Senior Clinical Research Associate - MedTech Trials Lead

Rqm-; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

RQM+ in the United States seeks a Senior Clinical Research Associate to support trial sites with monitoring, documentation, and data integrity across studies, ensuring adherence to GCP, ICH, and regulatory requirements.

You will coordinate site visits, manage TMF/ISF, mentor staff, and collaborate with the study team to keep projects on track while traveling to client sites as needed.

Qualifications

• Bachelor's Degree in scientific discipline or healthcare preferred.
• At least 4 years of on-site monitoring experience.
• Strong source data verification experience in complex EMRs.
• In-depth knowledge of GCP and ICH guidelines.
• Proficient with Word, Excel and PowerPoint.

Responsibilities

• Conduct site monitoring visits in line with GCP/ICH and contracted scope.
• Drive subject recruitment plans to match project needs.
• Administer protocol documents and site training.
• Evaluate site practices for protocol compliance and quality.
• Track regulatory submissions, enrollment, CRFs, and data queries.
• Maintain TMF and ISF documentation and file organization.
• Mentor clinical staff and perform co-monitoring and training.
• Collaborate with study team for project execution.
• Support site budget and financial management as needed.

Skills

GCP/ICH knowledge

On-site monitoring

Source data verification

Regulatory compliance

Mentoring clinical staff

Project coordination

Travel readiness

EMR experience

Communication in English

Education

Bachelor's Degree in scientific discipline or healthcare

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

RQM+ in the United States seeks a Senior Clinical Research Associate to support trial sites with monitoring, documentation, and data integrity across studies, ensuring adherence to GCP, ICH, and regulatory requirements.

You will coordinate site visits, manage TMF/ISF, mentor staff, and collaborate with the study team to keep projects on track while traveling to client sites as needed.