Senior Coord, Research Data

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

KEY FUNCTIONS 

Consenting Patients, Specimen Collection, Processing and Distribution  

·         Supports the overall effective operation of biospecimen management for designated protocols in the department of Gynecologic Oncology and Reproductive Medicine.

·         Recruitment of eligible participants and obtain patient consents for tissue procurement protocols and maintain tissue accrual log as well as  filing system for patient /tissue tracking information.

·         Provides support for effective workflows and documentation related to sample collection, processing and shipment to collaborating research labs within the institution and externally.

·         Coordinates with the Division of Pathology, diagnostic labs, and various clinics to obtain required laboratory specimens for research purposes.

·         Assists in collection and transportation of blood/tissue specimens from operating room, clinic and/or labs (e.g., diagnostics, CTRC, etc.) as needed by protocol.

·         Collects, labels, processes, stores, and/or ships blood, tissue, and other body fluid specimens according to institutional and protocol specific guidelines. 

·         Determine proper archival tissue, request tissue, complete forms, and ship tissue samples.  Duties include communicating with investigator/collaborator to identify appropriate specimen, submitting requests in iLab, contacting external hospitals (as needed), replying to queries, obtaining specimens and tracking the status of specimens for projects/protocols.

·         Arrange shipment of sample boxes with a suitable air freight carrier and contact collaborators or sponsor personnel to coordinate shipments and verify receipt of samples,

·         Coordinate with study team as needed to ensure that airway bills are available for sample shipments.

Data Management 

·         Enters biospecimen data into applicable database(s) in accordance with prescribed procedures (e.g., sponsor database, REDCap, BIMs system, etc.), and may assist in data analysis.

·         Responsible for receiving, confirming and maintaining records of notification/receipt of shipments to sponsor/CRO/MDA labs. 

·         Interacts with investigators and study teams to address questions and resolve queries related to aspects of research biospecimen collection, storage, QC, batching and distribution processing, including accuracy of time points and quality of final product. Follows through and ensures the resolution of queries in a timely manner and to mutual satisfaction; participates in monitor visits as requested.

·         Serves as an information source of sample status for investigators and study teams.

·         Assists with developing and maintaining systems for controlling the organized flow of research requests, specimen collection and distribution records, and specimen storage records.

·         Reconciles and organizes data and records for timely submission of reports on tissue procured.

Provides monthly and ad-hoc reports on sample inventory as requested

Research-related Activities and Study Management  

·         Assists with laboratory management for designated trials as directed.

·         Interacts with members of interdisciplinary team and intra-departmentally to obtain pertinent information and verify the status of ongoing projects.

·         Assists in new protocol start-up processes as directed.  Participates in the development and review of the lab manual, collection sheets and/or biospecimen database(s) for sample and data management in collaboration with Principal Investigator, research scientists and study teams as requested.

·         Assists in protocol amendment process as directed. Participates in the review and revision of lab manual, collection sheets and/or biospecimen database(s) to ensure relevant changes are implemented.

·         Responsible for kit management for all designated protocols; coordinates with investigators, research teams and sponsors to ensure sample collection kits are developed correctly in compliance with protocol and/or adequate supply is maintained.

·         Assists as directed with the development and management of SOPs to support clinical research biospecimen management.

·         Assists lab team in conducting training and education to support research and adherence to policies, SOPs, and best practices. 

·         Completes study-specific training as required to support research functions.

·         Attends department and study-specific meetings as required.

·         Understands and adheres to all (local, institutional, departmental) policies and procedures related to the conduct of research and/or good laboratory practice, as applicable.

·         Verbal, telephone, email and written communications are timely, and intent is clearly communicated with institutional and other personnel.

Other responsibilities as assigned.