Job Description

The mission of The University of Texas M. D. Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees and the public.

The primary purpose of the Coordinator, Regulatory Compliance is to provide departmental administrative support, management interface, operational management for all protocols, and quality assurance expertise to ensure departmental compliance with regulatory accreditation agencies. This position will direct and plan special administrative assignments and programs; direct the preparation of reports and other documentation required for the department and/or programs. This position will also coordinate policy development, implementation and completion, the design, execution, and effectiveness of quality assurance programs.

Key Functions
* Direct activities that help to resolve operational and budget issues associated with grants and protocols as directed by the respective PIs and responsible personnel.

* Direct, coordinate and assist in achieving goals for area of responsibility and offer suggestions/recommendations regarding program operations with the goal of creating efficiencies.

* Engage in regulatory quality assurance on a day to day level by ensuring compliance with policies and procedures affecting the submissions review, approval, activation, regulation, tracking of protocols.

* Design, establish, and monitor progress of projects through the applicable database systems.

* Coordinate, compile and maintain project-specific status reports.

* Coordinate, create and maintain project timelines.

* Coordinate project meetings and produce quality minutes.

* Coordinate the preparation of regulatory documents in accordance with FDA guidelines and assists with quality assurance of all research protocols.

* Develop, monitor, and maintain material transfer agreements/data use agreements (MTAs/DUAs).

* Monitor protocol consents.

* Ensure appropriate documentation is in place prior to data distribution.

* Assist with the coordination of grant and contract proposals, including writing and preparing portions of applications, and editing, proofreading and collating proposals.

* Assist with preparation of annual resubmission and reports for appropriate agencies on an as needed basis

* Maintain working relationships with internal associates and external collaborators.

* Maintain and utilize strong interpersonal skills to communicate with a variety of healthcare individuals.

* Participate in conferences and serves on committees.

* Attend weekly/monthly research meetings as required.

* Enhance professional growth and development through in-service meetings and educational programs.

* Other duties as required to support the Department of Genomic Medicine.

Working Conditions

This position requires:

Working in Office Environment

______ No

___x___ Yes

Working in Patient Care Unit (e.g. Nursing unit; outpatient clinic)

___x___ No

______ Yes

Exposure to human/animal blood, body fluids, or tissues

___x___ No

______ Yes

Exposure to harmful chemicals

___x___ No

______ Yes

Exposure to radiation

____x__ No

______ Yes

Exposure to animals

___x___ No

______ Yes

Physical Demands

Indicate the time required to do each of the following physical demands:

Time Spent

Never

0%

Occasionally

1-33%

Frequently

34-66%

Continuously

67-100%

Standing

x

Walking

x

Sitting

x

Reaching

x

Lifting/Carrying

Up to 10 lbs.

10lbs to 50 lbs.

x

More than 50 lbs.

Pushing/Pulling

Up to 10 lbs.

10lbs to 50 lbs.

x

More than 50 lbs.

Use computer/keyboard

x

Education

Required: Bachelor's degree in Business Administration or healthcare discipline.

Preferred: Master's degree in Business Administration, Healthcare

Administration or Health Professions.

Experience: Eight years of professional experience to include three years of the following: policy development, quality assurance, regulatory compliance, strategic planning or similar directly related experience. With preferred degree, six years of required experience.

Preferred:Previous regulatory experience.

It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html

Additional Information

* Requisition ID: 137043
* Employment Status: Full-Time
* Employee Status: Regular
* FLSA: exempt and not eligible for overtime pay
* Work Week: Evening/Night, Weekends
* Fund Type: Soft
* Pivotal Position: Yes
* Minimum Salary: US Dollar (USD) 68,400
* Midpoint Salary: US Dollar (USD) 85,500
* Maximum Salary : US Dollar (USD) 102,600
* Science Jobs: No