Recruitment Number: 4337 Reports To: Working Title: Biospecimen Lab Manager Cost Center: IR7445 Bargaining Unit: FLSA: E Job Code: 009548 Job Location: UCI Medical Center - Orange Percent of Time: 100% Work Schedule: 8am-5pm Appointment: Career
The Biospecimen Lab Manager (BLM) reports to, and is directly responsible to, the Assistant Director of the Clinical Trials Unit (CTU), for all biospecimen related clinical research matters fulfilling the mission of the Chao Family Comprehensive Cancer Center (CFCCC), the University Of California Irvine School Of Medicine and the overall UC Irvine Health enterprise. The NCI-designated Chao Family Comprehensive Cancer Center (CFCCC) is a campus-wide multidisciplinary matrix organization whose goal is to promote and enhance cancer-relevant research and patient care at UC Irvine. The CFCCC provides research resources to its ~175 members engaged in research and offers multidisciplinary cancer care to its patients. The BLM supervises the day-to-day operations of the CTU Biospecimen Lab and a team of biospecimen coordinators. The BLM is directly responsible for ensuring the team's adherence to protocols, appropriate management and distribution of workload, ensuring compliance with institutional, industry and federal biospecimen requirements. The BLM is responsible for supervising, administering, and achieving operational goals and objectives for implementation within his/her specific team. The BLM is directly responsible for the management of staff. The supervisory role is composed of staffing, work assignment, implementing the performance management program, leading staff learning and development, leave management and schedules, and all other HR-related functions. The incumbent is responsible for overseeing and providing comprehensive coordination and data management of the biospecimen components of clinical research trials and specimen correlative trials according to current Good Clinical Practices (GCP), Good Laboratory Practices (GLP), internal standard operating procedures (SOPs) and University policies and procedures. The BLM is responsible for supporting and coordinating protocol specific requirements, research procedures, research chart preparation, data collection and record keeping. Attends clinic to assist the Principal Investigator (PI) with recruitment, screening, consenting, administering questionnaires, answer research patient questions, schedules appointments, etc. Serve as the liaison to sponsors, governing agencies and facilitate transmission of verbal and written communication to national cooperative oncology groups, pharmaceutical companies and other research entities as needed. The incumbent is also responsible for maintaining communication with all elements of a multi-level research network, including attending Disease Oriented Teams (DOTs) meetings, interacting with sponsoring agencies including National Cancer Institute, and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors. In addition, this individual must accurately maintain clinical trial information in the clinical trial management system (OnCore) and adhere to institutional policies and external Cancer Center Support Grant guidelines for reporting to the National Cancer Institute (NCI).
5 to 7 years of related work experience with a Bachelor of Arts/Bachelor of Science, or equivalent experience. Current nationally-recognized clinical research coordinator certification (e.g. Society of Clinical Research Associates (SOCRA), Association of Clinical Research Professionals (ACRP), etc.). Experience working with and processing biological specimens and working in a clinical lab environment. Experience with clinical research and data collection. Ability to interact with the public, faculty, and staff. Ability to establish and maintain detailed and accurate files and records. Strong organizational and verbal communication skills. Willingness to work as a supportive, cooperative member of an interdisciplinary team. Demonstrated high-level communication skills to convey information in a clear and concise way, synthesizing information and presenting it to others. Demonstrated problem-solving capabilities to resolve concerns that arise unexpectedly. Demonstrated ability to research, properly evaluate information, and prepare concise, well organized reports, summaries, and correspondence. Ability to independently exercise discretion and sound judgment. Ability to work collegially and cooperatively in a small office and to establish and maintain cooperative working relationships. Demonstrated skill in interacting with persons of various social, cultural, economic and educational backgrounds. Ability to prioritize assignments and achieve high productivity and quality with short time frames, under rigid deadlines, and /or in environments with frequent workload changes and competing demands. Skill in working independently, taking initiative and following through on assignments. Ability to think critically, compile and analyze data from various sources, and prepare detailed and clear reports. Ability to work both independently and as part of team. Ability to analyze problems, resolve concerns, implement solutions and multitask. Demonstrated experience in maintaining flexibility and adaptability while implementing institutional change. High level of integrity and honesty in maintaining confidentiality. Foster and promote a positive attitude and professional appearance. Strong attention to detail. Working knowledge of computer software including Microsoft Office (Outlook, Word, Excel, and PowerPoint).
Experience at a NCI-designated Comprehensive Cancer Center. Extensive experience with various types of human subject clinical trials i.e., National Group, Industrial, and Investigator-authored. Experience with clinical trial management systems, preferably OnCore.
Below are general guidelines on the position's physical, mental, and environmental working conditions. In accordance with applicable state and federal law, UCI provides reasonable accommodations for applicants with disabilities upon request. For more information, please contact Human Resources at (949) 824-0500.
Bend: Occasionally Squat: Occasionally Crawl: Not Applicable Climb: Occasionally Kneel: Occasionally Handle Objects: Occasionally Push/Pull: Occasionally Reach above Shoulder Level: Occasionally Sit: Frequently Stand: Frequently Walk: Frequently Use Fine Finger Movements: Frequently Carry/Lift Loads up to 25 Pounds: Occasionally Carry/Lift loads between 25-50 lbs: Not Applicable Carry/Lift Loads over 50 Pounds: Not Applicable Read/Comprehend: Constantly Write: Constantly Perform Calculations: Constantly Communicate Orally: Constantly Reason and Analyze: Constantly Chemical/Biological Agent: Not Applicable Construction Activities: Not Applicable Contact with Water/Liquids: Not Applicable Drive Motorized Equipment: Occasionally Confined Spaces: Not Applicable Elevated Work Location: Not Applicable Radioactive Materials: Not Applicable Temperature Variations: Not Applicable Gas System: Not Applicable
Other Working Conditions: May require coordinating and processing specimens outside of normal business hours. May require travel to satellite sites and Irvine Campus.
Final candidate subject to background check. As a federal contractor, UC Irvine is required to use E-Verify to confirm the work status of individuals assigned to perform substantial work under certain federal contracts/subcontracts.
The University of California, Irvine is an Equal Opportunity/Affirmative Action Employer advancing inclusive excellence. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected categories covered by the UC nondiscrimination policy .
Since 1965, the University of California, Irvine has combined the strengths of a major research university with the bounty of an incomparable Southern California location. UCI's unyielding commitment to rigorous academics, cutting-edge research, and leadership and character development makes the campus a driving force for innovation and discovery that serves our local, national and global communities.