Regulatory and Start Up Specialist

 

Position Summary: 

The Regulatory and Start Up Specialist (RSS) is an experienced professional in regulatory and site start-up activities. Responsibilities will be dependent upon the location of the RSS and include but are not limited to initial and subsequent clinical trial submission to Competent Authorities and IRB/ Ethics Committees, Informed Consent Form review and adaptation, Essential Document collection and quality review, supporting sites on IRB/EC submissions and provide support to the Site Contract Management group in budget and contract negotiation. The RSS may act as Subject Matter Expert for questions by other in-country members (CRAs, CSSs or others) supporting site start-up activities and may contribute to development or revision of country specific tools and guidance documents to ensure compliance with local and international clinical trials regulations and guidelines. 

This is a remote position and employee must reside in Canada.

Essential functions of the job include but are not limited to: 

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks. 
• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP. 
• Interaction with CA/EC for study purposes and handling responses to the CA/EC.  
• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team as relevant. 
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.  
• Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria. 
• Partner with the assigned site CRA to ensure alignment in communication and secure site collaboration. 
• Prepare. review and manage collection of essential documents required for site activation/IMP release. 
• Customize country/site specific Patient Information Sheet and Informed Consent Forms. 
• Responsible for/facilitates the translation and co-ordination of translations for documents required for submission. 
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables. 
• Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and  other required reviews to secure on time site activation for the assigned sites in the country.  
• When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department. 
• May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study. 
• Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PfM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations. 
• Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF 
• May support the clinical team performing Pre-Study Site Visits.  
• May support process improvement initiatives, training, and mentoring. 
• Performs other duties as assigned by management. 

Qualifications: 

Minimum Required:

• Fluent in English and French
• Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience. 
• 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies 

Other Required: 

• Strong communication and organizational skills are essential. 
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required. 
• Fluency in English and for non-English speaking countries the local language of country where position based. 

Preferred: 

• Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience for the particular country. 
• Experience using milestone tracking tools/systems. 
• Ability to prioritize workload to meet deadlines. 
• Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science 

Competencies 

• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements. 
• Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information. 
• Strong organizational skills. 
• Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located. 
• Ability to work independently in a fast-paced environment with a sense of urgency to match the pace. 
• Must demonstrate excellent computer skills. 
• Good communication, presentation, interpersonal skills, both written and spoken, with an aptitude to learn how to inform, influence, convince, and persuade. 
• Flexible attitude with respect to work assignments, and new learning. 
• Occasional travel may be required. 

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