Senior Research Data Coordinator

Mission Statement

The mission of The University of Texas M. D. Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees and the public.

Summary

The primary purpose of the Sr. Coordinator of Research Data position is to collaborate with the research team and principal investigators in managing research protocols, assuring protocol compliance, collecting protocol-specific information utilizing a computer database system and communicating with patients and staff regarding protocol information. Assist and/or coordinate regulatory, clinical and reporting aspects of numerous protocols.

Key Functions

1. Responsible for data coordination on all assigned departmental or multi-center clinical trials:

• Collaborates with the research team and principal investigators in managing research protocols, assuring protocol compliance, collecting protocol-specific information utilizing a paper and/or computer database system and communicating with patients and staff regarding protocol information (survival, follow-ups, and obtaining records from outside institutions)
• Develops, maintains, and enters high quality data in database for protocols and related grants
• Responds and resolves data queries in databases
• Responsible for coordination of correlative studies including phlebotomy, shipping, scheduling, and adherence
• Assists with the preparation of scheduled status reports describing interim data, using the applicable database. (i.e. PDMS, CORe, REDcap, Sponsor Database).
• Assumes responsibilities for minimal risk studies including patient screening, consenting, registration, and data collection documentation, including long-term survival follow-ups
• Maintains milestone logs for patients on assigned clinical trials

1. Assists and communicates with sponsor clinical research associates and/or auditors

• Schedules and prepares for monitor visits in coordination with research team
• Provides direction and information to research monitors on initial vetting and departments monitoring expectations/standards
• Resolves database queries and pending action items for assigned protocols during monitor visits

1. Responsible for data management and analysis of clinical research information for assigned clinical trials and projects:

• Collects and enters high quality and accurate data in assigned database
• Assists faculty with data analysis, as needed
• Responsible for case report forms and queries as assigned.
• 4. Coordinates and maintains regulatory correspondence on assigned studies:
• Communicate verbally and in writing, as needed or as requested by study investigator, with internal reviewers or external agencies
• Coordinates and sends outgoing material and correspondence to institutional, state, and/or federal agencies
• Responsible for administering surveys and maintaining survey data in an appropriate database.
• Works with regulatory coordinators or designee on external SAE reporting
• Works with regulatory coordinators to assist with preparation of required documents for audits

1. Provides coverage for other coordinators:

• Assists with responsibilities and activities within the coordinators' office in accordance with individual strengths and expertise
• Informs appropriate staff and arranges coverage for necessary functions when absent

1. Maintains a high level of professional expertise and credibility through educational programs, including on-site training and off-site conferences:

• Attends departmental research meetings and conferences
• Attends approved off-site meetings and conferences
• Obtains supplemental education as needed through use of reference materials, lectures, etc.
• Arrives punctually at all professional functions

1. Assists with training for newly hired data managers and other research staff members, as designated, regarding data entry, report generation and project management.

• Serves as a mentor and resource to new research data coordinator and other new colleagues
• Shows initiative in educating colleagues of new information (i.e. new federal regulations, new techniques that improves workplace efficiency)
• Creates and/or maintains research data coordinator orientation manual on a regular basis

1. Other duties as assigned

Required Degree: High school diploma or equivalent.

Preferred Education: Bachelor's degree .

Required Experience: Four years of related experience. With preferred degree, no experience required.

Preferred: Two years research study experience. 2-5 years of progressively responsible experience in oncology data management

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