Clinical Project Specialist

HERE IS WHAT YOU WILL DO:

• Document study plans for distribution to the team, sponsor, and ProTrials management. Review and update study plans throughout the life of the project.
• Develop and/or review study documents, including Protocol, Investigator Brochure, ICF, CRFs, Operations Manual, study aids, and site budget
• Oversee and support the feasibility process via collection and review of site capabilities information
• Proactively manage, review, and approve essential study documents to obtain site activation
• Lead study start-up and site close-out activities, including strategic organization and execution of tasks, as well as lead and/or mentor staff assisting with site activations and site closures
• Participate in TMF QC activities and audits: supervise TMF activities, including coordination of inspection readiness, conduct, and oversee TMF quality control reviews according to study plans. Responsible for the quality of TMF deliverables
• Schedule and attend regular team meetings to track progress and status of team activities. May provide meeting agenda, transcribe or review meeting minutes, newsletters, mass site communications, and track action items to meet the specifications of the project team and sponsor
• Provide informal and formal status reports to sponsor, team, and ProTrials management. Prepare and provide mass dissemination of documents/information to include study sites
• Keep project leadership and CRA/CTA team fully apprised of site and study status
• Participate in the selection and management of outside vendors and their deliverables, such as CROs, DM groups, investigational product packaging, central laboratories, etc.
• Assure compliance with local regulations, Code of Federal Regulations/International Conference on Harmonization (ICH), Good Clinical Practices (GCP) guidelines, and ProTrials and sponsor SOPs
• Support activities related to investigator screening and selection
• Ensure CTA resource planning & resource management, study organization, tracking deliverables and out-of-scope, clinical supplies management, and data collection as needed occur within project requirements.
• Mentor CTA team members and monitor/guide progress by providing feedback and development around goals and deliverables for the assigned study
• Update PM on project progress, resource needs, sponsor issues, and team member performance
• Ensure timely and accurate communication of assigned aspects of the project to the team, including sponsor requirements, instructions and changes
• Run and review time code billing and provides feedback regarding trends and outliers to project team
• Provide review and tracking of site invoices and payments
• Contribute to the Regulatory Authority Inspection Team as reviewer, attend mock inspections/audits, and participate in regulatory inspection/audit as required

HERE IS WHAT YOU BRING TO THE TABLE:

• 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 are required
• Proficiency in eTMF

HERE IS WHAT WE OFFER:

Your wellness matters to us – that’s why we provide full medical, dental, and vision insurance options for you and your family.
We know life doesn’t pause for work – we provide flexible PTO so you can take care of what matters, both personally and professionally.
You invest in your future – and so do we. Our 401(k) plan includes a company match to help you reach your financial goals. 
At ProTrials, we are committed to your growth. Whether you’re looking to expand your skills or take the next step in your career, we provide the support and opportunities you need to keep moving forward.
We have the best coworkers, if we do say so ourselves.