Job Description

Senior Coordinator, Clinical Studies

Job Responsibilities

Provides Support for Budgeting and Research Accounting:

* Protocol budget creation and budget/payment schedule negotiations, clinical research agreement amendments relating to compensation language.
* Protocol Coverage Analysis review, finalization, and submission.
* Initiation of protocol contracting process via designated database.
* Completion of forms (as specified) for protocol, contract, and budget approval and activation.

Facilitation of the research charge tracking mechanisms, including creation of protocol tracking spreadsheets for each applicable study, dialogue with research data coordinators ,research nurses and the Research Nurse Supervisor related to the completion of research charges in EPIC and in Prometheus, and reconciliation of research charges to data on the protocol spreadsheets and the patient care company centers.

Clinical research account reconciliation

Coordination of multi-site protocol budgets/contracts with participating KCRC sites along with reconciliation of sponsored payments and tracking of inter-site fund transfers.

Development of ongoing relationships with Industry Sponsors

Development of Master Agreements with Industry Sponsors

Regulatory Compliance:

* Assist in creation and maintenance of applicable regulatory files for all KCRC protocols according to sponsor, institutional and departmental SOPs. Cross check documents submitted for the regulatory file to ensure completeness and compliance. Collaborate with departments and/or outside institutions to maintain appropriate regulatory documentation.
* Participation in routine monitoring and sufficient, appropriate, and timely responses to sponsor queries. Provides support to the study team in preparing for inspections by regulatory agencies.
* Assist in development and maintenance of a regulatory document control system for clinical and laboratory studies. Develop processes for organization, record, and coordination of regulatory-related operations. Monitor and evaluate process changes. Conduct simple analyses of processes and identify and resolve problems and quality issues.
* Organization and development of the KCRC multicenter regulatory infrastructure for collection, tracking, sharing, and maintenance of relevant regulatory documentation for collaborating institutions and investigators.
* Attendance at and preparation for study start-up meetings.

Prepare, plan and assist in regulatory audits by the institution, FDA, or other regulatory bodies.

Provides Support for Institutional and Federal Approval Processes:

* Protocol preparation, review, and submission for new and amended protocol documents for the Institutional Review Board (IRB), the National Cancer Institute (NCI), the Food and Drug Administration (FDA), and other approving entities.
* Quality Assurance to ensure consistency between protocol and related documents and that the protocols are written in accordance with institutional and federal guidelines governing clinical research and lab protocols.

Other:

* Professional e-mail, phone, and face-to-face interaction with pharmaceutical company representatives, NCI agents, institutional physicians and staff, and others.
* Provide coverage for key functions and/or at relevant meetings in the absence of the Administrative Director.
* Act as supervisor of regulatory/financial staff as needed in the absence of Administrative Director.
* Coordinates and acts as mentor to regulatory/financial staff cross-training. Assesses the effectiveness of training programs, identified learning needs, and modifies cross-training orientation process as needed.

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

Additional Information

* Requisition ID: 136278
* 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