Sr. Clinical Research Coordinator, Research Administration
The Senior Clinical Research Coordinator manages clinical research projects for Principal Investigators by gathering patient data via methods specified in the study protocol. Provides complex administrative duties in support of the study to ensure compliance with regulations.
Bachelor’s degree and five years’ experience as clinical research coordinator or equivalent experience.
Specific Job Related Duties:
- 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.
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.