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Regulatory Compliance Coordinator

Employer
University of Texas MD Anderson Cancer Center
Location
Houston, Texas
Salary
Competitive
Closing date
Jan 31, 2024

View more

Discipline
Other, Legal/Regulatory Affairs
Organization Type
Healthcare/Hospital

Job Details

The primary purpose of the Regulatory Compliance Coordinator is to provide departmental administrative support, management interface, operational management for clinical trials, 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. Under the guidance of the Scientific Project Director, this role will also facilitate aspects of project management initiated within the ProTcT Program that may include process implementation, management of team members, and administrative oversight.

Job Specific Competencies

Clinical Research:

* Develop strategic plans and initiatives to facilitate clinical research and ensure that research practices are within federal and state regulations, professional standards, institutional policies, and clinical practice guidelines.
* Manages the effective operation of multiple clinical research projects and assigns to appropriate staff activities related to initiation and conduct of clinical trials.
* Oversight of administrative processing to maintain compliance with internal SRC, IRB and IND needs as well as all requirements for external submissions to both private and federal programs and projects for Cell Therapy Studies, and Treatment Agreements.
* Oversee and coordinate cell product and tissue banking repository
* Reviews new concepts and protocols in development.

Management

* Facilitates T-cell therapy trial activities including site initiation visits, investigator meetings, implementation of clinical trials, drug accountability, regulatory compliance, quality assurance, electronic submission of patient data, development of patient recruitment materials.
* Identify needs and provide guidance with regard to the policies and procedures that are related to management and monitoring of patients on clinical trials, as delineated in the department training manual and presented at weekly training meetings.
* Develops, enhances and implements standard project management processes, tools and methodologies.
* Ensures projects are completed on schedule, within budget and in accordance with applicable quality standards.
* Lead team efforts to develop and review quality control programs to evaluate and enhance data- and procedure-driven regulatory activities.
* Direct activities that help to resolve operational and budget issues associated with grants and protocols as directed by the respective PIs and responsible personnel
* Provides strategic planning for regulatory and protocol initiatives for department.

Grants and Regulatory:

* Manages policies and procedures affecting the submission, review, approval, contract negotiation, activation, regulation, tracking, and reporting of the assigned protocols, as well as review and serve as an advisor on the regulatory aspects of grant applications and annual reports according to institutional and external requirements.
* Maintains working knowledge of current Code of Federal Regulation and Good Clinical Practice guidelines as well as a comprehensive understanding of the research trial process, including but not limited to eligibility and disease processes.
* Coordinate and oversee regulatory documents and protocols for maintenance of clinical grade facility per FDA guidance
* Prepare drafts for cell therapy compassionate use protocols for submission and facilitate submission through appropriate internal/external stakeholders
* Provides guidance, evaluation and education to ensure research integrity and compliance with institutional policies, federal regulations, and other clinical practice guidelines.
* Manages applications and annual reports for new drug applications or devices including correspondence to Federal Drug Administration
* Develop and maintains a processing and tracking system for all trial related paperwork

Communications

* Directs the preparation of all relevant results, observations, reports and other documentation required for the investigators, department, external agencies and collaborators, and/or stakeholders.
* Develops and achieves clinical research activities goals for area of responsibility and offers suggestions/recommendations regarding program operations with the goal of creating efficiencies
* Provides training and coaching to further develop project management skills. Reports on project status and outcomes.
* Utilizes strong interpersonal skills to maintain working relationships with the Sponsor, study sites, and internal associates whilst working together with internal/external stakeholders facilitating CMC revisions and IND submissions, and submission requirements for projects
* Attends appropriate departmental meetings and institutional continuing education programs, weekly/monthly research meetings as well as site initiation meetings as required

The performance for all expected outcomes is measured by observation by supervisor, reports from physicians and co-workers, the accuracy and timeliness of work produced, and the demonstrated ability to effectively work under stress. The position also requires one to anticipate needs, to recognize situations requiring assistance and have the ability to refer or perform any necessary tasks, and to comprehend the goals of the program and take the initiative in making decisions and taking actions to further these goals.

Working Conditions

This position requires:

Working in Office Environment

No

X

Yes

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

No

X

Yes

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

No

X

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

X

10lbs to 50 lbs

X

More than 50 lbs

X

Pushing/Pulling

Up to 10 lbs

X

10lbs to 50 lbs

X

More than 50 lbs

X

Use computer/keyboard

X

Working Conditions

This position requires:

Working in Office Environment

No

X

Yes

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

No

X

Yes

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

No

X

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

X

10lbs to 50 lbs

X

More than 50 lbs

X

Pushing/Pulling

Up to 10 lbs

X

10lbs to 50 lbs

X

More than 50 lbs

X

Use computer/keyboard

X

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

Preferred: Master's degree in Business Administration or healthcare discipline

EXPERIENCE:
Required: 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: Experience with IND's and or SPIND's. Understanding of Science. Experience with Regulatory. Knowledge FDA guidelines.

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

Company

The University of Texas MD Anderson Cancer Center in Houston is one of the world's most respected centers focused on cancer patient care, research, education and prevention. It was named the nation's No. 1 hospital for cancer care in U.S. News & World Report's 2023 rankings. It is one of the nation's original three comprehensive cancer centers designated by the National Cancer Institute.

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