Clinical Research Coordinator, Ob/Gyn Research Support Unit (Galveston)

Minimum Qualifications

• Bachelor's degree or equivalent
• Two years of directly related experience
• Preferred: Bilingual (Spanish/English)
• At least two (2) years of Medical Assistant experience
• Hands-on experience performing phlebotomy

Job Description

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.

Job Duties

• 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.
• Aids in 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.
• May assist PI and/or research nurse coordinator in the planning and design of source documents for protocol.
• Aids in developing procedures for laboratory collection and storage.
• Aids in processing and shipping lab specimens; retrieves and/or sends identified research specimens certified if indicated as per regulations.
• Aids 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.
• Aids in 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.
• Travel as needed to other clinics to administer consent to study participants, recruit participants or complete follow-up visits.
• May attend and participate in the Investigator meetings.
• Performs related duties as required.

Salary Range

Commensurate with experience

Equal Employment Opportunity

UTMB Health strives to provide equal opportunity employment without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, genetic information, disability, veteran status, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. As a Federal Contractor, UTMB Health takes affirmative action to hire and advance protected veterans and individuals with disabilities.

Primary Location

United States-Texas-Galveston

Work Locations

0587 - John W McCullough Bldg

Job Research

Academic & Clinical

Regular Shift

Standard