Regulation and Start-Up Specialist

Essential Functions

• With moderate oversight and supervision, werve 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. 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 questionaires, CDAs, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents. Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education.

5 plus years of experience

Under moderate supervision, executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional, or country level.
Prepares and manages site documentation; reviews and negotiates site documents and contracts with sites and sponsors; maintains, reviews, and reports on site performance metrics; serves as the primary point of contact for investigative sites; tracks completion of appropriate documents for sites; ensures contracts are fully executed; and establishes project timelines. With
moderate oversight and 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 maintenance activities.

• 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.

Bachelor’s Degree Life sciences or a related field and 1 – 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.
With 3 years’ experience in a healthcare environment or equivalent combination of education, training and experience.
Good interpersonal skills

Pay Rate: $38/hr