Sr. Clinical Research Coordinator

University of California, Irvine•Orange, CA

About The Position

Under the supervision of the Lab Research Manager (LRM), the Senior Clinical Research Coordinator (SCRC) supports the clinical research efforts of the Department of Orthopaedic Surgery by providing comprehensive coordination and data management for complicated Phase I-IV protocols according to Good Clinical Practices (GCP), internal standard operating procedure (SOPs), and University policies and procedures. The incumbent is responsible for supporting and coordinating all aspects of the clinical research for protocol specific requirements, research procedures, research chart preparation, data collection, and record keeping. The incumbent will prepare study IRB applications and maintain regulatory compliance. Attends clinic to assist the Principal Investigator (PI) and other research personnel with recruitment, screening, consenting, administering questionnaires, answer patient research questions, schedule 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 multi-level research networks, including attending meetings, interacting with sponsoring agencies including National Institute of Health, and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors. The incumbent is responsible, under the direction of the LRM, to provide training and guidance to other clinical research personnel and trainees, 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. The incumbent is responsible, under the direction of the LRM, for leading and managing pre-study site selection visits (PSSVs) including liaising with all appropriate ancillary medical service units (e.g., Investigational Drug Service, Pathology, Radiology, etc.) for the conduct of the trial for the assigned disease area. In addition, this individual must accurately maintain clinical trial information in the clinical trial management system (OnCore) and adhere to institutional policies and external grant guidelines for reporting to the National Institute of Health (NIH).

Requirements

Ability to interact with the public, faculty and staff.
Ability to establish and maintain files and records
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
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 perform ongoing needs analysis and recommend solutions to resolve concern.
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
Working knowledge of computer software including Microsoft Office (Outlook, Word, Excel, and PowerPoint
Knowledge with various types of human subject clinical trials i.e., National Group, industrial, and investigator-authored.
Bachelor's degree in related area and / or equivalent experience / training.
Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals.
2 or more years of related clinical research coordination work experience with Bachelor of Arts/Bachelor of Science, or equivalent experience.
Demonstrated track record of human subjects research (Phase I, II, III drug trials, and device trials) coordination, informed consent procedures and documents, and IRB submission.
Experience working in a medical/clinical setting and familiarity with medical terminology.

Nice To Haves

Current nationally-recognized clinical research coordinator certification (e.g. Society of Clinical Research Associates (SOCRA), Association of Clinical Research Professionals (ACRP), etc.)
Experience with clinical trial management systems, preferably OnCore
5 to 7 Years of related clinical research coordination work experience with Bachelor of Arts/Bachelor of Science, or equivalent experience

Responsibilities

Supports the clinical research efforts of the Department of Orthopaedic Surgery by providing comprehensive coordination and data management for complicated Phase I-IV protocols according to Good Clinical Practices (GCP), internal standard operating procedure (SOPs), and University policies and procedures.
Responsible for supporting and coordinating all aspects of the clinical research for protocol specific requirements, research procedures, research chart preparation, data collection, and record keeping.
Prepare study IRB applications and maintain regulatory compliance.
Attends clinic to assist the Principal Investigator (PI) and other research personnel with recruitment, screening, consenting, administering questionnaires, answer patient research questions, schedule 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 multi-level research networks, including attending meetings, interacting with sponsoring agencies including National Institute of Health, and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors.
Responsible, under the direction of the LRM, to provide training and guidance to other clinical research personnel and trainees, 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.
Responsible, under the direction of the LRM, for leading and managing pre-study site selection visits (PSSVs) including liaising with all appropriate ancillary medical service units (e.g., Investigational Drug Service, Pathology, Radiology, etc.) for the conduct of the trial for the assigned disease area.
Accurately maintain clinical trial information in the clinical trial management system (OnCore) and adhere to institutional policies and external grant guidelines for reporting to the National Institute of Health (NIH).