Regulatory Specialist - 225808
PRIMARY DUTIES AND RESPONSIBILITIES1. Facilitates the protocol approval process and maintains regulatory compliance for allResearch projects submitted to the Central Research Office (CRO). Prepares andmaintains regulatory documents and Institutional Review Board (IRB) submissions for allclient managed protocols. Plans, prepares and manages timelines for assignedregulatory documentation including initial submissions, meeting requests, protocolassistance and annual reports. Initiates, collects and coordinates information to prepareregulatory documentation packages for review and Monitors and tracks status of pendingprotocols for Research Oversight Committee (ROC) and IRB review and approval Prepares and submits initial protocol, informed consent form, FDA Form 1572 and the investigator brochure and any revisions throughout the course of the study Prepares and submits all study related recruitment materials to the sponsor & IRB for review and approval Monitors, tracks and reports all Serious Adverse Events to IRB and Sponsor Ensures safety letters (i.e. MedWatch reports) are reviewed by the Principal Investigator and submitted to the IRB Prepares and submits interim status reports and final summaries to the sponsor and IRB describing study activity Oversees preparation of all closed study files for archiving in long term storage 2. Serves as contact for research projects and maintains records and corresponds with allparties involved3. Develops and continuously monitors status reports detailing ongoing study submissions/approvals and/or renewal deadlines as required to ensure regulatorycompliance4. Completes regulatory correspondence and composes correspondence for administrative signature as appropriate.5. Coordinates and prepares mail outs including maintaining/updating distribution lists. May be required to compile statistical reports.6. Manages and maintains study postings and related updates for clinical trials 7. Maintains annual update of physician and research staff curriculum vitae, professionallicenses, human subjects protection training and financial disclosure forms.8. Supports the IRB Manager with IRB related activities and projects.9. Coordinates and participates in monitoring visits and internal /external audits ofregulatory files.10. Keeps abreast of federal and local regulations as it relates to clinical research and makesrecommendations to modify process and procedures as necessary.ADDITIONAL DUTIES AND RESPONSIBILITIES1. Coordinates and maintains office supplies and performs other related office supportfunctions as necessary.2. Reads, date stamps and routes all incoming mail.PROFESSIONAL DEVELOPMENT AND LEADERSHIP1. Able to continually sharpen skills with respect to their job responsibilities.2. This position will involve frequent interaction with physicians, sponsors, ContractResearch Organizations and IRBs.ADDITIONAL DUTIES AND RESPONSIBILITIES1. Demonstrate effective professional communication and negotiation skills2. Facilitate and model open communication among all NSH staff involved in the conductof clinical research3. Maintain confidentiality in all aspects of communication4. Foster professional presentation of verbal and written communications5. Assist administration and management with the review, development and implementationof institutional policies and procedures to assist compliance with federal, state and locallaws and regulations related to clinical research6. Maintains a helpful/professional attitude toward staff, patients, physicians and otherclients.7. Other duties as assignedPATIENT POPULATIONEmployees must demonstrate and maintain current knowledge and skills necessary to providecare/services appropriate to the age of the patients served in their department. The grid belowidentifies the age group(s) of patients served, the nature of services provided and the skillsnecessary to provide the care appropriate for the ages of the patients served by this position. Recommended Skills Administration Clinical Research Clinical Trials Confidentiality Finance Negotiation Apply to this job. Think you're the perfect candidate? Apply on company site $(document).ready( function() $(#ads-desktop-placeholder).html(
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n Estimated Salary: $20 to $28 per hour based on qualifications.
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n Estimated Salary: $20 to $28 per hour based on qualifications.
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