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, 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, approval and execution of required documents such as questionnaires, CDAs, regulatory/ethics approvals, 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
• Bachelor's Degree Life sciences or a related field required and
• Other 1 - 3 years clinical research or other relevant experience; or equivalent combination of education, training and experience required
• With 3 years of experience in a healthcare environment, or equivalent combination of education, training and experience.
The potential base pay range for this role, when annualized, is $49,200.00 - $123,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
