Sr. Clinical Research Associate (Field)

About the role

We are seeking one field-based Senior Clinical Research Associate (Senior CRA) who will play a critical role in monitoring and managing clinical trial site activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards.

Responsibilities

• Serve as the primary point of contact for investigative sites, fostering strong and collaborative site relationships.
• Monitor patient data and clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Lead and conduct on-site and remote monitoring visits (site qualification, initiation, monitoring, and close-out) to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Critically review clinical data to ensure accuracy, completeness, and integrity in alignment with EDC systems and clinical data management standards.
• Engage site staff in development of enrollment targets, tracking enrollment progress, and troubleshooting patient recruitment issues.
• Provide training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Maintain oversight of investigational product accountability, tracking, and reconciliation for cardiovascular devices.
• Partner closely with internal stakeholders to align clinical activities with business and regulatory objectives.
• Identify, document, and assist in resolving protocol deviations and CAPAs.
• Participate in internal audits and support readiness for regulatory inspections.

Skills & Hands-On Experience

• Strong working knowledge of GCP, ISO 14155 and FDA guidelines.
• Proficient in EDC, eTMF, and Microsoft Office tools.
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.

Requirements

Preferred geographic locations: GA, NC, SC, TN, or TX.

Qualifications

• Bachelor’s degree in life sciences, nursing, biomedical engineering, or related discipline.
• 5+ years of experience in clinical research, including at least 3 years of independent monitoring for medical device trials.
• Experience in IDE studies strongly preferred.
• Prior experience in cardiovascular or interventional device studies strongly preferred.

Skills

• Strong working knowledge of GCP, ISO 14155 and FDA guidelines.
• Proficient in EDC, eTMF, and Microsoft Office tools.
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.

Benefits

The base salary range for this full-time position is between $120,000 - $140,000 + equity + benefits.