Regulation and Start-Up Specialist 1

Job Profile Summary

Under general supervision, perform tasks at a country/region level associated with site activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include feasibility or maintenance activities.

With 2 years’ experience in a healthcare environment or equivalent combination of education, training and experience. Established individual contributor who works under general supervision. Delivers objectives that significantly impact results for a job area. Tasks are not typically routine, and may require applying discretion within broad operational boundaries and procedures. Problems faced are general and may require some analysis to resolve.

• Under general supervision, perform feasibility, site activation and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary. Review documents for completeness, consistency and accuracy, under guidance of senior staff.
• Prepare site documents, reviewing for completeness and accuracy.
• Inform team members of completion of regulatory contractual. and other documents for individual sites.

• Distribute completed documents to sites and internal project team members.
• Support the updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.
• Review, track and follow up the progress, the approval and execution of required documents such as questionaires, CDAs, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release

• Site identification and feasibility activities, Regulatory, start-up, and maintenance activities
• Preparation, review, negotiation and management of site regulatory documentation and clinical trial agreements with sites and sponsors
• Maintains, reviews, and reports on site activation performance metrics
• Serves as the primary point of contact for investigative sites and/or sponsors
• Ensures tracking completion of all regulatory and contractual documents for sites
• Establishes project timelines.
• Ensures all site activation activities are performed in accordance with all regulations, SOPs, Work Instructions and project requirements either at the global, regional, or country level and all relevant documents are submitted timely to the Trial Master File as per IQVIA/Sponsor requirements.
• Establishes and/or executes goals and objectives for team(s) as well as tracking and delivering on operational/financial performance.
• Participates in the broader Global Site Activation planning process; contributes to long-mid range goals and plans; and coordinates activities with other managers and their respective sub-families.

bachelors Degree – life science or related field