Remote Clinical Research Associate (Level I/II)

Regulatory Jobs; United States; Remote; USD 85,000 - 120,000; Full time

Job summary

Regulatory Jobs is seeking an FSP Clinical Research Associate (Level I or II) to join our global team. You will perform and coordinate clinical monitoring and site management tasks, conducting remote or on-site visits to assess protocol compliance and manage essential documentation.

You will ensure audits readiness and maintain relationships with investigational sites, working under ICH-GCP guidelines and SOPs.

Qualifications

• Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent.
• 1 year of experience as a clinical research monitor or completion of PPD Drug Development Fellowship.
• Valid driver's license where applicable.
• Equivalency may be considered with appropriate education/training/experience.

Responsibilities

• Monitors investigator sites using risk-based monitoring; conducts SDR/SDV/CRF reviews and documents observations.
• Participates in investigator meetings and communicates with sponsor staff and site personnel.
• initiates clinical trial sites per procedures to ensure protocol compliance and regulatory obligations.
• Ensures essential documents are complete according to ICH-GCP and regulations; conducts on-site file reviews.
• Provides trial status updates to the Clinical Team Manager and maintains study systems as required.
• Maintains administrative tasks including expense reports and timesheets; supports project publications/tools.

Skills

Clinical monitoring

ICH-GCP knowledge

Regulatory compliance

Root cause analysis

Problem solving

Communication skills

Time management

Teamwork

Microsoft Office

Education

Bachelor's degree in life sciences or RN certification

Tools

Microsoft Office

Job description

Regulatory Jobs is seeking an FSP Clinical Research Associate (Level I or II) to join our global team. You will perform and coordinate clinical monitoring and site management tasks, conducting remote or on-site visits to assess protocol compliance and manage essential documentation.

You will ensure audits readiness and maintain relationships with investigational sites, working under ICH-GCP guidelines and SOPs.