The primary purpose of the Laboratory Manager position is to provide responsible supervision and technical management for the Genitourinary (GU) Clinical Research Laboratory (Eckstein Tissue Acquisition Laboratory) and Tissue Bank.
This position directly impacts the department's translational research efforts by providing investigators access to high quality, well-annotated human biospecimens.
The ideal candidate will have experience working in a fast-paced clinical and translational research environment and the ability to manage multiple priorities successfully, excellent verbal and communication skills for effective collaboration with clinical research core lab team members and collaborators, and proven experience leading a clinical research core lab team, including conflict resolution and mentorship.
Key Functions
SUPERVISION
Hires and oversees training of laboratory personnel. Assigns workload, directs and / or assists laboratory personnel as needed.
Evaluates performance and manages disciplinary actions.
Conducts regular staff meetings.
Provides professional and / or technical training concerning research protocols, laboratory techniques, and / or biospecimen sampling methods.
Coordinates educational activities.
Manages quality and timeliness of all Eckstein Tissue Laboratory operations, to include but not limited to implementation of database systems and process automations.
LABORATORY
Manages overall functions of the GU Clinical Research Lab including but not limited to : patient encounters, specimen collection and processing, equipment, supply and inventory reconciliation, and protocol / project management.
Maintains medical laboratory information system by identifying information needs and problems; recommending improvements;
establishing priorities; testing; writing user manuals; training employees; maintaining security and confidentiality.
Implements new programs, tests, methods, instrumentation, and procedures by investigating alternatives; preparing proposals;
developing and performing parallel testing; monitoring progress.
Provides oversight and reviews all laboratory Standard Operating Procedures (SOPs). Trains and supervises personnel on established methods.
Evaluates / revises SOPs as indicated.
Designs and implements a Laboratory Quality Assurance System. Ensures laboratory operations are effective and meet the needs of the department, investigators, industry sponsors, and other key stakeholders.
Expected to perform collections as needed.
Consults with investigators, collaborators, industry representatives, and commercial vendors to modify or develop sample collection and processing procedures.
Assists Principal Investigator (PI) in the design / review of protocol specific collections and processing procedures.
Resolves problems by consulting with pathologists, other laboratory managers, technical coordinators, laboratory directors, physicians, nurses, and other health care professionals;
attending requisite meetings.
COLLABORATIONS
Serves as the liaison between the departments / organizational groups of GU Medical Oncology, Pathology and Lab Medicine, Urology, Interventional Radiology, Institutional Tumor Bank, Clinical & Translational Research Center (CTRC), Stanford Alexander Lab, Xenograft Core Lab, Bone Marrow Aspiration Clinic, Prostate Tissue Bank, and involvement of other departments / organizational groups according to the project's needs.
Provides oversight of the tissue acquisition & distribution process. Through effective supervision, develops processes and procedures to improve specimen tracking documentation, protocol management, inter- and intra-departmental communication, and project turn-around times.
Ensures biospecimen requests are compliant with all relevant policies, procedures, and regulations.
Determines use and requirements of additional laboratory support, including but not limited to CTRC. Monitors progress and performance of support by attending protocol start-up meetings, conference calls, and communication with the GU study team, PI, and / or industry sponsors as needed.
Develops strategies to improve performance; troubleshoots problems as needed.
Provides support to the GU protocol development process with targeted reviews of clinical and laboratory research protocols to ensure biospecimen activities are compliant with relevant federal and local regulations.
MAINTAINS A LEVEL OF PROFESSIONAL EXPERTISE THROUGH EDUCATIONAL PROGRAMS
Attends appropriate departmental meetings and institutional continuing education programs.
Shares information and, as requested by supervisor, develops educational presentations for the Clinical Research Group (CRG) meetings and / or educational sessions.
Maintains working knowledge of clinical trial procedures, current Code of Federal Regulation (CFR), Good Clinical Practice (GCP), International Council for Harmonisation (ICH), Federal Drug Administration (FDA), and institutional guidelines relative to human specimen collections.
Maintains working knowledge of "Biospecimen Best Practices" as developed by National Cancer Institute (NCI), Office of Human Research Protections (OHRP), and International Society for Biological and Environmental Repositories (ISBER).
Maintains professional and technical knowledge by attending annual domestic and international ISBER conferences (if funds are available), educational workshops;
reviewing professional publications; establishing personal networks; participating in professional societies.
OTHER :
Reviews industry related products and services. Presents recommendations for process improvements or expansion of biorepository activities.
Demonstrates excellent oral and written communication skills when contacting other institutions, and agencies (, sponsoring agencies, etc) by phone, email, in-person or virtual interactions.
Assimilates pertinent information in order to compose written correspondence.
Other duties as required.
EDUCATION :
Required : Bachelor's degree.
EXPERIENCE :
Required : Seven years experience in laboratory operations to include two years in a supervisory capacity. Successful completion of the LEADing Self Accelerate and / or LEADing Self Discover programs may substitute for one year of required supervisory or management experience.
Completion of both programs can be substituted for a maximum of two years of supervisory or management experience.
OTHER :
Required : Must pass pre-employment skills test as required and administered by Human Resources.
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.