Senior Coordinator, Clinical Studies (Regulatory Coverage Determination)

Title

Sr Coord, Clinical Studies

SUMMARY

Review and confirm accuracy of the coverage determination, CTRC budgets, internal budgets/fees, cell therapy lab budgets for clinical trials, and work with regulatory personnel to coordinate making the budgets by providing clinical knowledge to the budget making process

Impacts research protocols reimbursements and payments.

Utilize research nurse knowledge to accurately coordinate the making and maintaining of a coverage determination (CD) worksheet as the single source of truth for the clinical trial. Ensures accuracy of CD and that the clinical trial includes all coverage determination necessary to fulfil patient care deliverables.

Ability to read and interpret the CMS MCD (Medicare Coverage Database).

Understand Local Coverage Determination (LCD) and National Coverage Determination (NCD) guidelines.

Ability to understand and interpret protocol Schedule of Events (SOE), and Informed Consent Document (ICD).

Reviews initial and revision CDs/CTRC worksheets and responds to multidisciplinary team in a timely manner. Review and answer any other CDs/CTRC items that requires a clinical team review or oversight.

Collaborates with different team members to complete CD such as clinical research finance, regulatory team, CTRC, cell therapy lab and other ancillary teams.

Other duties as assigned.

Bachelor's degree. Five years experience in area of research study or direct patient care obtained from nursing, data gathering or related field. Experiene Preferred: LVN or LPN May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, three 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. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html