Job Ref: 24687
Talent Area: Research - Clinical
Houston Methodist Hospital
Houston, TX 77030
Area/Department: Structural Heart Dis_Interv
Employment Type: Regular
Job Type: Full-Time
Organization: Houston Methodist
Work Shift: DAY
Work Week: M - F
Houston Methodist Research Institute was formed in 2004 to rapidly and efficiently translate discoveries made in the laboratory and the clinic into new diagnostics, therapies and treatments. The research institute was created to provide the infrastructure and support for these endeavors, and to house the technology and resources needed to make innovative breakthroughs in important areas of human disease. A 540,000 square foot building dedicated to research, the research institute houses over 1,500 staff and trainees, 277 principal investigators and has more than 840 ongoing clinical trials.
The Senior Clinical Research Coordinator may manage multiple clinical research projects and/or for multiple Principal Investigators, gathering patient data via methods specified in the study protocol and providing general administrative duties in support of the study.
DUTIES AND RESPONSIBILITIES:
1. Attends and participates in the Investigator meeting.
2. Reviews goals and requirements of any new protocols and coordinates study initiation.
3. Supervises preparation of all IRB and Regulatory Documents; under direction of PI may draft various communications with Sponsor.
4. Assesses staffing needs based upon current research activity and implements changes in staffing as needed.
5. Participates in pre-site and site initiation visits.
6. Plans and designs source documentation for protocol.
7. Develops assessment tool per protocol to use in clinical research and teaches research team how to use the assessment tool.
8. Develops procedures for laboratory collection and storage.
9. Identifies and recruits clinical research subjects; monitors enrollment goals and modifies recruitment strategies, as necessary; mentors all clinical research personnel regarding enrollment/recruitment.
10. May assist PI in obtaining Informed Consent process from study participant and documents appropriately.
11. Completes an initial patient assessment utilizing interview, observation, and examination; obtains Vital Signs and performs phlebotomy; teaches proper procedures to research coordinator and research coordinator assistant.
12. Identifies the patient at risk, psychologically, and physiologically.
13. Monitors participants labs and notifies the PI of laboratory findings.
14. 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.
15. Conducts reviews of on-going studies and oversees quality assurance on ongoing protocols; productive working relationship with the study monitor.
16.Conducts in-service to floor nurses/ physicians.
17. Precepts new clinical research staff and educates research staff regarding scientific aspects of studies.
18. Serves as a role model and resource for the clinical research staff.
19. Provides performance management for staff under direction of PI.
20. Assesses communication process within Department and/or services required by the protocol.
21. Elicits relevant data from sources outside of the hospital.
22. Assists PI in budget development; may monitor ledgers.
23. Assists in processing and shipping lab specimens efficiently and cost effectively; maintains supply inventory and equipment; ensures retirement of test article / clinical supplies; maintains regulatory standards.
24. Adheres to internal controls established for department.
25. Demonstrates the components of the ICARE values statement.
26. Follows all safety rules while on the job. Reports accidents promptly and corrects minor safety hazards. Completes all hospital required and job-related in-services and applies the information needed.
27. Performs other duties as assigned.
Bachelor`s degree in Basic Science required. Masters degree preferred.
5 plus years clinical research experience..
CERTIFICATES, LICENSES AND REGISTRATIONS REQUIRED:
CCRC and CCRP Preferred
SPECIAL KNOWLEGE, SKILLS AND ABILITIES REQUIRED:
WORKING : Standard laboratory environment; some assignments may be in hospital units with typical hospital environmental hazards and concerns.
Houston Methodist is an Equal Opportunity Employer.
Equal employment opportunity is a sound and just concept to which Houston Methodist is firmly bound. Houston Methodist will not engage in discrimination against or harassment of any person employed or seeking employment with Houston Methodist on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, status as a protected veteran or other characteristics protected by law.
VEVRAA Federal Contractor – priority referral Protected Veterans requested.