- 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.
- 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.
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Clinical Research Coordinator, Sealy Center on Aging - Galveston, United States - UTMB Health
Description
Clinical Research Coordinator, Sealy Center on Aging (Partial Remote)Galveston, Texas, United States
New
Clerical & Administrative Support
UTMB Health
Requisition #
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:
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
