Regulation and Start-Up Specialist 2

About the role

Under moderate oversight and supervision, serve as a Single Point of Contact (SPOC) to 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.

Responsibilities

• 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
• Update and maintain 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 questionnaires, CDAs, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents
• Prepare and manage site documentation; review and negotiate site documents and contracts with sites and sponsors
• Maintain, review, and report on site performance metrics
• Serve as the primary point of contact for investigative sites
• Track completion of appropriate documents for sites; ensure contracts are fully executed
• Establish project timelines
• Ensure 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
• Establish and/or execute goals and objectives for team(s) as well as tracking and delivering on operational/financial performance
• Participate in the broader Global Site Activation planning process; contribute to long-mid range goals and plans; and coordinate activities with other managers and their respective sub-families

Requirements

• Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education
• 5 plus years of experience
• Bachelor's Degree in Life sciences or a related field and 1-3 years' clinical research or other relevant experience; or equivalent combination of education, training and experience
• 3 years' experience in a healthcare environment or equivalent combination of education, training and experience
• Good interpersonal skills

Pay

$38/hr