Research Associate

7 days ago


Ridgefield, Connecticut, United States McInnis Inc. Full time

**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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