Clinical Project Specialist

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $95k - $125k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚫👨‍🎓 No degree required

👻 Ghost score 0%

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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 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 tasks and lead or mentor staff supporting activations and closures • Participate in TMF QC activities and audits; supervise TMF activities and inspection readiness • Schedule and attend team meetings; track progress, action items, and team activities • Provide status reports and disseminate documents/information to sponsors, teams, management, and study sites • Keep project leadership and CRA/CTA teams informed of site and study status • Participate in selecting and managing external vendors and deliverables • Ensure compliance with local regulations, CFR/ICH, GCP guidelines, and company and sponsor SOPs • Support investigator screening and selection • Manage CTA resource planning, study organization, deliverable and out-of-scope tracking, clinical supplies, and data collection • Mentor CTA team members and provide feedback and development guidance • Update the Project Manager on 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 • Proficiency in eTMF

🏖️ Benefits

• Full medical, dental, and vision insurance options for you and your family • Flexible PTO • 401(k) plan with a company match • Support and opportunities for skills expansion and career advancement • Collaborative coworkers