Site Activation Specialist (Contract)

Job Overview
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.

Essential Functions
• With moderate oversight and supervision, werve a Single Point of Contact (SPOC) to perform 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.

Qualifications
• 1-year contract position

• Bachelor's Degree Life sciences or a related field
• Experience in Regulatory Start-Up, CRA, or Study Coordinator (SC) roles are eligible to apply
• Experience with IRB submissions (initial and maintenance)

• Exposure to site budget/contract negotiation activities is preferred

• Good English communication skills required

• Candidates with strong clinical research experience and willingness to develop in site start-up/maintenance activities are encouraged to apply.