Clinical Research Associate II - Psychiatry - United States (Remote)

Worldwide Clinical TrialsCarolina, NC
$79,500 - $158,500Remote

About The Position

We are looking for a CRA II who is eager to expand their monitoring expertise, build strong site relationships, and grow into a senior clinical operations role. This position is ideal for someone who has established a solid foundation in site monitoring and is ready to accelerate their career within a supportive, collaborative, and quality-focused organization. As a CRA II, you will play a critical role in ensuring the successful execution of clinical trials by performing on-site and remote monitoring visits in accordance with protocol, GCP, ICH guidelines, and company SOPs. You will build strong relationships with investigative sites and serve as a trusted partner, reviewing source documents and verifying data accuracy. You will also identify risks, issues, and trends at sites and proactively drive resolution, support site activation, enrollment, maintenance, and closeout activities, and ensure patient safety, data integrity, and protocol compliance. Additionally, you will prepare detailed monitoring reports and follow-up letters, and collaborate cross-functionally with CTMs, project teams, and site personnel.

Requirements

  • 2 - 3 years of experience as a regional, traveling Clinical Research Associate
  • 4-year university degree OR Nursing Degree
  • Knowledge of ICH-GCP guidelines and regulatory requirements
  • Experience conducting monitoring visits across multiple sites
  • Strong organizational, communication, and problem-solving skills
  • Ability to manage priorities in a fast-paced environment
  • Experience in Psychiatry is required
  • Willingness to travel regionally required

Nice To Haves

  • Experience in a CRO environment
  • Exposure to multiple therapeutic areas
  • Experience with decentralized or hybrid trial models
  • Desire to take on increasing responsibility and grow within Clinical Operations

Responsibilities

  • Performing on-site and remote monitoring visits in accordance with protocol, GCP, ICH guidelines, and company SOPs
  • Building strong relationships with investigative sites and serving as a trusted partner
  • Reviewing source documents and verifying data accuracy
  • Identifying risks, issues, and trends at sites and proactively driving resolution
  • Supporting site activation, enrollment, maintenance, and closeout activities
  • Ensuring patient safety, data integrity, and protocol compliance
  • Preparing detailed monitoring reports and follow-up letters
  • Collaborating cross-functionally with CTMs, project teams, and site personnel

Benefits

  • Competitive benefits package depending on location
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