Providence Health & Services Clinical Research Associate - Regulatory in Santa Monica, California
Providence is calling a Clinical Research Associate I to Providence John Wayne Cancer Institute Santa Monica, CA.
In this position you will:
Under the direction of the Regional Manager of Regulatory Affairs, coordinate all of 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.
Be responsible for, but not limited to, drafting all IRB application submissions for new protocols, consents, amendments, renewals, safety reports from Sponsor, and website postings/advertisements for submission to the Providence IRB per federal regulations.
Ensure that all regulatory documents are in compliance and maintained in accordance with ICH/GCP and FDA guidelines.
Work collaboratively with the CRA II to assure compliance.
Work 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 serves as primary contact for all IRB and regulatory correspondence with sponsors and cooperative groups.
Uphold the standards of confidentiality, attendance and punctuality.
Perform all duties in a manner which promotes team concept and reflects the Sisters of Providence mission and philosophy.
Required qualifications for this position include:
Bachelor's degree or equivalent
2 years of experience in clinical research regulatory
Proficient in Good Clinical Practices
Proficient in Medical Terminology
Knowledge of Institutional Review Board ( IRB ) requirements
Familiar with ICH / GCP, FDA and IRB guidelines
Knowledge of computer software applications
Organized and detail oriented
Ability to function independently and assertively in a collaborative environment
Preferred qualifications for this position include:
SOCRA / ACRP clinical research certification
About the hospital you will serve:
The John Wayne Cancer Institute at Providence Saint John’s Health Center is a cancer research institute dedicated to the understanding and curing of cancer in order to eliminate patient suffering worldwide. The Institute's mission is accomplished by conducting innovative research focused on biological mechanisms to provide new understandings of the cause, diagnosis, control, and cure of cancer; training the next generation of surgical scientists who study and treat cancer; and researching unique experimental treatment services to rapidly develop and test new forms of diagnosis and therapy in order to improve the quality of life and expected survival of those afflicted with cancer.
We offer a full comprehensive range of benefits - see our website for details
As expressions of God’s healing love, witnessed through the ministry of Jesus, we are steadfast in serving all, especially those who are poor and vulnerable.
Providence Health & Services is a not-for-profit Catholic network of hospitals, care centers, health plans, physicians, clinics, home health care and services guided by a Mission of caring the Sisters of Providence began over 160 years ago. 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
Location: California-Santa Monica
Req ID: 209978