MD Anderson Cancer Center Coordinator, Clinical Studies - Fulltime - Genitourinary Medical Oncology in Houston, Texas
Title: Coordinator, Clinical Studies - Fulltime - Genitourinary Medical Oncology
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 2017 rankings. It is one of the nation's original three comprehensive cancer centers designated by the National Cancer Institute.
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 GU protocols according to sponsor and departmental SOPs. Collaborate with multiple departments and/or outside institutions to maintain appropriate regulatory documentation.
Participation in routine monitoring and sufficient, appropriate, and timely responses to sponsor queries. Provides support to the study team in preparing for inspections by regulatory agencies.
Assist in 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 meetings.
Public website updates and maintenance, including but not limited to FDA clinical trials website and the NCI Clinical Trials Reporting Program (CTRP) website.
Organization and development of the multicenter regulatory infrastructure for collection, tracking, sharing, and maintenance of relevant regulatory documentation for collaborating institutions and investigators.
Process and tracking of drug safety letter (external SAEs). Assisting sponsors with the GU SUSAR mailbox.
Protocol preparation, review, and submission for new and amended protocol documents for the Institutional Review Board (IRB), the National Cancer Institute (NCI), the Food and Drug Administration (FDA), and other approving entities.
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.
Professional e-mail, phone, and face-to-face interaction with pharmaceutical company representatives, NCI agents, institutional physicians and staff, and others.
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.
Budgeting and Research Accounting:
Protocol budget creation and budget/payment schedule negotiations.
Protocol Cost Analysis revision, finalization, and submission.
Completion of forms (as specified) for protocol, contract, and budget approval and activation.
Patient reimbursement processing.
Familiar with Institutional contract/financial systems.
Participate in the orientation process of new Clinical Research Group employees as well as ongoing training of current staff regarding regulatory matters. Obtain speakers and schedule workshops.
Attend appropriate departmental meetings and institutional continuing education programs. Share information and develop and/or designate educational presentations for the monthly Clinical Research Group (CRG) meetings and Data Coordinator/Research Nurse staff meetings, as approved by supervisor. Prepare updates on laws/regulations for distribution to CRG members.
Maintain working and teaching 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.
Education Required: Bachelor's degree in Public Health, Healthcare Administration or related scientific field.
Experience Required: Three years experience in area of research study or direct patient care obtained from nursing, data gathering or other related experience. Additional years of related experience and/or education may be substituted on a one to one basis.
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