Coord Clinical Research (SIVS Operations Research - Galveston)

REQUIRED EDUCATION / EXPERIENCE:
Bachelor’s degree or equivalent, and two years of directly related experience.

JOB SUMMARY:
The Clinical Research Coordinator obtains human subject data for clinical research activities via 
methods specified in the study protocol and performs general administrative duties supporting 
the study.

ESSENTIAL JOB FUNCTIONS:
 Applies knowledge in contributing to Good Clinical Practice (GCP) activities and/or other 
regulatory activities.
 Schedules, coordinates, and participates in the pre-site visit and site initiation visits; 
coordinates study initiation.
 Maintains and monitors source documentation and appropriate forms as per protocol for 
quality and accuracy, including participant records; assists with the quality assurance 
process.
 Incorporates directions from other health care disciplines into clinical research protocols 
when reviewing patient eligibility; assists in eliciting relevant data from sources outside of 
the hospital.
 Reconciles study drug accountability; maintains temperature and QC logs per protocol 
compliance.
 Develops and maintains productive working relationship with the study monitor; attends 
and participates in campus coordinator workshops.
 Identifies and recruits clinical research subjects for participation of studies, collects data, 
and monitors enrollment goals.
 Mentors new clinical research coordinators and assistant clinical research coordinators..
 Assists with grant/protocol preparation and submission to IRB, OCR or OSP 
under direction of research coordinator under the direction of the PI and with answering 
IRB stipulations to obtain final approval; documents IRB approval and contract approval 
 Under direction of PI may draft various communications with Sponsor and/or regulatory 
documents to be sent to the Sponsor.
 May assist PI and/or research nurse coordinator in the planning and design of source 
documents for protocol.
 Assists in developing procedures for laboratory collection and storage.
 Assists in processing and shipping lab specimens; retrieves and/or sends identified 
research specimens certified if indicated as per regulations

Assists in precepting new clinical research staff and educating other research staff 
regarding scientific aspects of studies.
 Assists in processing and shipping lab specimens efficiently and cost effectively; 
maintains supply inventory and equipment; maintains regulatory standards.
 Assists with the budget development; may monitor ledgers.
 Adheres to internal controls established for department.
 May assist PI in obtaining Informed Consent from study participant and documents 
appropriately. 
 Adheres to internal controls and reporting structure.

MARGINAL OR PERIODIC JOB FUNCTIONS:
 If appropriately trained and tested for competency, obtains Vital Signs and performs 
phlebotomy; monitors participants’ labs and notifies the PI of laboratory findings
 May attend and participate in the Investigator meeting
 Performs related duties as required.

EQUIPMENT:
Standard office equipment.
WORKING ENVIRONMENT/LOCATION OF POSITION:
Standard hospital, clinical, laboratory and/or office environments. 

OTHER:
Specific job requirements or physical location of some positions allocated to this classification, 
may render this position security sensitive, and thereby subject to the provisions of Section 
51.215, Texas Education Code.

Salary Range:  The salary range $34,960 - $52,440