Job Information
UTMB Health Clinical Research Coordinator, Sealy Center on Aging (Partial Remote) in Galveston, Texas
Clinical Research Coordinator, Sealy Center on Aging (Partial Remote)
Galveston, Texas, United States
New
Clerical & Administrative Support
UTMB Health
Requisition # 2402330
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.
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.
Conducts behavioral intervention visits in the clinic setting.
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.
Work with research databases to collect milestone research visits and develop reports. RED Cap database knowledge a plus.
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
Knowledgeable of IRB practices e.g., submitting a protocol amendment, protocol deviation, and continuing review.
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 data collection and storage.
Assists in processing and sharing data per data use agreements or if indicated asper regulations.Experience working with outside reporting agencies such as CROMS orclinicaltrials.gov a plus.
Assists in precepting new clinical research staff and educating other research staff regarding scientific aspects of studies.
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.
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.
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 VEVRAA Federal Contractor, UTMB Health takes affirmative action to hire and advance women, minorities, protected veterans and individuals with disabilities.
Compensation