Clinical Project Specialist – Contract

Job not on LinkedIn

🔥 14 hours ago

🇺🇸 United States – Remote

⏳ Contract/Temporary

🟢 Junior

🟡 Mid-level

🚫👨‍🎓 No degree required

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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ProTrials Research Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1996

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

ProTrials Research Inc. is a clinical research organization (CRO) headquartered in the United States, offering a wide range of services to the pharmaceutical, biotechnology, and medical device industries. The company provides quality-driven site management, clinical monitoring, project management, data management, and supportive clinical development services. With a focus on therapeutic areas such as oncology, ophthalmology, central nervous system, infectious diseases, women's health, and medical devices & diagnostics, ProTrials is dedicated to delivering high-quality clinical research. Their services include project management, clinical operations, quality assurance, medical and regulatory support, and they also act as a functional service provider, emphasizing virtual trials and remote monitoring capabilities.

📋 Description

• Document, review, and update study plans throughout the project lifecycle • Develop and/or review clinical study documents, including Protocol, Investigator Brochure, ICF, CRFs, Operations Manual, study aids, and site budget • Oversee and support site feasibility activities • Manage, review, and approve essential study documents for site activation • Lead study start-up and site close-out activities • Lead and mentor staff supporting site activations and closures • Supervise TMF activities and participate in TMF quality control, audits, and inspection readiness • Schedule and attend team meetings; track progress, action items, and team activities • Provide status reports to sponsors, teams, and ProTrials management • Keep project leadership and CRA/CTA teams informed of site and study status • Participate in selection and management of external vendors and deliverables • Ensure compliance with FDA regulations, ICH-GCP, local regulations, and SOPs • Support investigator screening and selection • Manage CTA resource planning, study organization, deliverables, clinical supplies, and data collection • Mentor CTA team members and monitor progress toward goals and deliverables • Update the Project Manager on progress, resource needs, sponsor issues, and team performance • Communicate sponsor requirements, instructions, and changes to the team • Review time-code billing and provide feedback on trends and outliers • Review and track site invoices and payments • Contribute to regulatory authority inspection teams, mock inspections, audits, and regulatory inspections

🎯 Requirements

• 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 • Proficiency in eTMF

🏖️ Benefits

• Equal opportunity employment • Workplace free from discrimination and harassment • Collaborative, supportive, and empowering work environment • Opportunity to contribute to global health and clinical research • Mentorship and development opportunities for CTA team members