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Job Location: Irvine, CA
The Site Start-Up Specialist is responsible for executing study start-up for assigned protocols with the goal of meeting study start-up timelines. Monitor project plans to meet Site Initiation Readiness at the Investigator Meeting. Ensure the accuracy and quality of deliverables from clinical team and vendors. Maintain project metrics and provide status updates to senior management.
Capable of performing all of the activities and responsibilities with direction of the Site Start-Up Unit Manager, Global Monitoring Operations: Director, Associate Director, or designee as follows:
• Execute study start-up for assigned protocols within timelines by identifying clinical team needs, contracting and managing vendor supported tasks and tracking critical timelines.
• Oversee Site Start-Up projects as liaison for IRB, IRB submission, and consent form review. Reporting metrics to senior management
• 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's standards.
• Review and report on deliverables of vendors.
• Collection and review of essential documents (1572, financial disclosures, etc.).
• 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).
• Develop Standard Operating Procedures and Working Documents to document and communicate unit’s processes and procedures.
• 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.
• Train study team members on current process and study execution modalities
• May deliver training to junior staff on site start-up execution and company's policy and procedures.
Bachelor’s in life sciences or related field
At least 2 years experience in clinical research
Prefer candidate with prior experience as Study Start-Up Specialist but not mandatory
Knowledge of FDA regulations required.
Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft Outlook
Experience with Adobe Acrobat Professional and Microsoft Access a plus
Must possess excellent skill/ability in the following:
Written and Oral Communication
Planning and Organizing
Decision Making, Judgment, and Problem Solving
People Relationships, Influencing Others, Motivating Employees, Team Building
Initiative and Accountability
Proven ability to interact with different functional groups
Ability to easily adapt to a changing environment Must be in Southern California
No Relocation Assistance available.
US Citizenship or Green Card Permanent Resident Status no sponsorship available.
How To Apply:
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