Remote Gen Med Clinical Research Associate (CRA)

Piper Companies; United States; Hybrid; USD 110,000 - 130,000; Full time

Job summary

Piper Companies seeks a Gen Med Clinical Research Associate (CRA) to support clinical trial operations across investigative sites. The role emphasizes onsite monitoring visits, protocol compliance, and adherence to ICH-GCP standards, with remote work favored except 8-10 days on site.

The CRA will review source documents, verify data in EDC, collaborate with cross-functional teams, and help manage study timelines and site performance while traveling as needed.

Qualifications

• 3+ years of CRA experience in pharma/biotech or CRO.
• Experience monitoring site visits and ICH-GCP compliance.
• Ability to travel to investigative sites.

Responsibilities

• Conduct onsite monitoring visits (qualification, initiation, routine monitoring, closeout).
• Ensure studies meet ICH-GCP, protocols, and regulatory requirements.
• Review source documentation and verify data in EDC systems.
• Document and resolve site issues with investigation staff.
• Maintain monitoring reports and study documentation per standards.
• Collaborate with cross-functional teams to meet timelines.
• Assess site performance and provide recommendations for process improvements.

Skills

Onsite monitoring

ICH-GCP knowledge

SDV experience

Communication skills

Travel willingness

Education

Bachelor’s degree in Life Sciences

Job description

Piper Companies seeks a Gen Med Clinical Research Associate (CRA) to support clinical trial operations across investigative sites. The role emphasizes onsite monitoring visits, protocol compliance, and adherence to ICH-GCP standards, with remote work favored except 8-10 days on site.

The CRA will review source documents, verify data in EDC, collaborate with cross-functional teams, and help manage study timelines and site performance while traveling as needed.