Coordinator, Clinical Research Obstetrics and Gynecology Research Support Unit - (Galveston/Spanish)

University of Texas Medical Branch (UTMB)•Galveston, TX

About The Position

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.

Requirements

Bachelor's degree or equivalent
Two years of directly related experience

Nice To Haves

ACRP or SOCRA Certification
Bilingual (Spanish)

Responsibilities

Obtain human subject data for clinical research activities via methods specified in the study protocol and performs general administrative duties supporting the study.
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.
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.
Applies knowledge in contributing to Good Clinical Practice (GCP) activities and/or other regulatory activities.
Reconciles study drug accountability; maintains temperature and QC logs per protocol compliance.
Adheres to internal controls and reporting structure.
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 meetings.
Performs related duties as required.