WORKING CONDITIONS:

PERFORMANCE RESPONSIBILITIES

A. Generic Job Functions:

Clinical Research Coordinator responsibilities include but are not limited to:

• Participates in evaluation of new protocols. Maintains/updates all SOP's and supporting procedures.

• Pre-screening, screening, recruiting and enrolling patients. Scheduling and retaining patients.

• Coordinate with patient financial services to assure billing compliance for all billable research services

• Coordinate with Health Information Management to assure appropriate identification of research protocol participants in the electronic health record.

• Administer or coordinate results of diagnostic testing as required by sponsor protocol.

• Data collection and documentation. Collecting and recording adverse events and concomitant medications. Processing Serious Adverse Events. Study drug administration and accountability. All data entry, whether electronic data capture or on paper. Schedule monitor visits, meet with monitors, etc,

• Maintains a system for processing/tracking/filing all protocol-related regulatory documentation and study contracts/budgets.

• Attend investigator meetings

• Source document development

• Prepares/completes/complies all forms and documentation for OHRP Federal Wide Assurance and otherwise ensures that center activities are in compliance with federal regulations, Good Clinical Practice guideline and all applicable UW and VMC policies.

• Assures appropriate IRB approval for all studies prior to submission to Clinical Research Clinical Oversight Committee (RCOC) and sponsor submissions, annual reviews, amendments and study closure.

• Tracking/submission/filing of all safety reports/adverse events/protocol deviations to sponsors and RCOC.

• Fulfill all reporting obligations to sponsors and RCOC

• Management of all miscellaneous tasks involved with coordinating clinical trials

• Obtain IATA certification

B. Unique Job Functions:

• Conducts in-service/ training for center staff as needed.

• Performs other related job duties as required.

Revised 1/02, 1,08, 1/09, 2/10, 10/14

Job Qualifications:

PREREQUISITES:

• Four year degree preferred, national certification a plus.

• Phlebotomy License preferred

QUALIFICATIONS:

• Minimum 1 year of experience in a clinical research environment.

• Must have a working knowledge and be skilled in the use of personal computers, information storage and retrieval systems.

• Candidates must be highly organized, utilize excellent verbal and written communication and able to multi-task