CRA II — Medical Device Clinical Trials

Avania LLC.; United States; Sur place; USD 90 000 - 110 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Benefits

Résumé du poste

Avania is seeking a Clinical Research Associate II (CRA II) for Medical Device clinical trials in the United States. The role requires 2+ years of CRA experience, including MedTech/Medical Device and cardiovascular projects, and involves travel for site visits and monitoring.

The CRA II will ensure rights and wellbeing of subjects, adherence to ISO14155/ICH-GCP, and accurate reporting of trial data. Competitive salary with bonus and benefits available.

Qualifications

• 2+ years CRA experience, including MedTech/Medical Device and Cardiovascular experience.
• Experience with ICH-GCP and ISO14155 regulatory requirements.

Responsabilités

• Oversee clinical trial monitoring at investigational sites with travel for SIVs and visits.
• Write accurate visit reports per SOPs/GCP; conduct pre-study, initiation, routine monitoring, and close-out visits.
• Guide investigators and study coordinators in conducting trials per protocols.
• Perform SDV and ensure data consistency with source documents.
• Collaborate with analytical teams to obtain clean data and resolve queries.
• Prepare for audits/inspections and participate in TMF reviews.

Description du poste

Avania is seeking a Clinical Research Associate II (CRA II) for Medical Device clinical trials in the United States. The role requires 2+ years of CRA experience, including MedTech/Medical Device and cardiovascular projects, and involves travel for site visits and monitoring.

The CRA II will ensure rights and wellbeing of subjects, adherence to ISO14155/ICH-GCP, and accurate reporting of trial data. Competitive salary with bonus and benefits available.