CRA

Clinical Research Associate (CRA)

Meet Life Sciences is representing a client seeking a Clinical Research Associate (CRA) to support the operational management and oversight of clinical study monitoring activities. This individual will work closely with internal Clinical Operations leadership, CRO partners, field-based CRAs, and clinical study sites to ensure trials are executed efficiently, compliantly, and in alignment with study timelines and quality expectations.

Travel Requirement: Must be willing to travel domestically and internationally, approximately 20–25%, as needed.

Primary Responsibilities

• Assist the Clinical Trial Manager in ensuring clinical trials are initiated efficiently, completed on time and within budget, and conducted in compliance with SOPs, regulations, and ICH/GCP guidelines.
• Support the Clinical Trial Manager in managing CRO partners and other external vendors.
• Work closely with and provide training to CRO staff, study site staff, and field-based CRAs.
• Oversee, conduct, and/or co-monitor site qualification, study initiation, interim monitoring, and close-out visits, including completion of associated reports.
• Develop and/or assist in the development of trial materials, including protocols, informed consent forms, case report forms, CRF completion guidelines, monitoring guidelines, site initiation visit materials, site tools and worksheets, and product administration guidelines.
• Review monitoring reports and monitoring visit letters prepared by CRO CRAs.
• Drive CRO and trial sites through study start-up activities, including IRB/IEC submissions and collection/review of required essential documents.
• Create, monitor, and share key performance metrics with study teams.
• Review completed CRFs and data listings for accuracy, oversee data discrepancy management, and provide associated training/retraining to site staff and CRAs as needed.
• Develop strong and effective working relationships across Clinical Operations, other functional departments, CROs, and external study partners.

Qualifications and Requirements

• BS/BA in life sciences or a related discipline.
• 5+ years of pharma/biopharma industry experience, preferably within a sponsor-side environment.
• 1+ years of active, independent, on-site monitoring experience across all visit types.
• Strong working knowledge of FDA regulations, ICH/GCP guidelines, and clinical monitoring procedures.
• Thorough understanding of clinical trial monitoring, study start-up, site management, and essential document review.
• Strong interpersonal, written/verbal communication, and organizational skills.
• Excellent analytical, assessment, judgment, and problem-solving abilities.