Clinical Site Start-Up Specialist

A Clinical Site Start-Up Specialist job is available in Bridgewater, NJ, courtesy of Adecco Medical & Science.
This is a long-term contact opportunity for a highly experienced professional specializing in Clinical research.

Key responsibilities:
• Execute study start-up for assigned protocols within sponsor timelines by identifying clinical team needs, contracting and managing vendor supported tasks and tracking critical timelines.
• Monitor project plans and communicates and troubleshoots the leading and lagging indicators to meet Site Initiation Readiness at the Investigator Meeting.
• Ensure the accuracy and quality of site start-up deliverables by reviewing deliverables in reference to company standards.
• Review and report on deliverables of vendors.
• Maintain the tracking of project metrics in Site Start-Up tracker and provide status updates.
• Work with internal groups to meet deliverables (i.e. Patient Recruitment, Clinical Development, and Clinical Planning).
• Manage information sharing (i.e. Site Start-Up tracker, Site Identification Tracking Tools).
• Develop Standard Operating Procedures and Working Documents to document and communicate unit’s processes and procedures.
• Actively share new ideas for efficient and seamless processes during study team meetings.
• Aggressively seek input from other departments on process improvement and implements process improvement for Site Start-Up initiatives.
• Provide agendas, meeting minutes and manages follow up items for all Site Start-Up meetings that are assigned.
• Follow standard processes for the collection and processing of study site start-up documents and site start-up information.
• Proactively inform manager of down-turns in leading site start-up indicators
• Maintain all aspects of Site Start-Up portal documentation by updating trackers and providing frequent study updates.
• Provide oversight and direction to vendors related to site start up tasks by overseeing timely delivery of regulatory documents, reviewing documents for quality, providing feedback on quality of vendor deliverables and providing direction to vendor on task requirements and prioritization.
• Attend clinical team and operational team meetings and provides updates on the timely execution of inter and intra-departmental milestones.
• Schedule and lead site start-up meetings with clinical team and vendors to review any issues, items for escalation, regulatory document issues, and IRB status.
• May mentor junior staff members to improve quality of outcomes and to maintain team morale.
• Estimated travel may be 10%.

Education and Experience:
• Bachelor’s in life sciences or related field.
• 3-5 year’s experience in clinical research .
• Knowledge of FDA regulations required.
• Prior experience as Study Start-Up Specialist (Preferred).

To be considered for this Clinical Site Start-Up Specialist position or other opportunities available through Adecco Medical and Science, please use the "apply now" button to submit your resume or email directly to tiffannie.mckenzie@adeccona.com.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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Reference number US_EN_2_106405_330861