Site Activation Specialist/ Contract Negotiator

Overview

Under moderate supervision, this role executes feasibility, site identification, regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional or country level.

This position prepares and manages site documentation, reviews and negotiates site documents and contracts with sites and sponsors, and maintains, reviews, and reports on site performance metrics. The role also serves as the primary point of contact for investigative sites, tracks completion of required documents, ensures contracts are fully executed, and establishes project timelines. In addition, with moderate oversight, support country/region-level tasks related to site activation activities in accordance with applicable local and/or international regulations, SOPs, project requirements, and contractual/budgetary guidelines. Maintenance activities may also be included.

Responsibilities

• Perform feasibility, site activation, and some maintenance activities for investigative sites in assigned studies under moderate oversight and supervision, following applicable regulations, SOPs, and work instructions.
• Work closely with the Site Activation Manager (SAM), Project Management team, and other departments as needed.
• Review documents for completeness, consistency, and accuracy under guidance of senior staff.
• Prepare site documents and review them for completeness and accuracy.
• Notify team members when regulatory, contractual, and other documents for individual sites are complete.
• 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 on the progress, approval, and execution of required documents, including:
  • Questionnaires
  • CDAs
  • Regulatory/ethics approvals
  • Informed Consent Form (ICF)
  • Investigator Pack (IP) release documents.

Requirements

• Bachelor’s Degree in Life Sciences or a related field (required)
• 1–3 years of clinical research or other relevant experience; or an equivalent combination of education, training, and experience
• 3 years of experience in a healthcare environment, or an equivalent combination of education, training, and experience

Compensation & Benefits

• The potential base pay range for this role (annualized): $49,200.00 - $123,000.00
• Actual base pay offered may vary based on job-related qualifications (knowledge, skills, education, and experience), location, and/or schedule (full-time or part-time).
• Depending on the position offered, incentive plans, bonuses, and/or other forms of compensation may be available in addition to a range of health and welfare and/or other benefits.

Location

Regional or country-level activities (specific location not provided).