Clinical Research Associate (CRA) II (Medical device)

US Tech Solutions; United States; Remote; USD 70,000 - 90,000; Full time

Job summary

A leading company in the medical field is seeking a clinical team member to conduct Phase I-IV studies. The role involves planning, monitoring, and ensuring compliance with regulations. Ideal candidates will have medical device experience and strong communication skills.

Qualifications

• Experience with Phase I-IV clinical studies.
• Familiarity with Federal Regulations and ICH guidelines.

Responsibilities

• Conduct Phase I-IV clinical studies according to regulations.
• Assist in planning and managing study conduct.
• Monitor investigational sites for protocol adherence.

Skills

Medical Device Experience

Attention to Detail

Great Communication Skills

Phase IV Experience

Job description

Skills, Experience, or Education Required

• Medical Device Experience
• Attention to Detail
• Great Communication Skills
• Phase IV Experience

Description

• Member of the clinical team responsible for conducting Phase I-IV single or multi-center studies according to Federal Regulations and ICH guidelines.
• Assist senior staff in planning study conduct, designing case report forms (CRFs), selecting and managing Contract Research Organizations (CROs), selecting and training investigator sites, planning and running study meetings, evaluating and training new study investigators, and preparing submissions.
• Monitor or oversee the monitoring of investigational sites to ensure protocol adherence, timely patient enrollment, retrieval and processing of CRFs, data cleanup, classification, and completion of study summaries.