Clinical Project Specialist

Job not on LinkedIn

🔥 2 minutes 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 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

• 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