ICONMA
Senior Regulatory Coordinator
ICONMA, Newport Beach, California, us, 92659
Our Client, a Healthcare company, is looking for a Senior Regulatory Coordinator for their Newport Beach, CA location.
Responsibilities:
The Sr. Clinical Research Regulatory Coordinator supports clinical research teams (physicians, nurses, etc.) and with minimal direction and considerable use of independent judgment, facilitates the study startup approval process and maintains documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects. The Sr. Regulatory Coordinator ensures all research studies are compliant with regulations and maintains accurate and up-to-date regulatory files. The Sr. Coordinator is the central resource for regulatory staff conducting clinical research. Understands current regulatory requirements and ensures a smooth submission process to minimize delays to study initiation. Remains informed of current federal, state, and local regulations regarding clinical research and communicates any changes to the study team. Tracks each protocol through the IRB/subcommittee approval process, evaluates for recurrent problems, develops and implements systems to decrease delay in the approval process. Works closely with Investigators and Research Staff on new studies to ensure timely, accurate submissions to the IRB and sponsors. Works with sponsors to ensure all proper regulatory documents are approved and that all documents, access to CRF and databases, monitoring/auditing requirements have been completed prior to the start of a study. Produces and maintains regulatory binders prior to studies starting with all required documents and ensures dedicated electronic study folder is current. Obtains and completes all required documents for new submissions, exemption requests, compassionate uses, amendment applications, continuing review, and closure activities. Completes the External Visitors Checklist to meet badge requirements for access to the institution. Reviews informed consents for institutional language and works with legal and sponsors to ensure CTA language is consistent with consent. Works with multiple IRBs and understands submission process and requirements. Provides institutional authorization for new submissions with WIRB. Provides study, enrollment updates, and SAE reports to Clinical Research Oversight Committee. Works with Investigators to renew NCI/CTEP applications. Participates in all investigator meetings, as required. Maintains working knowledge of current protocols and internal SOPs. Assists with the coordination and review of amendments, annual reports, safety reports, and other regulatory submissions required for maintenance of INDs or IDEs. Serves as a team leader within the clinical research regulatory team and trains new regulatory staff, when appropriate.
Requirements:
Five (5) years of regulatory documentation experience in clinical research required. Thirty (30) to fifty (50) clinical trials completed at minimum. Experience with opening trials, filing applications and submissions for Phase 1 trials. Ability to work in fast-paced environments. FDA and IRB start-up experience. Healthcare experience with mid-size private or larger institutions should only be considered due to the large volume. Experience submitting applications and submissions to IRB (Institution Review Board). Working knowledge of NIH, and OHRP regulatory requirements and ICH GCP guidelines preferred. Bachelor's degree. IRB application submissions, SAE filing, 1572 document completion, training log completion, familiar with site essential documents, editing of informed consents, sponsor audit or even FDA audit experience could be a huge plus. Cancer trials account for approximately 70% of trials. Also support GI, Cardiac, Diabetes, and Neurology. Excellent verbal and written communication skills.
Why Should You Apply?
Health Benefits Referral Program Excellent growth and advancement opportunities
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or expression, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.
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Responsibilities:
The Sr. Clinical Research Regulatory Coordinator supports clinical research teams (physicians, nurses, etc.) and with minimal direction and considerable use of independent judgment, facilitates the study startup approval process and maintains documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects. The Sr. Regulatory Coordinator ensures all research studies are compliant with regulations and maintains accurate and up-to-date regulatory files. The Sr. Coordinator is the central resource for regulatory staff conducting clinical research. Understands current regulatory requirements and ensures a smooth submission process to minimize delays to study initiation. Remains informed of current federal, state, and local regulations regarding clinical research and communicates any changes to the study team. Tracks each protocol through the IRB/subcommittee approval process, evaluates for recurrent problems, develops and implements systems to decrease delay in the approval process. Works closely with Investigators and Research Staff on new studies to ensure timely, accurate submissions to the IRB and sponsors. Works with sponsors to ensure all proper regulatory documents are approved and that all documents, access to CRF and databases, monitoring/auditing requirements have been completed prior to the start of a study. Produces and maintains regulatory binders prior to studies starting with all required documents and ensures dedicated electronic study folder is current. Obtains and completes all required documents for new submissions, exemption requests, compassionate uses, amendment applications, continuing review, and closure activities. Completes the External Visitors Checklist to meet badge requirements for access to the institution. Reviews informed consents for institutional language and works with legal and sponsors to ensure CTA language is consistent with consent. Works with multiple IRBs and understands submission process and requirements. Provides institutional authorization for new submissions with WIRB. Provides study, enrollment updates, and SAE reports to Clinical Research Oversight Committee. Works with Investigators to renew NCI/CTEP applications. Participates in all investigator meetings, as required. Maintains working knowledge of current protocols and internal SOPs. Assists with the coordination and review of amendments, annual reports, safety reports, and other regulatory submissions required for maintenance of INDs or IDEs. Serves as a team leader within the clinical research regulatory team and trains new regulatory staff, when appropriate.
Requirements:
Five (5) years of regulatory documentation experience in clinical research required. Thirty (30) to fifty (50) clinical trials completed at minimum. Experience with opening trials, filing applications and submissions for Phase 1 trials. Ability to work in fast-paced environments. FDA and IRB start-up experience. Healthcare experience with mid-size private or larger institutions should only be considered due to the large volume. Experience submitting applications and submissions to IRB (Institution Review Board). Working knowledge of NIH, and OHRP regulatory requirements and ICH GCP guidelines preferred. Bachelor's degree. IRB application submissions, SAE filing, 1572 document completion, training log completion, familiar with site essential documents, editing of informed consents, sponsor audit or even FDA audit experience could be a huge plus. Cancer trials account for approximately 70% of trials. Also support GI, Cardiac, Diabetes, and Neurology. Excellent verbal and written communication skills.
Why Should You Apply?
Health Benefits Referral Program Excellent growth and advancement opportunities
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or expression, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.
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