Senior Regulatory Coordinator

Senior Regulatory CoordinatorLocation: Los Angeles, CAContract Details:Position Type: ContractDuration: 13 weeksPay Rate: $30 - $35/HrWork Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.Shift: Day (5x8 Hours) 8:00 17:00Job Summary:This is a Senior Regulatory Coordinator position in the clinical research field.Key Responsibilities:Preparing and submitting regulatory documentation to Institutional Review Boards (IRB) and study sponsorsSubmitting continuations and amendments to regulatory bodiesTracking and maintaining regulatory documents, including lab certifications, CVs, IRB compliance documentation, correspondence letters, medical licenses, FDA Forms, Delegation of Authority Forms, and Serious Adverse Event submissionsEnsuring compliance with FDA Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) requirementsEnsuring compliance with Local Institutional Review Board (IRB) regulatory requirementsReviewing informed consent forms to ensure compliance with applicable laws and institutional policiesWorking with applicable regulations, institutional policies, Standard Operating Procedures (SOPs), and study-specific protocols, plans, and processesRequired Qualifications:Bachelor's degree3 years in the field of clinical researchExperience with applicable regulations, institutional policies, Standard Operating Procedures (SOPs), and study-specific protocols/plans and processesWorking knowledge of Institutional Review Board (IRB) & Contracts and Grants policies and proceduresExperience in writing research correspondence to IRB and study sponsorsExperience with submitting continuations and amendments to regulatory bodiesExperience tracking regulatory documents (including lab certifications, CVs, IRB compliance and correspondence letters, medical licenses, FDA Forms, Delegation of Authority Forms, Serious Adverse Event submissions, etc.)Experience with FDA Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) as well as Local Institutional Review Board (IRB) regulatory requirementsWorking knowledge of informed consent forms to ensure compliance with applicable laws and Institutional policiesPreferred Qualifications:1 year oncology experienceCCRP certificationEpic ExperienceAbout GTT:GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. As a Native American-owned, economically disadvantaged corporation, we highly value diverse and inclusive workplaces. Our clients are Fortune 500 banking, insurance, financial services, and technology companies, along with some of the nation's largest life sciences, biotech, utility, and retail companies across the US and Canada. We look forward to helping you land your next great career opportunity!Job Number: 26-03765