Summary

This position will serve as a senior clinical research coordinator for a diverse portfolio of research activities for multiple studies. The portfolio may include multicenter clinical trials (both NIH and industry-sponsored), local investigator-initiated clinical trials, large research grant awards, laboratory-based research, and/or programmatic clinical research activities, such as a clinical database and biorepository. Incumbent will oversee timelines and milestones to ensure that targeted deadlines are met facilitating the development and deployment of educational and training materials for all team members, keeping regulatory and budgetary documents compliant, assisting with the preparation of progress reports, implementing quality assurance standards and liaising with other core/components of studies. The individual should be knowledgeable of the principles of scientific investigation and clinical trials, and capable of in-depth understanding of study protocols.

Job description

Position Definition

This position will serve as a senior clinical research coordinator for a diverse portfolio of research activities for multiple studies. The portfolio may include multicenter clinical trials (both NIH and industry-sponsored), local investigator-initiated clinical trials, large research grant awards, laboratory-based research, and/or programmatic clinical research activities, such as a clinical database and biorepository. Incumbent will oversee timelines and milestones to ensure that targeted deadlines are met facilitating the development and deployment of educational and training materials for all team members, keeping regulatory and budgetary documents compliant, assisting with the preparation of progress reports, implementing quality assurance standards and liaising with other core/components of studies. The individual should be knowledgeable of the principles of scientific investigation and clinical trials, and capable of in-depth understanding of study protocols.

Essential Functions

45% Performs clinical trial project coordination at the SFVA Hematology/Oncology Research Program
20% Contributes to the development of protocols, related documents, manuscripts, and Case Report Forms
15% Assist in preparation of new IRB applications and shepherd through to completion; arrange paperwork for renewal of existing protocols; respond to IRB requests for revisions; and coordinate protocol changes with study sponsors.
10% Aids with managing Principal Investigator lab and biospecimen studies and coordinating crosscutting efforts of bench science with clinical trials.
10% Assist with preparation of grant applications, including revisions and progress reports, manuscript and scientific abstract preparation; additional administrative

Job Requirements

Master’s degree or Bachelor’s degree with research experience required
At least 3 years of clinical trials experience
At least 2 years of regulatory work experience in clinical trials, at 1 year of industry trial experience preferred
Prior experience being part of an academic clinical research group preferred
Excellent organizational and communication skills (both written and verbal)
Strong attention to detail
Flexibility to work both independently and collaboratively
Understand critical aspects of clinical trials including tracking, enrollment, retention, regulatory compliance and data management

Working Conditions/Environment

The work environment is a medical center and biomedical research laboratory. It may include some minor annoyances such as noise, temperature variations, etc. The incumbent may sustain posture in standing or seated position and may utilize a computer terminal for prolonged periods of time.

Requirements

Master’s degree or Bachelor’s degree with research experience required
At least 3 years of clinical trials experience
At least 2 years of regulatory work experience in clinical trials
1 year of industry trial experience preferred
Prior experience being part of an academic clinical research group preferred
Excellent organizational and communication skills (both written and verbal)
Strong attention to detail
Flexibility to work both independently and collaboratively
Understand critical aspects of clinical trials including tracking, enrollment, retention, regulatory compliance and data management

Company overview

NCIRE - The Northern California Institute for Research and Education, Inc. is the leading private nonprofit research institute in the United States exclusively dedicated to advancing Veterans' health research. Founded in 1988 and operating as a 501(c)(3) nonprofit organization, NCIRE partners with the San Francisco VA Health Care System (SFVAHCS) and the University of California San Francisco (UCSF) to conduct groundbreaking biomedical research. The institute supports over 200 MD and PhD principal investigators working across diverse research areas including Alzheimer's disease, cancer, cardiovascular disease, mental health, post-traumatic stress disorder (PTSD), traumatic brain injury (TBI), and substance use disorders. With $70 million in research expenditures, NCIRE manages the largest funded research program within the Veterans Health Administration, operating from 250,000-300,000 square feet of research space on the SFVAHCS campus. The organization's mission focuses on improving health outcomes for Veterans and active military personnel through innovative scientific discoveries, clinical trials, and translational research that bridges laboratory findings to clinical applications.