Medical Device Clinical Research Associate

Science; Alameda, Northern (CA, KY); Híbrido; USD 120 000 - 145 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Competitive salary

Equity

Medical, dental, vision

Flexible vacation & holidays

Company-paid meals (onsite)

Resumo da oferta

Science is seeking a Clinical Research Associate (CRA) to lead start-up, monitoring, and close-out of US trials, ensuring subject safety and data integrity. The role serves as the main liaison with trial sites, ensuring adherence to protocol, FDA regulations, ISO 14155, and internal SOPs while identifying process improvements.

Travel up to 40% across the United States and occasional abroad is expected. Strong technical writing and CTMS/EDC proficiency are required to succeed.

Qualificações

• Bachelor’s degree in Life Sciences, Nursing or related field.
• 2+ years of direct field monitoring experience in medical devices.
• Familiarity with FDA 21 CFR Part 812 and GCP.
• Proficiency with CTMS, EDC and eTMF platforms.
• Strong technical writing skills for monitoring reports.
• Willingness to travel up to 40% across the US and occasionally abroad.

Responsabilidades

• Organize study start-up and close-out materials for US trials.
• Conduct full cycle of site visits (Pre-study, Initiation, Routine, Close-out).
• Review source documents for accuracy in CRFs and EDC.
• Track inventory of investigational devices at sites.
• Identify and report Adverse Events per FDA/IRB timelines.
• Audit regulatory documents and maintain TMF.
• Educate site staff on device tech and protocol nuances.
• Coordinate IRB submissions with Sponsor and sites.
• Maintain study/status databases for internal reporting.

Conhecimentos

Field monitoring

Technical writing

Remote work capable

Process improvement mindset

Ownership mindset

Clinical trial monitoring

GCP familiarity

Formação académica

Bachelor’s degree in Life Sciences or Nursing

Ferramentas

CTMS

EDC

eTMF

Descrição da oferta de emprego

Science is seeking a Clinical Research Associate (CRA) to lead start-up, monitoring, and close-out of US trials, ensuring subject safety and data integrity. The role serves as the main liaison with trial sites, ensuring adherence to protocol, FDA regulations, ISO 14155, and internal SOPs while identifying process improvements.

Travel up to 40% across the United States and occasional abroad is expected. Strong technical writing and CTMS/EDC proficiency are required to succeed.