Clinical Research Associate (GenMed - 177490

Piper Companies; United States; Hybrid; USD 110.000 - 130.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

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

Aufgaben

• 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.

Kenntnisse

Onsite monitoring

ICH-GCP knowledge

SDV experience

Communication skills

Travel willingness

Ausbildung

Bachelor’s degree in Life Sciences

Jobbeschreibung

Piper Companies is seeking a Gen Med Clinical Research Associate (CRA) to support clinical trial operations for a leading organization within the biotechnology and pharmaceutical industry. The Gen Med Clinical Research Associate (CRA) will be responsible for conducting onsite monitoring visits, ensuring protocol compliance, and supporting the successful execution of clinical studies across investigative sites. The Gen Med Clinical Research Associate (CRA) allows you to work remotely other than 8-10 days on site monitoring.

Responsibilities of the Gen Med Clinical Research Associate (CRA):

• Conduct onsite monitoring visits, including site qualification, initiation, routine monitoring, and closeout visits.
• Ensure clinical studies are conducted in accordance with ICH-GCP guidelines, study protocols, and regulatory requirements.
• Review source documentation and verify data accuracy within electronic data capture (EDC) systems.
• Identify, document, and resolve site issues while providing guidance and support to investigative site staff.
• Maintain monitoring reports and study documentation in compliance with sponsor and regulatory standards.
• Collaborate with cross-functional clinical teams to ensure study timelines and objectives are met.
• Assess site performance and provide recommendations for process improvements and risk mitigation.

Requirements of the Gen Med Clinical Research Associate (CRA):

• 3+ years of Clinical Research Associate experience within the pharmaceutical, biotechnology, or CRO industry.
• Hands-on experience conducting onsite monitoring visits for clinical trials.
• Strong knowledge of ICH-GCP guidelines, FDA regulations, and clinical trial processes.
• Experience reviewing source documents and performing source data verification (SDV).
• Excellent communication, organizational, and relationship management skills.
• Ability to travel as required to investigative sites.
• Bachelor's degree in Life Sciences, Nursing, or a related field preferred.

Compensation for the Gen Med Clinical Research Associate (CRA):

• Salary range: $110,000 - $130,000 base salary
• Full Comprehensive Benefits: Health, Vision, Dental, PTO, Paid Holiday and Sick Leave if Required by Law.

Keywords:

Clinical Research Associate, CRA, General Medicine, Gen Med, Clinical Trials, Onsite Monitoring, Site Monitoring Visits, ICH-GCP, FDA Regulations, Source Data Verification, SDV, Site Management, Biotechnology, Pharmaceutical, CRO, Clinical Operations, Study Start-Up, Site Initiation Visits, Monitoring Reports, Protocol Compliance, Investigative Sites, EDC, Clinical Research

This job opens for applications on 10/30/2026. Applications for this job will be accepted for at least 30 days from the posting date.

#LI-AG1

#ONSITE