RemoteLeads Logo
Sign Up Sign In

Lead Clinical Research Associate - Contract Position

3 days, 23 hours ago
Anywhere
Contract
Lead
Project Manager
Project and Program Management
Apply Now
ProTrials Research,

ProTrials Research,

ProTrials Research, Inc. | Full Service CRO | CRO Services Woman Owned CRO, full service clinical research organization for medical device & diagnostics, and pharmaceutical & biotechnology industries. ProTrials provides clinical operations professional...

Professional Services
51-250
Founded 1996
View All Jobs 3

Description

  • Provide study oversight and serve as the primary liaison among CRAs, CTAs, investigators, sites, clients, and external vendors.
  • Ensure monitoring activities comply with SOPs, regulations, Good Clinical Practice, key performance indicators, and study requirements.
  • Develop and manage clinical monitoring plans, guidelines, timelines, reports, and monitoring intervals.
  • Review clinical data, CTMS information, and site documentation; coordinate resolution of data discrepancies.
  • Create annotated visit report templates and site management and monitoring strategies.
  • Support team training and development while ensuring study-specific training is completed and documented.
  • Guide CRAs, CTAs, and external CROs during monitoring, co-monitoring, training, and audit visits; review visit reports and monitoring letters.
  • Oversee the TMF/eTMF, including filing and quality control.
  • Track serious adverse events, protocol deviations, enrollment, informed consent forms, study contacts, investigational supplies, and investigational product.
  • Perform qualification, initiation, interim, and close-out visits and prepare required reports as needed.

Requirements

  • RN, bachelor’s degree, or advanced degree in biological sciences or a related field, or an equivalent combination of education, training, and experience.
  • Previous CRA experience preferred.
  • Extensive knowledge of FDA regulations and their practical implementation.
  • Familiarity with the medical and pharmaceutical industry, terminology, and practices.
  • Strong communication, organization, prioritization, presentation, discretion, and accuracy skills.
  • Solutions-oriented approach to problem solving.
  • Willingness to travel and perform remote and on-site monitoring as needed.
  • Proficiency with Microsoft Word, Excel, and PowerPoint.

Benefits

  • Collaborative workplace focused on clinical research and global health impact.
  • Equal opportunity employer committed to a workplace free from discrimination and harassment.

Interested in this position?

Apply directly on the company website

Apply Now

Similar Roles

Helprise

Project Leader - Consumer Complaints Platform Deployment

Helprise

Helprise is seeking a Poland-based Project Leader to coordinate the deployment of a Consumer Complaints platform across approximately 20 international markets and prepare local teams for a future centralized operating model.

Poland Contract Lead Project Manager
1 day, 23 hours ago
Parallax Innovations

Project Manager · Audience Specialist

Parallax Innovations Professional Services

Parallax is seeking a content operations contractor to lead a 3–4 person publishing team producing and optimizing campaign-scale civic content for open-primary election reform across major social platforms.

United States Contract Mid Level Project Manager Social Media Manager
$96k-$96k
Instagram API Notion TikTok
1 day, 23 hours ago
Incident IQ

Strategic Events Manager Contractor

Incident IQ 51-250 Diversified Consumer Services

Incident IQ is seeking a contract Strategic Events Manager to lead large-scale company events and tradeshow sponsorships while supporting the Field and Events Marketing team through its 2027 peak season and maternity leave coverage.

United States Contract Senior Marketing Manager Project Manager
2 days, 23 hours ago
AlphaHire

On-Call IT Program/Project Manager

AlphaHire Professional Services

AlphaGov is seeking a project-based On-Call IT Program/Project Manager to manage task-order delivery, resources, schedules, budgets, and client coordination for a major West Coast port authority.

United States Contract Senior Project Manager
Cybersecurity
3 days, 22 hours ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers