Clinical Project Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Document, assess, and revise study plans throughout the entirety of the project lifecycle.

• Create and/or evaluate study documents, such as Protocol, Investigator Brochure, ICF, CRFs, Operations Manual, study aids, and site budget.

• Oversee and facilitate feasibility by gathering and reviewing site capabilities information.

• Manage, review, and authorize essential study documents required for site activation.

• Lead study initiation and site close-out activities; organize tasks and guide or mentor staff involved in activations and closures.

• Engage in TMF QC activities and audits; supervise TMF operations and ensure inspection readiness.

• Schedule and participate in team meetings; monitor progress, action items, and team activities.

• Provide status updates and distribute documents/information to sponsors, teams, management, and study sites.

• Keep project leadership and CRA/CTA teams apprised of site and study status.

• Take part in the selection and management of external vendors and their deliverables.

• Ensure adherence to local regulations, CFR/ICH, GCP guidelines, and company and sponsor SOPs.

• Assist with investigator screening and selection.

• Oversee CTA resource planning, study organization, tracking deliverables and out-of-scope items, clinical supplies, and data collection.

• Mentor CTA team members while providing constructive feedback and developmental guidance.

• Update the Project Manager regarding progress, resource requirements, sponsor issues, and team member performance.

• Communicate sponsor requirements, instructions, and changes to the team.

• Manage and review time-code billing, offering feedback on trends and outliers.

• Review and monitor site invoices and payments.

• Contribute to activities related to regulatory authority inspections, mock inspections, and audits.

⛳️ Requirements

• 2-4 years of progressive experience as a clinical research professional.

• Ability to lead and provide coordination and oversight of activities and team members as necessary.

• Exceptional attention to detail.

• Knowledge of FDA regulations and ICH-GCP Guidelines.

• Advanced proficiency in MS Office software, including Word, Excel, and PowerPoint.

• Proficiency in eTMF.

🏝️ Benefits

• Comprehensive medical, dental, and vision insurance options for you and your family.

• Flexible paid time off (PTO).

• 401(k) plan with company matching.

• Support and opportunities for skill enhancement and career growth.

• Collaborative team environment.