MD Anderson Cancer Center Senior Coordinator, Clinical Studies in Houston, Texas
Review clinical trial to ensure research good clinical practice standards are achieved by confirming accuracy of coverage determination, CTRC budgets, internal budgets/fees, cell therapy lab budgets for clinical trials, regulatory. Works with the DA, regulatory personnel, clinical research personnel, to coordinate these efforts.
Impacts research protocols reimbursements and payments.
Essential Job Functions
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 by making sure that it entails all coverage determination necessary to fulfil patient care deliverables as outlined in the clinical trial as well as ensuring that the CD is in compliance with NCCN guidelines.
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).
Review patient visits, scans, etc., to ensure it aligns with coverage determination for invoicing/reimbursement.
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 the IND Office, CRF, Industry sponsors, local CROs, to ensure compliance of the clinical trial.
Creation and review of Clinical Content Template (CCT) to ensure alignment with Pharmacy guidelines and clinical trial.
Collaborate with various team members to complete CD such as clinical research finance, regulatory team, CTRC, cell therapy lab and other ancillary teams.
Ability to navigate in Epic to review patient information, link clinical trial to patient consent, review the coverage determination associated with the clinical trial and any other duties deemed appropriate as it relates to Epic and the clinical trial.
Marginal Job Functions
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. 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
Requisition ID: 138724
Employment Status: Full-Time
Employee Status: Regular
FLSA: non-exempt, eligible for overtime, and is subject to the provisions of the Fair Labor Standards Act (FLSA)
Work Week: Days
Fund Type: Soft
Pivotal Position: No
Minimum Salary: US Dollar (USD) 59,600
Midpoint Salary: US Dollar (USD) 74,500
Maximum Salary : US Dollar (USD) 89,400
Science Jobs: No