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Regulatory Affairs Specialist

Company: 3SYNC Research
Location: Fort Lauderdale
Posted on: November 22, 2022

Job Description:

Responsibilities Prepare and maintain complete and accurate regulatory documents in support of clinical research studiesPrepare each study specific protocol, informed consent form, HIPAA authorization and other related documents for review by the IRBSupports initial regulatory submission documents for IRB and sponsors to ensure site meets regulatory readiness metrics with a focus on expedited study start upEnsures regulatory submissions are done in a timely manner as to not delay study start upPrepare and submit amendments, yearly requests for continuing approval of open protocols, audits, deviations, adverse event reports, and any other IRB-required submissionsWork with staff members to complete Financial Disclosure Forms for each studyAssist new hires in completing and submitting all required research documentation and trainings by their deadlinesAssist coordinators and site leadership in tracking the training status for existing staff, assisting with updates as neededAssist coordinators in ensuring that all staff on the delegation of authority logs have the appropriate training on fileMaintain study binder, paper or electronic as appropriate, with all IRB related documents and correspondence for each study to ensure audit readiness at all times.Notify staff and Site Manager/Director of upcoming training expiration datesAssist site leadership and coordinators in the preparation for monitoring visits, sponsor audits, and regulatory audits by conducting quality checks of the regulatory binderAssist with the preparation and submission of closeout documents to the sponsors and IRBs including ensuring completeness, audit-readiness and closure of the regulatory binder and appropriate archival of trial dataSupports maintenance oof DOA logs and any other required logs as neededSubmit or support SAE and AE submissions to the IRB as needed and in a timely fashionSupports audit and inspection readiness by ensuring accurate and timely file completionProvide copies of IRB documents to sponsors, as neededAdhere to safety and compliance regulationsJob Type: Full-timePay: $80,000.00 - $95,000.00 per yearBenefits: Dental insurance Health insurance Paid time off Vision insuranceSchedule: 8 hour shift Monday to Friday Weekend availabilitySupplemental pay types: Bonus payAbility to commute/relocate: Fort Lauderdale, FL 33309: Reliably commute or planning to relocate before starting work (Required)Language: English & Spanish (Required)Work Location: One location

Keywords: 3SYNC Research, Fort Lauderdale , Regulatory Affairs Specialist, Other , Fort Lauderdale, Florida

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