Biospecimen Coordinator

Overview Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation’s top 10 public universities by U.S. News & World Report. The campus has produced five Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot. Led by Chancellor Howard Gillman, UC Irvine has more than 36,000 students and offers 224 degree programs. It’s located in one of the world’s safest and most economically vibrant communities and is Orange County’s second-largest employer, contributing $7 billion annually to the local economy and $8 billion statewide. To learn more about UC Irvine, visit 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. Responsibilities Under the supervision of the Biospecimen Manager of the Clinical Trials Unit, the Biospecimen Coordinator supports the clinical research efforts of the Chao Family Comprehensive Cancer Center (CFCCC). The incumbent will provide comprehensive coordination and data management of the biospecimen components for investigator‑initiated trials or those sponsored by industry or the National Clinical Trials Network (NCTN), according to current Good Clinical Practices (GCP), Good Laboratory Practices (GLP), internal standard operating procedures (SOPs) and University policies and procedures. The incumbent is responsible for supporting and coordinating all aspects of specimen handling (i.e., timely collection, transporting and shipping) for complex research protocols. Individual must follow protocol specific requirements and research procedures. He/she is responsible for accurate record keeping, for prompt data entry of biospecimen information and resolution of queries in laboratory portals, and for managing and ordering supplies as needed. Assists clinical team with reviewing feasibility for clinical trials requiring biospecimen collection, participates in site initiation visits, and trains clinical research coordinators and/or biospecimen coordinators on specimen handling per protocol and lab manual requirements as needed. Serves as the liaison to sponsors, governing agencies and facilitates 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). Qualifications Required: Experience working with biological specimen collection, processing, and shipment per IATA specifications and standards Experience working in a clinical and/or research laboratory 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 concisely, 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 Demonstrated ability to organize and prioritize a complex and dynamic workload Ability to multitask and meet deadlines, despite interruptions 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/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 data from various sources, analyze data, and prepare reports. Ability to work both independently and as part of team Ability to take initiative and demonstrate strong commitment to duties Ability to analyze problems, implement solutions and multitask Ability to work within a deadline‑driven structure 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) Working knowledge of Electronic Data Capture (EDC) and Electronic Medical Record (EMR) Systems i.e., EPIC, Medidata RAVE, Medio HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities. Minimum three years of clinical research and/or laboratory experience or three years as an Assistant CRC working with Phase I‑IV trials Preferred: Experience with cancer‑related research. Extensive experience with various types of human subject clinical trials (Phase I‑IV) i.e., National Group, Industrial, and Investigator‑authored. Experience with clinical trial management systems, preferably OnCore. Special Conditions May require coordinating and processing specimens outside of normal business hours. May require travel to satellite sites. Benefits Additional benefits include medical insurance, sick and vacation time, retirement savings plans, and discounts and perks. Conditions of Employment Background Check and Live Scan Employment Misconduct Legal Right to work in the United States Vaccination Policies Smoking and Tobacco Policy Drug Free Environment *Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer. California Child Abuse and Neglect Reporting Act E‑Verify Pre‑Placement Health Evaluation Closing Statement The University of California is an Equal Opportunity Employer. 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 Anti‑Discrimination Policy. We are committed to attracting and retaining a diverse workforce along with honoring unique experiences, perspectives, and identities. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable, and welcoming. UCI provides reasonable accommodations for applicants with disabilities upon request. For more information, please contact Human Resources at View phone number on click.appcast.io or View email address on click.appcast.io. #J-18808-Ljbffr