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Company: The Woman's Hospital of Texas- Houston
Location: Houston, TX
Career Level: Entry Level
Industries: Healthcare, Pharmaceutical, Biotech

Description

Description

SHIFT: No Weekends

SCHEDULE: Full-time

The Woman's Hospital of Texas – Houston, TX

Clinical Research Coordinator

The Woman's Hospital of Texas opened in 1976 and ever since has remained the state's premier facility dedicated solely to the health of women and newborn infants.

Located near the Texas Medical Center, Woman's offers 397 licensed beds, including a NICU (neonatal intensive care unit) and a full range of women's health services and newborn infants.

More than 650 board-certified physicians at Woman's offer their expertise and an outstanding level of quality care in the areas of gynecology, obstetrical care, high-risk pregnancy and minimally invasive surgery.

The Woman's Hospital of Texas is currently looking for a Clinical Research Coordinator.


Responsibilities:

1. Under the supervision of the Research Center Director and nurse practitioner, responsible and held accountable for all job-related activities.

2. Serves as primary study coordinator for research protocols in the outpatient clinic or at affiliated hospital as assigned by the Director.

3. Directs the conduct of clinical studies to ensure adherence to the research protocol.

4. Screens patient records, databases and physician referrals for identification of prospective candidates for research protocols.

5. Interviews prospective subjects and assure qualifications for participation in clinical trials and obtains informed consent.

6. Participates in all assigned study related visits/meetings(investigator meetings may require travel) and implements the assigned clinical trials according to mutually agreed upon timelines by PI and Sponsor.

7. Educates subjects for elective participation in our clinical trials.

8. Educates clinic/hospital personnel on assigned clinical trials in protocol conduct, data collection process and related issues as applicable.

9. Ensures all study related personnel have completed required training and training is documented, before conducting any protocol related activities.

10. Actively recruits and exceeds enrollment goals in assigned clinical trials and provides monthly, written documentation of screening/enrollment/follow-up activities.

11. Coordinates the collection of data according to the research protocol, operation manual and case report form guidelines within the budgetary guidelines established by the Director.

12. Draws, prepares and ships laboratory samples for clinical trials.

13. Maintains investigational drug/device dispensing accountability and shipping logs according to protocol guidelines.

14. Instructs Principal Investigator on procedures and tests that need to be performed in compliance with the study protocol and advises PI on the results of procedures and testing; calling to attention findings of clinical importance in a timely manner.

15. Documents research related examinations, procedures, tests and other activities in appropriate clinic or hospital charts.

16. Documents phone conversations with sponsors, study subjects, physicians, coordinating organizations, and any other pertinent resources and place in appropriate source.

17. Schedules follow-up visits/procedures for study subjects and provides source documentation for activities conducted during these visits.

18. Completes accurate and complete data entry into case report forms or pre-established computer programmed formats in a timely manner.

19. Coordinates, schedules and is made available for assigned study monitor visits, quality assurance audits, and query resolution of collected data in a timely manner.

20. Identifies strategies for patient enrollment in research studies in collaboration with the PI.

21. Report all serious or unexpected adverse events immediately to PI and Research Director.

22. Assist in reporting all serious or unexpected adverse events to appropriate regulatory agencies (sponsor, IRB) in a timely manner.

23. Assists in maintenance of research related logs and contact data base.

24. Maintains up to date research knowledge through continuing education.

25. Actively promotes an open line of communication and a professional relationship with all members of the organization.

26. Utilizes appropriate resources to resolve problems. Report any unresolved issues to Director.

27. Possess the ability to prioritize and organize high volume workload and flexible with changing priorities to fit the daily needs of the department, patients and customers we serve.

28. Knowledgeable of, and adheres to all local, state, and federal research regulations and guidelines.

29. Performs any other duties as assigned.


Qualifications

JOB REQUIREMENTS:

BSN, required

Licensure/Certification:

Certified Research Coordinator, preferred

Experience required or preferred:

Minimum of one year experience in a clinical setting, required

Women's Services Clinical Research experience, STRONGLY preferred

Notice

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