Coordinator, Clinical Research Program

The University of Texas MD Anderson Cancer Center in Houston is one of the world's most respected centers focused on cancer patient care, research, education and prevention. It was named the nation's No. 1 hospital for cancer care in U.S. News & World Report's 2018 rankings. It is one of the nation's original three comprehensive cancer centers designated by the National Cancer Institute.

The primary purpose of the Coordinator, Clinical Research Programs is to provide administrative and patient care services for the coordination of research studies.

KEY FUNCTIONS

1. Protocol Submission

• Coordinates IRB submission of new and revision of existing protocols and edit abstract consent documents to be protocol specific.
• Communicate verbally and in writing; as need or as requested by study investigator with reviewers (e.g., Surveillance Committee) or external agencies (e.g., pharmaceutical sponsor governmental study sponsors).
• Work with individual Principal Investigators and nurses to assure that revisions or amendments are submitted and ensures that desired outcomes are reached on a timely basis.
• Collects and develops criteria information for protocol submission.
• Coordinates cooperative (i.e., SWOG, NCI, NSABP) group submissions to ensure timely deadlines are met.
• Coordinates the collection and submission of other regulatory documents as needed to ensure all is gathered and other agencies receive all required paperwork.
• Anticipate and meet deadlines for new protocols and amendments which have time sensitive deadlines.
• Assists in the management and execution of departmental monitoring plan as it relates to regulatory compliance for large-scale and multiple site protocol-related research activities which includes but is not limited to site initiation visits, implementation of clinical trials, quality assurance/control of related and regulatory documents

2. Regulatory Compliance

• Generalized, working knowledge of the USC Title 21
• Complete forms and comply with institutional, state, and/or federal regulations for study in conduct, and termination.
• Coordinate and send outgoing material and correspondence to institutional, state, and/or agencies.
• Maybe required to physically hand carry paperwork through the institutional system for completion, which includes, but is not limited to, carrying protocol related documents from one to another for delivery, obtaining signatures, etc.
• Meet regularly with department coordinator to discuss current status of projects and to manage consistent dialog to achieve department's desired outcome.
• Takes responsibility to make sure that departmental research protocols and projects are in compliance with institutional regulations and other governing agencies.
• Reviews each protocol, abstract and consent prior to submission to ensure institutional and department standards have been met and all required information is included.
• Takes primary responsibility for altering department administration of potential conflict of involving other problematic situations.
• Assist with the monitoring of new regulations and assesses their impact on the department and individual projects.
• Assists with preparation of required regulatory documents for audits by any pharmaceutical/agency sponsor, FDA, NCI, and/or cooperative groups.

3. General Research Administration

• Assist in maintaining a system for tracking of all research related paperwork including submissions, approvals, and amendements.
• Ensures proper authorization has been received before new protocols are opened, assists with reviews and protocol terminations as needed.
• Assists with maintenance of central department regulatory file, files as needed for each assigned protocol and with submission of regulatory documents to sponsors.
• Prepare/collect requested regulatory documents for upcoming monitoring visits as noted in departmental monitor's interim visit reports.
• Acts as the departmental liaison with IRB, OPR, and cooperative groups.
• Assists with and/or maintains departmental protocol priority list.
• Use independent judgment to gather facts and determine appropriate solutions based on regulations, Good Clinical Practice guidelines, and current events relating to human subject research.

4. Professional expertise and multidisciplinary involvement

• Attends research meetings and maintains contact with other institutions participating in studies.
• Attendance of classes and/or trainings relevant to performing job.
• Attendance of institutionally and departmentally required training.
• Assists department research management team with educating faculty and staff on new regulations.
• Prepares reports for committees and meetings to communicate the status of all protocols in relation to regulatory compliance.

5. Other Duties as Assigned

Education
Required: Bachelor's degree.

Experience
Required: Three years experience in area of research study or direct patient care obtained from nursing, data gathering or other related experience. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, one year 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