Coordinator, Clinical Studies – Genitourinary Medical Oncology

Coordinator, Clinical Studies – Genitourinary Medical Oncology

Summary

The Coordinator, Clinical Studies ensures regulatory compliance for the Department of Genitourinary Medical Oncology clinical trials, assists with the institutional and federal approval procedures for research lab and clinical trials and provides education relevant to regulatory matters to the research staff.

Key Functions

Clinical Research Management:

Negotiate with industry sponsors and CRO’s on new and amended clinical trial budgets.

Develop working relationships with GU’s Regulatory team, Clinical staff and Legal Services regarding essential documentation for supporting the clinical trials budgets.

Coordinate with Clinical Research Finance to ensure that all pertinent information is captured for review and approval of the clinical trial budget.

Provide finalized documentation for Legal Services and Office of Sponsored Programs to proceed with signature for contract execution.

Complete Advance Set Up requests to establish funding accounts for clinical trials.

Clinical trial contract invoicing:

Analyze industry grants and initiate the invoicing process in accordance with agreements. Work closely with Grants and Contracts Accounting, Research Nurses, and other study personnel to provide the appropriate information for invoicing.

Interact with external funding agencies to ensure proper invoicing and payment for clinical trials according to the contractual agreements.

Meet regularly with PIs to discuss payment or budget issues.

Ensure invoicing is accurate

Patient reimbursement processing

Account maintenance reconciliation and reporting:

Monthly patient charge reconciliation

Monthly payment account reconciliations

Professional e-mail, phone, and face-to-face interaction with pharmaceutical company representatives, NCI agents, institutional physicians and staff, and others.

Education:

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.

Experience Required – Three years experience in area of research study or direct patient care obtained from nursing, data gathering or other related experience. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, one year 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. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html