Senior Coordinator, Clinical Studies (Regulatory Coverage Determination)

Title

Sr Coord, Clinical Studies

SUMMARY

Provides administrative and patient care services for the coordination of research studies.

JOB SPECIFIC COMPETENCIES
PATIENT CARE Assist with subject screening to determine eligibility for study participation. Coordinates, evaluates and follows patient's participation in clinical trials. Coordinates patient schedule to ensure protocol compliance.

EDUCATION Ensures the conduct of assigned studies is in accordance with Good Clinical Practice, federal regulations and institutional policies. Conducts protocol in-service to a multidisciplinary team in the Clinical and Translational Research Center, outpatient and inpatient areas

DATA/SAMPLE COLLECTION: Assist in monitoring and evaluating patient and family response to the treatment protocol or research study by providing verbal and written or computerized reports.
Report serious adverse events and follow up as needed. Grade toxicities and adverse reactions through personal interviews, by visually monitoring the medical record and/or by talking with the patient and/or family members and local physicians on the telephone. Reports treatment responses, toxicities and adverse treatment reactions to protocol/research sponsors and the Institutional Review Board (IRB) by providing regular written or computerized reports.

Coordinates the collection of patient samples for pharmacokinetic, pharmacodynamic, and other correlative laboratory studies. Coordinates with members of Clinical and Translational Research Center and the Myeloma Tissue Bank, for the collection of samples.

Checks the accuracy of protocol related data and provide protocol guidance to the Clinical Study and Research Data Coordinators.

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