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Coordinator, Research Data

2 months ago

Houston, United States MD Anderson Cancer Center Full time
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.

The primary purpose of the Research Data Coordinator is to assist with CTRC Laboratory's protocol start-up and maintenance activities in collaboration with the CTRC Lab Study Coordination Team, research teams and principal investigators in order to provide independent and advanced assessment of both research and patient care services and operational management for clinical trials. Duties include but are not limited to: 1) assist in the development, maintenance and improvement of data extraction, collection, verification, coding and entry processes for laboratory budgets, data collection sheets and fax order sheets; 2) maintain timely and accurate data/document submission, to include amendments; 3) assist in the preparation of information and reports for abstracts, manuscripts and grants.

JOB SPECIFIC COMPETENCIES

Protocol Analysis and Research Coordination: (40%)

Assist in protocol analysis and budget preparation, ensuring compliance with regulations.

Develop and maintain protocol documents, demonstrating thorough understanding of clinical protocols.

Coordinate with research and lab teams to ensure accuracy and consistency of PK collection sheets and lab instructions.

Manage internal logistics to keep study and lab teams informed of progress and delays.

Communicate with sponsor representatives and external agencies for consistency and documentation maintenance.

Maintains all laboratory specific training to ensure compliance (, EH&S Safety in a Laboratory Environment).

Quality Assurance and Protocol Maintenance (30%)

Collaborate with Clinical Studies Coordinator and sponsors to ensure accurate development of lab manuals and sample collection kits as per protocol.

Review kits, materials, and supplies for compliance prior to finalizing protocol documents.

Proficient in utilizing the LIMS system (ARMADA) for documentation and tracking.

Liaise with various departments and external institutions to maintain protocol documentation standards.

Support study team in preparing protocol documents, and communicate updates to relevant stakeholders including coordinators, department representatives, and laboratory leadership.

Coordination of Services (30%)

Solicits information from Central Lab Staff, Research Study Teams, and Sponsor Monitors to clarify protocol requirements.

Shares information with the Clinical Studies Coordinator via training manuals and other documents beneficial to continuing education of the protocol.

Demonstrate excellent oral and written communication skills when contacting internal regulatory entities, other institutions, external agencies/entities (, Consortium, sponsoring agencies, etc.) by phone, email and/or face to face interactions.

Communicate with appropriate individual(s) regarding upcoming deadlines, meetings, etc.

Other Duties as Assigned

Education
Required: High school diploma or equivalent.

Preferred: Bachelor's degree.

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

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.