Coordinator Clinical Research Senior, Center for OCR - Galveston jobs in United States
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The University of Texas Medical Branch · 1 month ago

Coordinator Clinical Research Senior, Center for OCR - Galveston

The University of Texas Medical Branch is a leading healthcare institution, and they are seeking a Senior Clinical Research Coordinator to manage clinical research projects for Principal Investigators. The role involves gathering patient data, ensuring compliance with regulations, and providing administrative support for clinical studies.

Responsibilities

Applies knowledge in contributing to Good Clinical Practice (GCP) activities and/or other regulatory activities
Under the direction of the PI, supervises and assists with the preparation and submission of all IRB and Regulatory Documents to obtain final approval and may draft various communications with Sponsor
Attends and participates in the Investigator meeting
Reviews goals and requirements of any new protocols and coordinates study initiation
Identifies and recruits clinical research subjects for participation of studies, collects data, and monitors enrollment goals
Assesses staffing needs based upon current research activity and implements changes in staffing as needed
Participates in protocol initiation visits
Plans and designs source documentation for protocol
Develops assessment tool per protocol to use in clinical research and teaches research team and hospital personnel how to use the assessment tool as allowed per medical practice
Develops 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
Maintains accurate source documentation and appropriate forms as per protocol including participant records, drug documentation, reconciling study drug accountability; monitors documentation for quality and accuracy
Conducts reviews of on-going studies and oversees quality assurance on ongoing protocols; productive working relationship with the study monitor
Precepts new clinical research staff and educates research staff regarding scientific aspects of studies
Provides performance management for staff under direction of PI
Assesses communication process within Department and/or services required by the protocol
Elicits relevant data from sources outside of the hospital
Assists PI in budget development; may monitor ledgers
Assists in processing and shipping lab specimens efficiently and cost effectively; maintains supply inventory and equipment; ensures return of test article /clinical supplies; maintains regulatory standards
Identifies and recruits clinical research subjects; monitors enrollment goals and modifies recruitment strategies, as necessary; mentors all clinical research personnel regarding enrollment/recruitment
Monitors participants labs and notifies the PI of laboratory findings
Serves as a role model and resource for the clinical research staff
May assist PI in obtaining Informed Consent from study participant and documents appropriately. Adheres to internal controls established for department

Qualification

Clinical research coordinationClinical Practice (GCP)IRB submissionData collectionStaff supervision

Required

Bachelor's degree and five years experience as clinical research coordinator or equivalent experience

Preferred

Previous clinical research experience

Company

The University of Texas Medical Branch

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The University of Texas Medical Branch is a component of the University of Texas System located in Galveston, Texas

H1B Sponsorship

The University of Texas Medical Branch has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (73)
2024 (66)
2023 (52)
2022 (57)
2021 (49)
2020 (50)

Funding

Current Stage
Late Stage
Total Funding
$35M
Key Investors
National Institute of Allergy and Infectious Diseases
2024-09-13Grant
2019-04-09Grant· $35M

Leadership Team

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Donna Sollenberger
EVP and CEO, Health System
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Company data provided by crunchbase