Research Associate
7 days ago
**About the Role**
We are seeking a highly skilled Clinical Research Associate to join our team at McInnis Inc. As a key member of our clinical research operations, you will play a critical role in supporting the execution of clinical trials.
**Key Responsibilities:**
- Act as the primary point of contact with assigned clinical study sites during start-up activities;
- Drive contract and budget negotiations (or amendments) with assigned sites, working closely with finance and legal experts;
- Review site-level documents needed for IRB/EC/REC approval;
- Support study initiation, monitoring, audit, and close-out phases of assigned clinical trials as prescribed in the sponsor SOPs and study monitoring plan;
- Ensure clinical study site documentation compliance according to GCPs, ICH, and FDA regulations;
- Provide timely study subject updates to the Clinical Study Manager(s);
- Facilitate communication flow between clinical study sites, sponsor, and vendors;
- Troubleshoot and provide solutions to study-related issues;
- Assist with patient recruitment activities;
**Requirements:**
- Bachelor's degree in nursing, health sciences, or related field;
- Minimum two years of CRA experience, preferably with clinical site monitoring experience;
- Strong oral and written communication skills;
- Good understanding of FDA regulations, GCPs, and ICH Guidance;
- Proven organizational skills and ability to manage multiple priorities;
- Strong computer skills;
- Ability to travel with adequate prior notification.
**Salary Information:** The estimated salary for this position is $60,000-$80,000 per year, depending on experience.
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