Position Definition:

The incumbent will serve as a Staff Research Associate III/Clinical Research Coordinator for various project and will provide compliance oversight and day-to-day study coordination activities as assigned by the Manager of Compliance and Contracts. The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI), Manager of Compliance and Contracts, and the Administrative Nurse II.

While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.

Essential Functions:

• Implements the overall direction of clinical research projects as directed by Principal Investigator and/or Manager of Compliance and Contracts
• Administratively and clinically manage an average of four to six clinical trials
• Serve as primary contact for sponsors on administrative and regulatory issues
• Coordinate all aspects of the research protocol & manage the daily study operations, managing research budgets, maintain essential research study documentation
• Maintain all regulatory approvals with Sponsor, UCSF, NCIRE, and SFVA including local, central, or external IRB applications including renewals, amendments, and closeout
• Prepare study materials including, but are not limited to, the informed consent and HIPPA document, case report forms (CRFs), enrollment logs, and drug/device accountability logs per SFVA and FDA guidelines
• Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials
• Create and manage systems for tracking, collecting, and monitoring study progress to ensure adherence to protocol timelines and standard operating procedures
• Collaborate with VA ancillary departments (e.g. Lab Services, Radiology, CTSI) to ensure processes are set up to meet requirements of study protocol
• Obtain, process and ship required specimens per protocol
• Ensures adherence to the enrollment goals of the study; maintains study enrollment timelines
• Work with the PI to manage the day-to-day activities of the study including problem solving, communication and protocol management
• Responsible for providing and documenting Informed Consent
• Schedule all assessment study visits, study procedures, and follow up visits
• Make necessary arrangements as required to evaluate the subject per study protocol
• Report any protocol violation/deviation to the Sponsor, IRB & Regulatory Authorities per protocol guidelines
• Participate in subject recruitment efforts and help train supporting staff
• Coordinate the study Close Out Visit with the sponsor.
• Manage tasks related to pharmacy and laboratory closeout activities including reconciliation of study drug and temperature logs.
• Closeout the IRB and SFVA R&D
• Perform other duties as assigned

Job Requirements:

• Requires a B.S. degree in a scientific discipline, and two to six years of minimum experience with direct research administration
• Minimum of 4 years industry experience, with direct clinical trial management
• MA/MS degree in scientific or related fields strongly preferred
• Has a thorough understanding of IRB, protocols policies and practices for conducting clinical investigations
• Proficient with Microsoft applications (Word, Excel, PowerPoint, and Outlook) other 3^rd party EDC/EMR applications. Familiarity with VA CPRS is desired
• Certificate (or equivalent) in clinical trials education course(s) is desired.
• Knowledge of the Principles of Good Clinical Practice (GCP), HIPAA, Bloodborne Pathogens, International Air Transport Association (IATA).
• Knowledge of IRB, FDA, and other regulatory requirements
• Ability to prioritize and organize a high-volume workload and adapt to changing priorities
• Excellent interpersonal, written/oral communication and organizational skills with the ability to present to various audiences
• Ability to manage multiple projects, tasks and priorities to achieve desired goals independently
• Knowledge of VA’s health care system regarding clinical research trials is desired.
• Strong accuracy and attention to detail
• Excellent organizational skills
• Ability to work autonomously

Working Conditions/Environment:

The work environment for this position is an indoor office environment. The incumbent may sustain posture in a seated position and may utilize a computer terminal for prolonged periods of time.

The base salary range for this position is $66,560.00 - $93,059.20 per year. The base salary actually offered to a successful candidate will take into account various relevant and non-discriminatory business factors including, without limitation, the candidate’s geographic location, job-related experience, knowledge, and skills, and education, as well as internal equity considerations. A successful candidate may also be eligible to earn additional compensation including bonuses.

NCIRE is an Equal Opportunity Employer. This position requires access to United States Government research under the Veterans Administration. Per Veterans Administration regulations surrounding access to US research, qualified US Citizens will be selected over other individuals eligible to work in the United States. If you are eligible to work in the United States, you may still be considered for this position but only if no qualified US citizens apply.