Sr. Biospecimen Coordinator

University of California, Irvine • Orange, CA

1d

About The Position

Under the supervision of the Biospecimen Lab Manager, the Senior Biospecimen Coordinator supports the clinical research efforts of the Chao Family Comprehensive Cancer Center (CFCCC) by providing comprehensive coordination and data management of 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 incumbent is responsible for supporting and coordinating all aspects of the correlative specimen trials for 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.

The incumbent is responsible to provide mentorship and guidance to other Biospecimen Coordinators, demonstrating best practices, and provides ongoing analysis of internal processes and provides recommendations for new policies and procedures to improve overall operational efficiency and customer service.

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).

Requirements

• Experience working with Experience working with and processing biological specimens
• 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 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
• 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, compiles 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
• Bachelor's degree in related area and / or equivalent experience / training.
• 5 to 7 Years of related work experience with Bachelor of Arts/Bachelor of Science, or equivalent experience
• Experience working in a clinical and/or research laboratory environment
• Experience with clinical research and data collection

Nice To Haves

• Working knowledge of Electronic Data Capture(EDC) and Electronic Medical Record(EMR) Systems i.e. EPIC, Medidata RAVE, Medio
• Experience with cancer-related research.
• Current nationally-recognized clinical research coordinator certification (e.g. Society of Clinical Research Associates (SOCRA), Association of Clinical Research Professionals (ACRP), etc.)
• 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.
• Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals.

Responsibilities

• Supports the clinical research efforts of the Chao Family Comprehensive Cancer Center (CFCCC) by providing comprehensive coordination and data management of specimen correlative trials according to current Good Clinical Practices (GCP), Good Laboratory Practices (GLP), internal standard operating procedures (SOPs) and University policies and procedures.
• Responsible for supporting and coordinating all aspects of the correlative specimen trials for 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.
• 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.
• Responsible to provide mentorship and guidance to other Biospecimen Coordinators, demonstrating best practices, and provides ongoing analysis of internal processes and provides recommendations for new policies and procedures to improve overall operational efficiency and customer service.
• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level