Clinical Project Specialist - Contract Position

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