Clinical Research Associate (CRA)

Piper Companies is seeking a Clinical Research Associate (CRA) to support a Phase I oncology program for a leading pharmaceutical client. The Clinical Research Associate will be responsible for site monitoring, study execution, protocol compliance, and clinical trial oversight across oncology studies involving solid and/or liquid tumors. This individual must be based in Pacific Time and will travel 8-10 days per month!

Responsibilities of the Clinical Research Associate include:

• Conduct Site Selection, Site Initiation, Routine Monitoring, and Close-Out Visits in accordance with study protocols, GCP, and ICH guidelines
• Monitor clinical trial sites to ensure protocol compliance, data integrity, patient safety, and adherence to regulatory requirements
• Support Phase I oncology clinical trials involving solid and/or liquid tumor indications
• Develop and maintain strong relationships with clinical research sites and study investigators
• Collaborate with sites to develop, implement, and track patient recruitment and enrollment strategies
• Provide protocol training and ongoing study communication to investigators and clinical site staff
• Identify, document, and escalate site performance, compliance, quality, and patient safety issues
• Review source documentation and clinical data to ensure accuracy, completeness, and consistency
• Monitor regulatory submissions, patient recruitment, enrollment, data management, and overall study progress
• Maintain essential study documentation within the Trial Master File (TMF) and Investigator Site File (ISF)
• Support risk-based monitoring activities and identify potential risks impacting study quality or timelines
• Manage site financial activities including invoice collection and reconciliation
• Participate in co-monitoring and training visits while providing mentorship and guidance to clinical research staff
• Collaborate with cross-functional clinical operations, data management, quality, and project teams to support successful study execution

Qualifications for the Clinical Research Associate include:

• Bachelor's degree in a scientific discipline, healthcare, nursing, or related field preferred
• 3+ years of recent, independent onsite monitoring experience specifically within Oncology — required
• Recent hands-on experience monitoring oncology clinical trials involving solid tumors and/or liquid tumors
• Experience conducting Site Selection, Site Initiation, Routine Monitoring, and Close-Out Visits
• Experience supporting Phase I clinical trials
• Strong understanding of Good Clinical Practice (GCP) and ICH guidelines
• Demonstrated knowledge of oncology clinical trial protocols and monitoring requirements
• Experience with risk-based monitoring and clinical trial quality assurance
• Strong understanding of clinical trial documentation, regulatory submissions, TMF, and ISF requirements
• Excellent communication, organization, problem-solving, and time management skills
• Proficiency with Microsoft Office Suite and clinical trial technology platforms
• Ability to travel extensively to assigned clinical trial sites

Preferred Qualifications:

• Experience monitoring both solid and liquid tumor oncology studies
• Experience with hematologic malignancies including Non-Hodgkin Lymphoma, Hodgkin Lymphoma, Multiple Myeloma, or Leukemia
• Experience supporting CAR-T or other advanced oncology therapies
• Knowledge of RECIST and oncology tumor response assessment
• Understanding of target and non-target lesions and oncology imaging assessments
• Experience monitoring studies involving ANC and other oncology-specific laboratory assessments
• Experience with Phase I oncology studies in a CRO, pharmaceutical, or biotechnology environment
• Experience with quality assurance and clinical trial risk management

Compensation for the Clinical Research Associate includes:

• Salary: $110,000 - $135,000
• Comprehensive Benefits Package including Medical, Dental, Vision, 401(k), PTO, and Paid Holidays

#LI-MM1 #LI-REMOTE

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