Clinical Research Coordinator Regulatory/Contracts, Research Institute
Location: Whittier, California
Internal Number: 17103
PIH Health is a nonprofit, regional healthcare network that serves approximately 3 million residents in the Los Angeles County, Orange County and San Gabriel Valley region. The fully integrated network is comprised of PIH Health Hospital - Whittier, PIH Health Hospital - Downey and PIH Health Good Samaritan Hospital, 27 outpatient medical locations, a multispecialty medical (physician) group, home healthcare services and hospice care, as well as heart, cancer, women’s health, urgent care and emergency services. The organization is recognized by Watson Health as one of the nation’s Top Hospitals, and College of Healthcare Information Management Executives (CHIME) as one of the nation’s top hospital systems for best practices, cutting-edge advancements, quality of care and healthcare technology. PIH Health is certified as a Great Place to Work TM. For more information, visit PIHHealth.org or follow us on Facebook, Twitter, or Instagram.
The Clinical Research Coordinator – Regulatory/Contracts who will coordinate all the regulatory documents including, but not limited to the protocol, informed consents, 1572s, financial disclosures, investigator CVs, training certificates and other documents as appropriate to all research activities across the California Region. Independently responsible for, but not limited to, drafting all IRB application submissions for new protocols, consents, amendments, renewals, safety reports from sponsors, and website postings/advertisements for submission to the central IRBs. Ensures that all regulatory documents are in compliance and maintained in accordance with ICH/GCP and FDA guidelines. Works independently to assure compliance with the requests of sponsors, IRB and internal managers and directors as needed. Works with Clinical CRAs/CRNs in conducting monitoring visits, responding to monitoring/audit reports and additional research protocol duties as needed. Maintain sponsor, investigator and research personnel regulatory communication and serve as primary contact for all IRB and regulatory correspondence with sponsors and cooperative groups. Duties include assistance with regulatory start-up, submissions, assist with contracts and budget preparation. Must uphold the standards of confidentiality, attendance, and punctuality.
Comprehensive knowledge of Regulatory, sponsor industry studies, informed consents, contracts, FDA regulations, and protocol design and management
Demonstrates knowledge of computer software applications
Comprehensive knowledge of word processing and spreadsheets
Working knowledge of medical research terminology
Bachelor's Degree in related field or equivalent education/experience
Three (3) years’ experience
CITI Training certificates
Contract, budgeting, and grant processing experience
Proficient in Medical Terminology
Knowledge of Institutional Review Board (IRB) requirements
Familiar with ICH/GCP, FDA, and IRB guidelines
Beyond the benefits that come with working for the area's leading community healthcare provider – one that also recognizes the need to ensure patient safety and comfort – you'll enjoy an extremely competitive compensation and benefits package. We are an equal opportunity employer and seek diversity in our workforce. EOE M/F/D/V
PIH Health is the Communities’ Health and Wellness Partner
Our network of highly trained and compassionate physicians, nurses, clinicians, staff and volunteers work tirelessly and collaboratively every day to maintain and enhance the health and wellbeing of every member of our service areas. And when needed, we are here to coordinate care, manage chronic disease, and treat health conditions for the best possible outcomes.
We’re a nonprofit, regional healthcare network with three hospitals, numerous outpatient medical offices, a multispecialty medical (physician) group, home healthcare services and hospice care, as well as heart, cancer, digestive health, orthopedics, women’s health, urgent care and emergency services. Our leadership is dedicated to putting patients first—a cornerstone of our mission, vision and values—as we deliver top-quality healthcare.
We serve more than 3.7 million residents in the Los Angeles County, Orange County and San Gabriel Valley region.
Why PIH Health?
Our culture is built around our core values, which are the guiding principles for everything we do. For over 60 years, PIH Health has maintained a sense of community and a family-like cultur...e where patients are the top priority, and employees and volunteers are proud to be affiliated with such an outstanding organization.
PIH Health Hospital - Whittier
Our Whittier campus delivers outstanding and compassionate care to patients, every day. Among other awards, PIH Health Hospital - Whittier has been named one of the nation’s 100 Top Hospitals® for the third consecutive year by Truven Health Analytics. PIH Health Hospital in Whittier, CA is located 30 minutes east of Los Angeles, close to the Los Angeles and Orange County border. There are many great communities in which to live that surround the hospital. This means easy access to work, great dining, shopping, entertainment and spectacular beaches. Whatever your passion, you’ll find the right place for it here.
PIH Health Hospital - Downey is a nonprofit hospital with a rich, nearly 100-year history of meeting the healthcare needs of its community. The Downey campus is part of the PIH Health comprehensive health network consisting of two hospitals, 18 medical office locations and a host of specialty services. According to US News & World Report, the hospital scores highly in patient safety and orthopedics. With 955 employees, the hospital is the 5th largest employer in the city of Downey.