Clinical Project Specialist

ProTrials Research Inc.

. Document study plans for distribution to the team, sponsor, and ProTrials management; review and update study plans throughout the project .

Posted 9/21/2026contractRemote • United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical research management, including study document development, compliance with FDA regulations and ICH-GCP guidelines, and oversight of team activities. Proficient in managing study start-up and close-out processes while ensuring quality control and effective communication with stakeholders.

Highest-signal resume keywords

Clinical Research ManagementFDA Regulations KnowledgeICH-GCP Guidelines KnowledgeETMF ProficiencyMS Office Advanced Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Study Document DevelopmentProtocol ReviewSite Activation ManagementFeasibility AssessmentTMF Quality ControlData Collection ManagementRegulatory ComplianceBudget ManagementInvestigator SelectionAudit Participation

Soft Skills

Attention to DetailLeadershipMentoringCommunicationTeam Coordination

Tools & Technologies

ETMFMS Office

Industry Keywords

Clinical ResearchStudy PlansSite ManagementSponsor CommunicationVendor Management

About the role

Key responsibilities & impact

Document study plans for distribution to the team, sponsor, and ProTrials management; review and update study plans throughout the project
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 and execute tasks and lead or mentor staff supporting activations and closures
Participate in TMF QC activities and audits; supervise TMF activities and inspection readiness; oversee TMF quality control reviews and deliverable quality
Schedule and attend team meetings; track progress, status, minutes, newsletters, communications, and action items
Provide status reports to sponsors, teams, and ProTrials management; disseminate documents and information to study sites
Keep project leadership and CRA/CTA teams informed of site and study status
Participate in selection and management of outside vendors and their deliverables
Ensure compliance with local regulations, FDA/ICH, GCP guidelines, and company and sponsor SOPs
Support investigator screening and selection
Ensure CTA resource planning, study organization, deliverable and out-of-scope tracking, clinical supplies management, and data collection meet project requirements
Mentor CTA team members and provide feedback and development support
Update the PM on project 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

What you’ll need

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