RemoteLeads Logo
Sign Up Sign In

Lead Clinical Research Associate - Contract Position

2 weeks, 6 days 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

Atari

Game Producer: Platform Games

Atari 11-50 Consumer Goods

Atari is seeking a remote Game Producer in its India team to lead the end-to-end development and live operations of short-session platform games based on its classic arcade catalog for channels such as Reddit and MSN.

Europe United States India Contract Mid Level Product Manager Project Manager
Agile HTML Scrum Unity
10 hours, 31 minutes ago
INFUSE

Middle+ Project Manager (Remote, Contract)

INFUSE 251-1K Professional Services

INFUSE is seeking a Middle+ Project Manager to lead cross-functional projects delivering AI and technology solutions, from stakeholder requirements through implementation and process improvement.

Kazakhstan Contract Mid Level Project Manager
3 days, 9 hours ago
INFUSE

Middle+ Project Manager (Remote, Contract)

INFUSE 251-1K Professional Services

INFUSE is seeking a Middle+ Project Manager to lead cross-functional projects delivering AI and technology solutions, from requirements definition through implementation and adoption.

Ukraine Contract Mid Level Project Manager
3 days, 9 hours ago
INFUSE

Middle+ Project Manager (Remote, Contract)

INFUSE 251-1K Professional Services

INFUSE is seeking a Middle+ Project Manager to own the delivery of AI and technology projects, coordinating business and technical teams to improve processes and implement solutions across its global demand generation organization.

Bulgaria Contract Mid Level Project Manager
3 days, 9 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