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JOB DETAILS

Senior Regulatory Compliance Specialist

Job Ref: 27421

Talent Area: Professional

Location:
Houston Methodist Hospital
Houston, TX 77030

Area/Department: Cancer Clinical Trials

Employment Type: Regular

Job Type: Full-Time

Organization: Houston Methodist

Work Shift: DAY

Work Week: M - F


Company Profile

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.


Job Summary

Lead, coordinate and perform study specific regulatory processes across multiple studies of different therapeutic areas and phases in accordance to appropriate regulations, Standard Operating Procedures (SOPs), and study specific protocols/plans and processes under the with minimal supervision from the Regulatory Compliance Manager. Lead team in problem solving issues of moderate to complex scope. Assist with internal departmental monitoring and research education as identified by the Regulatory Compliance Manager.  

DUTIES AND RESPONSIBILITIES: 

1. Assure compliance of general and study-specific regulatory and/or safety related processes with SOPs, FDA, GCP, NIH and applicable regulations.

2. Responsible for assisting in the preparation of research protocols for IRB submission, submitting protocol amendments, preparing renewals, preparing necessary regulatory documents for submission to study sponsors, submits adverse event reports, submits safety reports, and notifies IRB of study closures.

3. Perform high quality clinical review of regulatory forms and associated documentation (during internal monitoring or review of trials). 

4. Build and maintain effective relationships with key study personnel.

5. Provide routine updates and reporting to the Regulatory Compliance Manager to ensure timely communication regarding status of regulatory and/or important safety related issues.

6. Act as a liaison between the institutional review committees, regulatory agencies, and the investigators to ensure that protocols are approved and that supplementary information is provided in a timely fashion as requested.

7. Maintain the required regulatory files for all clinical trials to ensure regulatory compliance. Meet with study monitors. Maintain archived documents on and off site.          

8. Prepare and manage FDA documents required to initiate investigational drugs trials. 

9. May interface with appropriate governmental agency on project/products as identified by the Manager. Assist in the preparation of periodic reports for FDA. 

10. Maintain a professional and credible image with FDA and other regulatory agencies, sponsors, vendors, patients and co-workers.         

11. Develop appropriate regulatory reports and associated documentation in accordance with SOPs and study specific processes under the direct supervision of the Regulatory Compliance Manager.   

12. Assist in training regulatory personnel and others on regulatory and safety reporting regulations, processes, and procedures under the direct supervision of the Regulatory Compliance Manager (serves as a resource for regulatory information and guidance).

13. Maintains accountability for own ongoing professional growth and development.

14. Displays ICARE values.

15. Perform other duties as assigned.  

 

EDUCATION REQUIREMENTS:

Bachelors Degree preferred. May substitute some years of relevant experience with relevant graduate or advanced degree. 

 

EXPERIENCE REQUIREMENTS:

5   year relevant research program experience. 

 

CERTIFICATES, LICENSES AND REGISTRATIONS REQUIRED: 

Regulatory Affairs Professionals Society (RAPS), Certified Clinical Research Counselor (CCRC), or Certified Clinical Research Professional (CCRP) is required.

 

WORKING :

Normal office conditions and contact with inpatients and outpatients. Ability to walk, stand, climb stairs, and sit for lengths of time.


Equal Employment Opportunity

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.