Clinical Project Specialist – Contract

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

📋 Description

• Document, review, and revise study plans throughout the entire project lifecycle.

• Create and/or evaluate clinical study documents, which encompass Protocol, Investigator Brochure, Informed Consent Form (ICF), Case Report Forms (CRFs), Operations Manual, study aids, and site budget.

• Oversee and facilitate site feasibility activities.

• Manage, assess, and approve essential study documents required for site activation.

• Lead the start-up of studies and the close-out activities of sites.

• Guide and mentor staff involved in site activations and closures.

• Supervise Trial Master File (TMF) activities and engage in TMF quality control, audits, and preparation for inspections.

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

• Provide status updates to sponsors, teams, and ProTrials management.

• Keep project leadership and Clinical Research Associate/Clinical Trial Assistant (CRA/CTA) teams updated on site and study progress.

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

• Ensure adherence to FDA regulations, ICH-GCP, local regulations, and Standard Operating Procedures (SOPs).

• Assist in investigator screening and selection processes.

• Manage CTA resource planning, study organization, deliverables, clinical supplies, and data collection efforts.

• Mentor CTA team members and oversee their progress towards goals and deliverables.

• Inform the Project Manager about progress, resource requirements, sponsor-related issues, and team performance.

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

• Review time-code billing and offer insights on trends and anomalies.

• Review and monitor site invoices and payments.

• Contribute to regulatory authority inspection teams, conduct mock inspections, audits, and participate in regulatory inspections.

⛳️ Requirements

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

• Capability to lead and provide coordination and supervision of activities and team members as necessary.

• Outstanding attention to detail.

• Familiarity with FDA regulations and ICH-GCP Guidelines.

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

• Proficient in electronic Trial Master File (eTMF) systems.

🏝️ Benefits

• Equal opportunity employment.

• A workplace devoid of discrimination and harassment.

• A collaborative, supportive, and empowering work atmosphere.

• An opportunity to make contributions to global health and clinical research.

• Mentorship and development opportunities available for CTA team members.