Senior Coordinator, Clinical Studies

Sr. Coordinator, Clinical Studies within the Lymphoma Regulatory Submission Team

Protocol Administration
Participates in the departmental protocol review and submission process and actively participates in protocol meetings such as investigators and initiation meetings as required. Provides all study related coordination including writing, submission and maintenance of protocols. Develops and maintains a processing and tracking system for all protocol related paperwork. Collects and develops criteria information for protocol submission.

Protocol Monitoring, Audits, Follow up, and management of Protocol/Regulatory Binders

Participates in protocol monitoring, audits and follow up along with coordinators of research data. Leads all regulatory management efforts for clinical trials as assigned by team and as needed based on departmental priorities and disease team priorities. Ensures conduct of assigned studies is in accordance with Good Clinical Practice, federal regulations and institutional policies. Interact with NCI and Pharmaceutical industry to correct/update protocol documents. Communicate verbally and in writing as needed or as requested by the principal investigator of the study, internal reviewers, external agencies, Institutional Review Board and Clinical Research Committee.

Sponsored Contracts, Budget negotiations, and Amendments

Communicates with sponsors of clinical trials regarding needed contract and/or budget amendments. Initiates the coordination, creation and finalizing of relevant documents/budgets and facilitates processes leading to Institution approval for completion. In coordination with PIs and research staff, enhance budget process including thorough coverage analysis and protocol review for all clinical research studies for the department. Maintains tracking system of budget process and updates PI on the status of budget timeline.

Education Required: Bachelor's degree.

Experience Required: 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