Clinical Research Coordinator II

Job Description:

VALLEY MEDICAL CENTER

Job Description

(Unit/Clinic/Department Name)

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 Center

RESPONSIBLE TO: Manager - Valley Medical Center Clinical Research Center

PREREQUISITES:

• Four year degree preferred, national certification a plus.

• Phlebotomy License preferred

QUALIFICATIONS:

• Minimum 2 years 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.

• Administer diagnostic tests 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,

• Develops and 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 IRB and sponsor submissions, annual reviews, amendments and study closure.

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

• Fulfill all reporting obligations to sponsors and CROs

• Ensures center activities are in compliance with federal regulations, Good Clinical Practice guideline and center policies.

• 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 12/24

Grade: NC07

FLSA: NE

Job Qualifications:

PREREQUISITES:

• Four year degree preferred, national certification a plus.

• Phlebotomy License preferred

QUALIFICATIONS:

• Minimum 2 years 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