Site Start-Up Specialist Job Summary
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.
Proficiency with the following tasks is desired:
- Site Regulatory Documents Collection (FDA Form 1572, Signature Pages, etc.)
- Review of Informed Consent Form(s) in order to obtain IRB approval (interface with Legal, Medical Safety Physician, and Study Team for approval of language changes)
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:
Delivers Business Results
- Execute study start-up for assigned protocols within Allergan 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 Allergan 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).
Enhances Organizational Performance
- 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.
Demonstrates Personal Leadership
- 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.
Develops Human Capital
Education & Qualifications
- Train study team members on current process and study execution modalities
- May deliver training to junior staff on site start-up execution and Allergan policy and procedures.
- Maintain professional relationships with team members, Allergan staff and study site staff.
- Set and meet personal and professional goals and objectives.
- Qualified candidates will have a bachelor's in life sciences or related field
- At least 3-5 years experience in clinical research
- Prefer candidate with prior experience as Study Start-Up Specialist
- Knowledge, Skills, and Abilities
- 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
- Presentation Delivery
- 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
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.