Providence Health & Services Clinical Research Regulatory Associate in Mission Hills, California
Providence is calling a Clinical Research Associate I - Regulatory (Full Time / Day Shift) to our Providence Facey Medical Foundation in Santa Monica, CA.
We are seeking a Clinical Research Associate I - Regulatory who will be under the direction of the Clinical Research Manager, coordinates 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. 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. Ensures that all regulatory documents are in compliance and maintained in accordance with ICH/GCP and FDA guidelines. Works collaboratively with the CRA II to assure compliance. Works with Clinical CRAs/CRNs in conducting monitoring visits, responding to monitoring/audit reports and additional research protocol duties as needed. Maintains sponsor, investigator and research personnel regulatory communication and serves as primary contact for all IRB and regulatory correspondence with sponsors and cooperative groups. Works independently under general instructions on a wide variety research studies. Completes assignments within strict deadlines with a high degree of accuracy and efficiency. Readily adapts to the environment and the organizational culture. Positively supports the organization and the research team, and fosters harmonious external and internal working relationships.
In this position you will:
Assure that all the open protocols, informed consents, 1572s, and financial disclosures are in compliance with all regulatory standards. This includes, but is not limited to, FDA, DHHS, OHRP, and the IRB
Maintain current study forms, training documents and signature logs for all studies; current CVs and licenses for all physicians; CLIA, and CAP licenses, and a current list of Open, Closed and Pending Studies both internally and externally via website
Assure annual renewal of all appropriate studies, financial disclosure of all physicians for all studies and physician memberships to all applicable sponsors, CTSU, cooperative groups and NCI
Maintain all research Excel spreadsheets, research databases and protocol/pocket cards for all staff and MD's. This includes maintaining all subject accrual, protocol life- cycle tracking and maintaining all in-coming and outgoing financial records for contract/industry-sponsored studies
Maintain regulatory data requested by the sponsor, investigator/research personnel and IRB, FDA and all applicable regulatory agencies. Draft and maintain all Regulatory Department Guidelines accordingly
Initiate all IRB submissions: new protocols, amendments, renewals and closures. Completes all IRB submission forms and letters and serves as liaison between IRB and Sponsors, as appropriate, during IRB approval process. Responsible for all responses to post-IRB review correspondence. Ensure effective communication of new approvals, amendments and closures post IRB-review to all internal and external stakeholders
Assist with drafting all study Informed Consent Forms in compliance with IRB form templates and procedures. Maintain all IRB form templates in conjunction with evolving language set forth by IRB, including maintaining the glossary of terms for IRB consent forms. Drafts and submits all Sponsor IND safety reports and SAEs in accordance with Sponsor and IRB timelines. Maintain SAE and AE internal log for accurate and timely reporting. Work with clinical CRAs/CRNs to obtain accurate information as needed
Do other duties as assigned
Bachelor’s degree or equivalent experience
Two (2)years ofexperienceinclinical researchregulatory
Proficient in Good Clinical Practices
Proficient in Medical Terminology
Knowledge of Institutional Review Board (IRB)
Familiar with ICH/GCP, FDA, and IRB guidelines
Demonstrate knowledge of computer software applications
Organized and detail oriented
Ability to function independently and assertively in a collaborative environment
About the organization you will serve:
Facey Medical Group is a multi-specialty medical group with over 160 physicians providing care to the growing population in the North & East regions of Los Angeles & Ventura Counties. Twelve medical clinics, including two urgent care centers and dedicated women's centers, are located across the San Fernando, Santa Clarita and Simi Valleys. The group began as a single medical practice over 90 years ago.
Facey is part of Providence Health & Services, an integrated, not-for-profit 5-state network of hospitals, care centers, medical clinics, affiliated services and educational facilities spanning from California to Alaska.
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-Mission Hills
Req ID: 248817