1. 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 representativ... more details
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 position is to support the Clinical and Translational Research Center Laboratory with Clinical Protocol compliance. Consults and collaborates with clinical investigators at UTMDACC and other sites involved in the trial. Assists with clinical protocol specimen storage and designated shipments, laboratory Instrument maintenance, regulatory compliance and quality assurance.
Key Functions
1.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 (e.g. GCP, EH&S Safety in a Laboratory Environment).
2.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.
3.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 (i.e. NCI, Consortium, sponsoring agencies, etc.) by phone, email and/or face to face interactions.
Communicate with appropriate individual(s) regarding upcoming deadlines, meetings, etc.
4.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. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html
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