Providence is calling a Clinical Research Associate II - Regulatory ( Full Time / Day Shift ) to Providence Saint Joseph's Medical Center in Burbank, CA
In this position you will:
- Coordinate all of theregulatory documents including, but not limited to the protocol, informed consents,1572s, financial disclosures, investigator CVs, training certificates and otherdocuments as appropriate to all research activities across the CaliforniaRegion under the direction of the Regional Manager of Regulatory Affairs
- Be independently responsible for,but not limited to, drafting all IRB application submissions for new protocols,consents, amendments, renewals, safety reports from sponsors, and websitepostings/advertisements for submission to the Providence IRB per federalregulations.
- Ensure that all regulatorydocuments are in compliance and maintained in accordance with ICH/GCP and FDAguidelines.
- Work independently to assure compliance with the requests ofsponsors, IRB and internal managers and directors as needed.
- Work withClinical CRAs/CRNs in conducting monitoring visits, responding tomonitoring/audit reports and additional research protocol duties as needed.
- Maintain sponsor, investigator and research personnel regulatory communicationand serve as primary contact for all IRB and regulatory correspondence withsponsors and cooperative groups.
- Assist with grant preparation, IND applications, contracts andbudget preparation.
- Uphold the standards of confidentiality, attendance and punctuality.
- Perform all duties in a manner which promotes team concept and reflects the Sisters ofProvidence mission and philosophy.
Required qualifications for this position include:
- Bachelor's Degree in related field or highereducation
- 3-5 years of experience in clinical researchregulatory
- SOCRA / ACRP clinical research certification
- Proficient in MedicalTerminology
- Knowledge ofInstitutional Review Board ( IRB ) requirements
- Familiar with ICH / GCP, FDA,and IRB guidelines
Preferred qualifications for this position include:
About the Region you will serve.
For nearly 70 years, Providence Health & Services, Southern California, has provided quality and compassionate health care, building on a tradition of excellence, innovation, teamwork and outreach to those most in need.
Anchored by five award-winning comprehensive medical centers, Providence provides a full spectrum of care that includes a range of specialties, signature services, outpatient and home care and the well-regarded Providence Medical Institute, a group of physicians and primary and urgent care clinics throughout the greater San Fernando Valley and South Bay. Providence is focused on providing the communities it serves with preventive care, education and leading-edge diagnostics and treatment. The organization includes numerous outreach programs. hospice and home care and even our own Providence High School, a Blue Ribbon college-preparatory campus.
We offer a full comprehensive range of benefits - see our website for details
As people of Providence, we reveal God's love for all, especially the poor and vulnerable, through our compassionate service.
Providence Health & Services is the third largest not-for-profit health system in the United States. Providence employs more than 82,000 caregivers (employees) across a five-state area; AK, WA, MT, OR, and CA. Our facilities include 34 hospitals, 600 physician clinics, senior services, supportive housing and other health and educational services. Providence is proud to be an Equal Opportunity Employer. Providence does not discriminate on the basis of race, color, gender, disability, veteran, military status, religion, age, creed, national origin, sexual identity or expression, sexual orientation, marital status, genetic information, or any other basis prohibited by local, state, or federal law.
Job Category: Research
Req ID: 153773