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Regulatory Compliance Specialist

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POST DATE 8/11/2016
END DATE 10/19/2016

Methodist Houston, TX

Company
Methodist
Location
Houston, TX
AJE Ref #
575846728
Job Classification
Full Time
Job Type
Regular
Company Ref #
25895
Experience
Entry Level (0 - 2 years)
Education
Bachelors Degree

JOB DESCRIPTION

Job Summary

Perform study specific regulatory and safety reporting processes across multiple studies in accordance to appropriate regulations, Standard Operating Procedures (SOPs), and study specific protocols/plans and process under the direction of the Regulatory Compliance Manager.

DUTIES AND RESPONSIBILITIES:

1. Assure compliance of general and study-specific regulatory and/or safety related processes with SOP`s, 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, notifies IRB of study closures.

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

4. Work closely with the sponsor and study personnel on relevant regulatory and/or safety issues.

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.

8. Maintain regulatory files for monitoring visits and interact with monitors.

9. Maintain archived documents on and off site.

10. May interface with appropriate governmental agency on project/products as identified by the Manager.

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

12. Displays ICARE values.

13. Perform other duties as assigned.

EDUCATION REQUIREMENTS:

Bachelor Degree or 30 hours college coursework preferred.

EXPERIENCE REQUIREMENTS:

1 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 :

Office and clinic environment. Travel not required.
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.

Overview

At Houston Methodist, Leading Medicine is more than a description of what we do; it's who we are. We take our responsibility as Houston's premier health care system seriously, and with a national reputation for excellence in patient care, innovation and research, we hold ourselves and the careers we build to a higher standard. Our culture is diverse, dynamic and challenging. We believe in our I Care Values and conduct ourselves with Integrity, Compassion, Accountability, Respect for others and a commitment to Excellence. Discover the difference for yourself and join Houston Methodist.

Company Size:
5,001-10,000 Employees
Industry
Health Care
Founded:
1919
Social Media:
Headquarters:
8100 Greenbriar
Houston, TX 77030

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