Coordinator, Regulatory Compliance

1 month ago

Houston, Texas, United States University of Texas MD Anderson Cancer Center Full time
Coordinator, Regulatory Compliance - Thoracic Head & Neck Medical Oncology

MISSION STATEMENT
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 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 rankings. It is one of the nation's original three comprehensive cancer centers designated by the National Cancer Institute

JOB COMPETENCIES
Therapeutic/Intervention Protocol Coordination


Works independently to prepare research-related protocols (clinical) for review by CRC/IRB/IACUC, including but not limited to initiation/submission/re-submission/termination utilizing Oncore, OneIRB, CTPR, CIRBI, WCG WIRB, etc and eResearch within institutional and departmental guidelines.

Keep assigned faculty fully informed on the status of each protocol. Assumes responsibility for the effective operation of research protocols in collaboration with the Principal Investigator and the study sponsor. Coordinates the activities related to the initial clinical trial submission through just prior to site initiation visit.

Understands and adheres to the policies and procedures related to the conduct of clinical trials.

Coordination of regulatory correspondence/documents for all research studies.


Independently prepare the initial components of the official regulatory binder [electronic Investigator Site File (eISF)] for each sponsored clinical trial.


Communicates verbally and in writing, as needed or as requested by the Principal Investigator of the study, with internal reviewers or external agencies (pharmaceutical companies and /or government sponsors).


Assists in the retrieval of documents required for study start up from Industry Sponsors to ensure timely submissions of clinical trials.

Provide weekly updates and escalates Sponsor/CRO issues concerns to Regulatory compliance lead/Director.

Forecast and tracks metrics and regulatory progress of start up for assigned clinical trials ensuring greenlight within 100 day Institutional timeline

Ensures metrics in MS Teams timeline file is update to date and accurate.

Work with Principal Investigator (PI) to obtain information required for SSU activities and keep PI apprised of study progress.

Assists in the development of study related documents for multicenter trials led by Investigators in our department.


Assist in quality control of study documents required in trial activities for external sites in a multicenter trial led by Investigators in our department.


Develop and maintain tracking system and/or a document library for trial documents to support clinical trial activities for external sites in multicenter trials led by Investigators in our department.


Accountable for the completion of the feasibility questionnaire and working with appropriate team members to ensure accurate completion of the form for timely submission to Sponsor/CRO for accurate assessment of site's capabilities.

Perform long term study activities and data entry for participants enrolled in Cooperative group trials.

Study team access management in OnCore, ePRTCL, OneIRB, and eReg as new study team members are onboarded into the department


Timely uploads of clinical trial monitoring reports/follow up letters into the Quality Management System (QMS) as designated by the Quality manager or designee.

Administrative Functions

Attend weekly timeline meetings with clinical research operations, budget/CTA, onboarding, quality team, and other key stakeholders as required. Attend weekly/monthly research meetings as well as site initiation meetings as required.


Intermediate knowledge of Microsoft office, including PowerPoint, Visio software and institutional programs including PeopleSoft software, in addition to web conferencing platforms.

Collects, reviews, share required documents with Industry partners and tracks all essential documents and provides metrics for the collection of documents.

Regulatory Trial Management

Complete forms and comply within Institutional, State, and/or Federal Regulations for study initiation, conduct, and termination.

Responsible for IRB submissions (MD Anderson IRB or as a single site joining multicenter trials when Sponsor utilizes commercial IRB clinical trial)

Work with Institution's consent editors to further develop the Industry Sponsor's informed consent template to meet required Institutional standards. Ensures accurate harmonization between clinical trial requirements described in the informed consent document are aligned with protocol document.


Serves as department's point of contact for regulatory start up activities, resolving Industry sponsors/CRO queries during regulatory study start up activities.


Participate and assist in the regulatory process by handling communications (via letters, e-mails, telecommunication) from the pharmaceutical sponsors/supporters, clinical research organization (CRO) and the National Cancer Institute (NCI).


Prepare, disseminate, and collect sponsor/supporter generated financial disclosure forms (FDFs), delegation of authority logs (DOA), Investigators curriculum vitae (CV), medical license, maintain and retrieve current laboratory CLIA and CAP.

Work with departments collaborating on research projects to obtain current critical documents


Ensures all required documents are uploaded in eReg (ISF) accurately and on time for Sponsor/CRO to perform quality review for site greenlight prior to site initiation visit.

Accountable for completion of delegation of authority log and initiation of study training

Education and training

Attends departmental research meetings and conferences

Obtains supplemental education as needed through use of reference materials, lectures, etc.

Arrives punctually at all professional functions.

Willingness to develop basic knowledge and understanding of regulatory framework and regulatory requirements

Other duties as assigned

Education Required - Bachelor'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.


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.

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