Clinical Research Coordinator, Sealy Center on Aging
1 month ago
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
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