Regional Clinical Research Associate — 75% Travel

Planet Pharma; Maryland; On-site; USD 70,000 - 100,000; Full time

Job summary

Planet Pharma is seeking a Clinical Research Associate to monitor sites for multiple clinical trials with a heavy travel schedule (up to 75%). The role requires a college degree or allied health certification and 5+ years in clinical research, including field monitoring experience.

Primary responsibilities include conducting site visits, ensuring compliance with ICH-GCP, FDA regulations, and protocol procedures, and coordinating data transmission and site communications.

Qualifications

• Familiarity with drug development, ICH guidelines, GCP and clinical trial processes.
• Experience using electronic Case Report Form (eCRF) platforms.
• Attention to detail and strong organizational skills.
• Ability to work across teams and document actions clearly.
• Willingness to travel up to 75% (land and air).
• Valid driver’s license and work authorization in the US.

Responsibilities

• Manage and monitor site activities for assigned clinical studies, solo or with other CRAs.
• Conduct site qualification, initiation, interim monitoring and close-out visits.
• Ensure protocol and SOPs, FDA regulations, and ICH-GCP guidelines are followed during monitoring.
• Perform site evaluation visits to assess investigators’ capability to conduct studies.
• Provide training on case report forms, monitoring activities and study close-out procedures.
• Resolve issues to ensure site file audits comply with requirements.
• Coordinate communication with investigational sites for visit planning and action items.
• Document accountability, storage conditions, and inventory control of trial materials.
• Serve as primary site contact for study data transmission and correspondence.
• Conduct study close-out visits including product reconciliation and data queries to database lock.

Skills

ICH/GCP knowledge

Clinical monitoring

CRF platforms

Documentation accuracy

Travel readiness

Team collaboration

Computer skills

Education

College degree or allied health certification

Nursing licensure (optional)

Tools

Electronic CRF platforms

Job description

Planet Pharma is seeking a Clinical Research Associate to monitor sites for multiple clinical trials with a heavy travel schedule (up to 75%). The role requires a college degree or allied health certification and 5+ years in clinical research, including field monitoring experience.

Primary responsibilities include conducting site visits, ensuring compliance with ICH-GCP, FDA regulations, and protocol procedures, and coordinating data transmission and site communications.