Overview
Under moderate supervision, this role executes feasibility, site identification, regulatory, start-up, and maintenance activities in accordance with regulations, standard operating procedures (SOPs), and project requirements at the regional or country level.
Responsibilities include preparing and managing site documentation, reviewing and negotiating site documents and contracts with sites and sponsors, maintaining and reporting site performance metrics, and serving as the primary point of contact for investigative sites. The role tracks completion of required documents, ensures contracts are fully executed, and establishes project timelines. Tasks are performed at the country/region level and may also include maintenance activities.
Responsibilities
- With moderate oversight and supervision, perform feasibility, site activation, and some maintenance activities for assigned studies for investigative sites, following applicable regulations, SOPs, and work instructions.
- Work closely with the Site Activation Manager (SAM), Project Management teams, and other departments as needed.
- Review documents for completeness, consistency, and accuracy under the guidance of senior staff.
- Prepare site documents and review them for completeness and accuracy.
- Inform team members when regulatory, contractual, and other site documents are completed.
- Distribute completed documents to investigative sites and internal project team members.
- Update and maintain internal systems, databases, tracking tools, timelines, and project plans with accurate, complete, project-specific information.
- Review, track, and follow up on progress, approval, and execution of required documents such as:
- 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
- Potential base pay range (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 or part-time).
- Depending on the position, 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.