The Research Quality Coordinator evaluates the quality of research in collaboration with the study PIs and the Coordination and Data Management Center (CDMC). Assists in all aspects of research quality coordination, including regulatory management, registration and eligibility, record-keeping, protocol compliance, data capture and reporting requirements. The Research Quality Coordinator must have excellent detail orientation, strong written and verbal communication skills, and excellent interpersonal skills. Key Functions:
1. Evaluates the quality of research in collaboration with the study PIs and coordinating center team and assists in all aspects of research quality coordination, including regulatory management, registration and eligibility, record-keeping, protocol compliance, data capture and reporting requirements.
2. Develops and presents training material specific to the coordinator role and study management. Develops additional training material based on identified needs then coordinates and presents the training sessions. Training sessions may be conducted via email, teleconference video conference and/or in-person meetings.
3. Functions as a day-to-day resource and liaison for participating site research staff and PIs in multicenter trial management.
4. Assists in creating study related reports, both aggregate and site specific.
5. May assist in development of protocol, manual of operations, data instruments, and study database.
6. Up to 50% travel within or out of state required for study monitoring activities on multicenter studies.
7. Identifies the need for and assists in writing policies, procedures or other documentation to support monitoring/QC activities
8. Participates in developing SOP's, guidance documents or other tools/templates pertinent to monitoring activities.
9. Manages post-monitoring activities and follow-up on any necessary corrective and preventive actions; escalates unacceptable findings to CDMC leadership.
10. Collaborates with CDMC staff and PIs to identify and implement ways to improve monitoring practices, procedures, and workflows.
11. Other duties as required.Core Competencies
- IC - Analytical Thinking:
- Gather relevant information systematically;
- Break down problems into simple components; and
- Make sound decisions.
- IC - Build Relationships:
- Initiate, develop, and manage relationships and networks; and
- Show sincere interest in others and their concerns.
- IC - Innovative Thinking:
- Approach problems with curiosity and open-mindedness; and
- Offer new ideas, solutions and/or options.
Required: Bachelor's degree in Business Administration, Healthcare Administration or related field.EXPERIENCE:
Required: Three years of professional experience to include two years of clinical research or clinical patient care experience. Additional years of related experience and/or education may be substituted on a one to one basis.
Preferred: Experience in coordination and management of research studies, including large observational studies. Direct experience in remote and onsite monitoring, and as a research coordinator in an academic setting, is preferred.
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