Clinical Project Lead: Start-Up & TMF Focus

ProTrials Research, Inc.; Northern (KY); Hybrid; USD 65,000 - 95,000; Full time

Job summary

ProTrials Research, Inc. is a women-owned, WBENC-certified CRO seeking a Contract Clinical Project Specialist to oversee start-up through close-out of clinical trials, partnering with sponsors, sites, and cross-functional teams.

You will manage study plans, documents (Protocol, ICF, CRFs, TMF), TMF quality, and site activation, mentor CTA staff, and ensure regulatory compliance under ICH-GCP and FDA guidelines.

Qualifications

• 2-4 years of progressive experience as clinical research professional.
• Knowledge of FDA regulations and ICH-GCP Guidelines.
• Advanced proficiency in MS Office software (Word, Excel, PowerPoint).
• Proficiency in eTMF.

Responsibilities

• Document study plans for team, sponsor, and ProTrials management; review and update through the project life cycle.
• Develop and review study documents (Protocol, Investigator Brochure, ICF, CRFs, Operations Manual, study aids, site budget).
• Oversee and support feasibility via site capabilities information.
• Proactively manage essential study documents to obtain site activation.
• Lead start-up and site close-out activities; mentor CTA staff assisting with activations and closures.
• Participate in TMF QC activities and audits, ensuring inspection readiness and TMF quality.
• Schedule and attend team meetings; track action items and share status with sponsor and team.
• Provide status reports to sponsor, team, and ProTrials management; mass dissemination of documents.
• Keep leadership and CTA team updated on site and study status.
• Participate in outside vendors selection and management (CROs, labs, etc.).
• Ensure compliance with FDA, ICH-GCP, and SOPs.
• Support investigator screening and selection activities.
• Manage CTA resource planning, study organization, and data collection per project requirements.
• Mentor CTA team members and provide progress feedback.
• Update PM on progress, resources, sponsor issues, and performance.
• Ensure timely communication of sponsor requirements and changes.
• Review time codes and provide trends feedback to the project team.
• Review site invoices and payments.
• Contribute to Regulatory Authority Inspection Team and participate in inspections.

Skills

Team leadership

Coordination

Attention to detail

FDA regulations knowledge

ICH-GCP knowledge

MS Office (Word/Excel/PowerPoint)

eTMF proficiency

Tools

MS Office

eTMF

Job description

ProTrials Research, Inc. is a women-owned, WBENC-certified CRO seeking a Contract Clinical Project Specialist to oversee start-up through close-out of clinical trials, partnering with sponsors, sites, and cross-functional teams.

You will manage study plans, documents (Protocol, ICF, CRFs, TMF), TMF quality, and site activation, mentor CTA staff, and ensure regulatory compliance under ICH-GCP and FDA guidelines.