Country Study Start Up Specialist II - Clinical Trial Study Start Up and Site Activation

Country Study Start Up Specialist II - Clinical Trial Study Start Up and Site Activation
Location: Lake County / Abbott Park, IL or Remote - onsite preferred but not mandatory
Length of Assignment: 1 year initial contract
Pay Rate: $59-63/hr (medical benefits available at a cost)

The Country Study Start Up Specialist II proactively drives and executes study start-up and maintenance activities for assigned clinical studies and sites. This role develops country and site activation plans, manages essential regulatory and ethics documentation, coordinates cross-functional activation requirements, and maintains inspection-ready records, metrics, and timelines.

• Ensure timely, accurate, and high-quality execution of study start-up and maintenance activities for assigned sites and studies.
• Establish country and site activation plans and priorities, including risk assessments and mitigation plans, in partnership with country operations, study management, contracts, regulatory, and clinical-trial supply teams.
• Proactively identify and communicate issues that may affect delivery and recommend practical solutions.
• Attend regional and area start-up calls and provide updates and input for assigned sites and studies.
• Collect essential documents from investigative sites and complete quality checks in accordance with ALCOA principles.
• Compile and submit ethics and other required local document packages, including customized informed-consent forms, patient-facing materials, and safety-reporting documents.
• Coordinate regulatory-authority submission and approval status with Regulatory Affairs and clinical-trial supply partners to align all site-activation requirements.
• Collaborate with contract managers, site monitors, and study-management leads to support timely activation; review site and IRB/EC comments on informed-consent forms and route documents for functional approval.
• Trigger clinical-supply shipments, complete investigational-product release activities, issue site green-light letters, and activate sites in IXRS.
• Track start-up and maintenance activities, country and site intelligence, essential-document lists, performance metrics, and KPIs in Vault SSU.
• Provide start-up updates and metrics to study leadership and maintain audit and inspection readiness.
• Support process-improvement initiatives and train or mentor new Country Start Up Specialists.

Required Qualifications:

• Three to five years of clinical research experience, preferably including at least one year of study start-up management experience within the designated region.
• Demonstrated success executing site start-up and activation activities while managing multiple priorities in a fast-paced clinical-research environment.
• Working knowledge of ICH and GCP guidelines and an operational understanding of the applicable country regulatory environment.
• Experience working effectively with remote and virtual teams.
• Strong interpersonal skills with the ability to build trust and communicate clearly.
• Flexibility and adaptability in response to changing requirements, timelines, and study priorities.

Education:

• Bachelor's degree in a healthcare or scientific field is highly preferred; an equivalent combination of education and relevant experience is acceptable.

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