Sr Associate, Field Clinical Monitoring; U.S. Remote

Sr Associate, Field Clinical Monitoring (U.S. Remote)

Posted Mar 10
• Full‑time

Full‑time position located in Aliso Viejo, California, USA (U.S. Remote).

Responsibilities:

• Identify, develop, and maintain investigators and sites capable of delivering start‑up goals, enrollment targets, and required data quality.
• Facilitate and maintain open communication among investigational sites, study and data management teams, and the company. Ensure effective communication with key stakeholders.
• Ensure clinical studies are conducted in accordance with the protocol, GCP, company SOPs, and all applicable regulations (e.g., FDA).
• Understand, read, prepare, and deploy study documentation including informed consents, study forms, and study training documents.
• Collect and review essential documents, facilitate necessary corrections, and file in assigned system(s).
• Maintain device accountability records.
• Review data and source documentation from investigational sites for accuracy and completeness; facilitate resolution of data queries and manage action items to completion.
• Conduct and perform site initiation visits, site training, interim monitoring visits, and close‑out visits.
• Maintain accurate, detailed, and complete records of monitoring visits and reporting findings according to plans and processes.
• Collaborate with sites to ensure adherence to compliance requirements and escalates non‑compliance when necessary.
• Draft study‑specific Monitoring Plans in collaboration with a Project Manager and Clinical Quality Assurance.
• Assume Lead Clinical Research Associate responsibilities on assigned studies, including reporting of monitoring KPIs.
• Serve as a mentor to more junior Field Monitors.
• Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements, and demonstrate ethics and integrity in all matters.
• Perform additional duties as assigned.

Qualifications:

• Bachelor's degree in a related field (preferably Life Science) or equivalent combination of education and experience.
• Minimum six (6) years of medical device monitoring experience.
• Minimum four (4) years of neurovascular experience.
• Strong knowledge of FDA regulations for clinical trials and clinical procedures.
• Strong collaborative skills with demonstrated ability to work with physicians, site coordinators, and others within the company.
• Experience using technologies for clinical research (electronic data capture and clinical trial management systems).
• Excellent written and verbal communication skills.
• Strong computer skills including MS Office (Word, Excel, Access, PowerPoint, Outlook, Teams).

Desired

Qualifications:

• Proven clinical research expertise in various therapeutic areas.
• Experience in a catheter lab environment.

EEO Statement:

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law.

Salary Range: $111,000 – $146,000 (Financial compensation may vary based on experience, equity, skill set, geography, education, business needs and market demand.)