Regulatory Affairs Study Start up Specialist II
Reports to – Director or Manager, Regulatory Affairs Study Start Up,
To manage essential regulatory documentation for submission to country/regional/site Institutional Review Boards (IRB) Ethics Committees (EC) Competent Authorities (CA) and/or other Regulatory bodies for all clinical studies performed globally. To interact with, assist and advise study teams, site personnel, sponsors and management to facilitate timely collection, assessment and processing of essential regulatory documentation and to provide ongoing status reports about the documentation. Maintain essential regulatory documentation for multiple studies and perform review, reconciliation, close-out and archiving activities of study or project documentation according to sponsor SOP’s and the business.
- Assist/advise project teams on all regulatory requirements for clinical studies
- Perform compliance assessments according to country requirements and document any activity discovered: notify managers or project findings.
- Review and adapt study specific documents according to each Country and site requirements
- Perform IRB/EC/CA and/or other regulatory bodies’ submissions on behalf of sponsors and/or sites as agreed with the sponsor and in accordance with each country requirements.
- Receive and process study documentation form sites, check content and quality as well as completeness.
- Interact with site personnel, CPCs, CRA’s, & PM’ for document corrections, clarification or resolution of any incomplete and/or incorrect documentation found during document content quality review.
- Compile regulatory documentation according to the business SOPs, sponsor SOPs and applicable country requirements, perform a QC review of all documentation before submitting to the sites, IRB/EC/CA and/or other regulatory bodies according to local requirements.
- Assist with and adapt Informed Consent Form (ICF) according to IRB/IEC requests on a country or site level.
- Assist in preparation, quality check and filing of site adapted ICF according to local requirements.
- Prepare and QC Clinical Trial Application forms (e.g. CTA/XML) where applicable.
- Interact with Sponsors as needed: forward regulatory documentation, including final regulatory submission packages, if requested, to Sponsor in accordance with Sponsor SOP’s and the business.
- Respond to deficiency letters from IRB/EC/CA/ and/or other Regulatory bodies in liaison with sponsor and study PM or assist sites in their response to IRB according to country and site requirements.
- Compiling and assessing completeness or the RegulatoryPackage for drug release (Regulatory Document Study Start Up Checklist)
- Provide project teams with accurate periodic status reports in accordance with business SOP’s and attend internal and external project meetings as required.
- Accurately apply naming conventions, upload and process all correct and compete study documentation in the study startup module or trackers and study specific TMF system whether electronic or paper.
- Perform review, reconciliation, closeout, and archiving activities of study or project documentation, according to business SOP’s or sponsor SOPs
- Assist with preparation for sponsor or agency audits and inspections.
- Assist with QC and QA of various study related regulatory documents and reports
- Oversee translation of regulatory documents, if needed, on behalf of sponsor, as agreed to in scope.
- Attend internal and external study meetings and regulatory status reports for each site and country during study meetings.
- Sites budgets and sites contracts management, depending from Countries/Regions.
- Ongoing willingness to learn.
- Detail oriented
- Ability to collaborate well in a team environment
- Ability to maintain confidentiality
- Proficient in use of computer and software systems
- Excellent verbal and written communication skills
- Fluent in oral and written English
- Ability to provide superior level of customer service
- Ability to develop, prioritise, organise and manage multiple tasks
- Strong decision making and creative problem solving skills
- Strong understanding and application of principles, concepts, practices, and standards of the CRO industry.
- Working knowledge and understanding of applicable country regulations, International Council on Harmonisation (ICH) Good Clinical Practise (GCP) regulations and guidelines.
REQUIRED EDUCATION AND EXPERIENCE
- Associates or Bachelor’s degree in allied health field such as nursing, pharmacy, or health science or equivalent relevant experience.
- A minimum of 3 – 5 years of relevant pharmaceutical site, or CRO regulatory experience.
- Occasional overnight travel may be required.
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