Clinical Project Specialist
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Job Description
Clinical Project Specialist coordinating clinical trial start-up, oversight, and close-out for ProTrials, a women-owned contract research organization. Managing TMF quality, vendors, deliverables, and CTA teams.
Responsibilities:
- Document, review, and update study plans throughout the project lifecycle
- Develop and/or review study documents, including Protocol, Investigator Brochure, ICF, CRFs, Operations Manual, study aids, and site budget
- Oversee and support feasibility through collection and review of site capabilities information
- Manage, review, and approve essential study documents for site activation
- Lead study start-up and site close-out activities; organize tasks and lead or mentor staff supporting activations and closures
- Participate in TMF QC activities and audits; supervise TMF activities and inspection readiness
- Schedule and attend team meetings; track progress, action items, and team activities
- Provide status reports and disseminate documents/information to sponsors, teams, management, and study sites
- Keep project leadership and CRA/CTA teams informed of site and study status
- Participate in selecting and managing external vendors and deliverables
- Ensure compliance with local regulations, CFR/ICH, GCP guidelines, and company and sponsor SOPs
- Support investigator screening and selection
- Manage CTA resource planning, study organization, deliverable and out-of-scope tracking, clinical supplies, and data collection
- Mentor CTA team members and provide feedback and development guidance
- Update the Project Manager on progress, resource needs, sponsor issues, and team member performance
- Communicate sponsor requirements, instructions, and changes to the team
- Run and review time-code billing and provide feedback on trends and outliers
- Review and track site invoices and payments
- Contribute to regulatory authority inspection activities, mock inspections, and audits
Requirements:
- 2-4 years of progressive experience as clinical research professional
- Ability to lead and provide coordination and oversight of activities and team members, as needed
- Exceptional attention to details
- Knowledge of FDA regulations and ICH-GCP Guidelines
- Advanced proficiency in MS Office software, including Word, Excel, and PowerPoint
- Proficiency in eTMF
Benefits:
- Full medical, dental, and vision insurance options for you and your family
- Flexible PTO
- 401(k) plan with a company match
- Support and opportunities for skills expansion and career advancement
- Collaborative coworkers
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