Providence Health & Services Clinical Research Associate II - Regulatory in Santa Monica, California
Providence is calling a full time, day shift Clinical Research Associate II - Regulatory to Providence John Wayne Cancer Institute Santa Monica, CA.
Job Summary: Under the direction of the Regional Manager of Regulatory Affairs, coordinates all of the regulatory documents including, but not limited to the protocol, informed consents, 1572s, financial disclosure37, 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 Providence IRB per federal regulations. 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 grant preparation, IND applications, contracts and budget preparation. Must uphold the standards of confidentiality, attendance and punctuality. Performs all duties in a manner which promotes team concept and reflects the Sisters of Providence mission and philosophy.
In this position you will:
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. Ensures effective communication of new approvals, amendments and closures post IRB-review to all internal and external stakeholders.
Be responsible for drafting all study Informed Consent Forms in compliance with IRB form templates and procedures. Maintains 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 AE/SAEs in accordance with Sponsor and IRB timelines. Files and submits IND safety reports to the IRB if they meet IRB reporting requirements. Works with clinical CRAs/CRNs to obtain accurate information as needed.
Assist in the development and preparation of IIT trials.
Compile regulatory submissions of IND applications, including annual reviews and communication of significant amendments.
Prepare and/or oversees all the regulatory submissions for grant applications.
Conducts quality reviews of regulatory documents to ensure compliance.
Assist in the process of contract and budgeting as requested.
Serve as liaison and assists with study specific site questionnaires, CDAs and CTAs; maintains protocol pipeline log and communicates with Sponsors as appropriate to expedite all pre- IRB submission processes.
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 disclosures 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 MDs. This includes maintaining 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. Drafts and maintains all Regulatory Department Guidelines accordingly.
Be responsible for communicating sponsor broadcasts and any study-specific communications from Sponsors to the clinical CRA/CRN staff for updates on new study-related forms, study amendments, updates and closures.
Perform other duties as assigned .
Required qualifications for this position include:
Bachelor’s Degree in related field or equivalent experience
3-5 years of experience in clinical research regulatory, oncology preferred
SOCRA/ACRP clinical research certification required within six(6) months of hire into the position
Proficient in Good Clinical Practices
Contract, budgeting and grant processing
Proficient in Medical Terminology
Knowledge of Institutional Review Board (IRB) requirements
Familiar with ICH/GCP, FDA, and IRB guidelines
Demonstrates 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:
Bachelor's Degree in Scientific or health services discipline
Advanced level proficiency with Microsoft Office software (Word, Excel, Outlook)
Good data entry skills
Ability to manage multiple research projects within a fast paced environment; able to collect and manage large amount of data and maintain databases; communicate progress, challenges and results effectively
Excellent communication skills and problem solving skills
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: 236917