Clinical Research Coordinator, Research Administration (Galveston)

• Galveston, Texas, United States
• Research Academic & Clinical UTMB Health Requisition # 2604481

• MINIMUM QUALIFICATIONS

• + Bachelor's degree or equivalent, and two years of directly related experience.

• 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.

• 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.

• 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. Compensation