Clinical Research Monitor II: MedTech Trials Lead

Regulatory Jobs; Washington (District of Columbia); On-site; USD 90,000 - 150,000; Full time

Job summary

IQVIA MedTech (MCRA) is seeking a Clinical Monitoring Specialist to ensure study sites conduct activities per protocol, GCP and ICH guidelines. You will perform site visits, drive recruitment planning, and maintain clear communications with sites to ensure data integrity and project success.

The role requires a bachelor’s degree and at least one year of on-site monitoring experience, with strong organizational and English communication skills across teams and sites.

Qualifications

• Bachelor's degree in a scientific discipline or health care preferred.
• At least 1 year of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (GCP/ICH).
• Good therapeutic and protocol knowledge as provided in company training.
• Proficiency in Microsoft Word, Excel and PowerPoint.
• Written and verbal communication skills including good command of English.
• Organizational and problem-solving skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

Responsibilities

• Perform monitoring visits in line with scope of work and GCP/ICH guidelines.
• Drive and track subject recruitment plan to enhance predictability.
• Administer protocol training to sites and maintain regular communication.
• Evaluate site practices for protocol adherence and regulatory compliance.
• Track regulatory submissions, recruitment, CRF completion and data queries; may support start-up.
• Ensure TMF/ISF documentation is complete and maintained.
• Create and maintain site management documentation and visit reports.
• Collaborate with study team members for project execution support.
• Possibly support development of site-specific recruitment plans and site finances.

Skills

GCP knowledge

ICH knowledge

English communication

Time management

Regulatory submissions

Team collaboration

Education

Bachelor's degree

Tools

Microsoft Word

Excel

PowerPoint

iPhone/iPad

Job description

IQVIA MedTech (MCRA) is seeking a Clinical Monitoring Specialist to ensure study sites conduct activities per protocol, GCP and ICH guidelines. You will perform site visits, drive recruitment planning, and maintain clear communications with sites to ensure data integrity and project success.

The role requires a bachelor’s degree and at least one year of on-site monitoring experience, with strong organizational and English communication skills across teams and sites.