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Research Quality Coordinator - Melanoma Medical Oncology

📁
Managerial/Professional
💼
Melanoma Medical Oncology 600630
📅
142994 Requisition #
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The primary purpose of the Coordinator of Research Quality position is to support the Melanoma Medical Oncology Department quality assurance for Clinical Trials. Consults and collaborates with clinical investigators at UTMDACC and other sites. Assist with writing clinical studies with a strong emphasis on the chemistry manufacturing and control (CMC) sections of Investigator Initiated Studies submissions for regulatory approval. Submit Laboratory section of Annual Report to Research Education and Regulatory Management.

KEY FUNCTIONS:

  • Serves as a liaison between the clinical research departments and federal agencies. Ensures regulatory compliance with federal, state and local laws and policies related to institutional sponsored clinical research.
  • Directs the preparation of reports and other documentation required for the department and/or regulatory agencies.
  • Assemble regulatory submissions for study activation as required per FDA regulation, sponsor standard operating procedures (SOPs), institutional and departmental standards and processes.
  • Timely submission of required regulatory documents, including preparation of IND related documents for Compliance Office and oversight of the FDA approval process. Create, update, and maintain current regulatory files for all Melanoma protocols according to sponsor and departmental SOPs. 
  • Collaborate with multiple departments and/or outside institutions to maintain appropriate regulatory documentation. 
  • Provides support to the study team in preparing for inspections by regulatory agencies.
  • Assist in the development and maintenance of a regulatory document control system. Develop processes for organization, record, and coordination of regulatory-related operations.
  • Monitor and evaluate process changes. 
  • Conduct simple analyses of processes and identify and resolve problems and quality issues.
  • Tracking of changes and updates in regulatory laws/guidelines as they occur.  Interpret and communicate changes to appropriate team members, including management.  Coordinate and implement changes as necessary.
  • Attendance at and preparation for study start-up and investigator meetings as required or requested by PI.
  • Public website updates and maintenance, including but not limited to FDA clinical trials website and the NCI Clinical Trials Reporting Program (CTRP) website.
  • Collects documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.).
  • Quality Assurance to ensure consistency between protocol and related documents and that the protocols are written in accordance with institutional and federal guidelines governing clinical research and lab protocols.
  • Evaluate quality systems, regulatory compliance, and areas of product review and release, change control, documentation review and approval.
  • Prepares new and amended protocol documents for submission to the Institutional Review Board (IRB), the National Cancer Institute (NCI), IND Office and other approving entities.
  • Reviews new concepts and comprehends the protocol. Assist with writing and protocol development.
  • Efficient collaboration with physicians and research team (i.e. nurse manager/supervisor(s), laboratory manger, supervisor clinical studies, etc.) to ensure that deadlines are met and all protocols are properly formatted, contain appropriate related documents and appendices (i.e. informed consent, abstract, etc.), and have no typographical or grammatical errors (investigator-initiated protocols) before submission to approving entities. 
  • Assists PI in preparation of any modifications to the scientific protocol in accordance with Federal regulations and University and sponsoring agency policies and procedures.
  • Assists PI with the day to day activities of the study including problem solving, communication and protocol management.
  • Communicates recommendations regarding patient safety, protocol inconsistencies and protocol.
  • Acts as an expert resource and liaison for internal and external agencies and research investigators.
  • Professional e-mail, phone, and face-to-face interaction with pharmaceutical company representatives, NCI agents, institutional physicians and staff, and others.
  • Provides appropriate training and tools for study team members. Documents date of
  • Obtains appropriate signatures and dates on forms in appropriate places.
  • Other duties as assigned. 

EDUCATION:
Required: Bachelor's degree in Business Administration, Healthcare Administration or related field.

EXPEIENCE:
Required: Three years of professional experience to include two years of clinical research or clinical patient care experience. Additional years of related experience and/or education may be substituted on a one to one basis.

Preferred: Working with Clinical Trials. 

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

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