Clinical Research Associate Jobs

Position: Clinical Research Associate (North America)

Location: Remote

We are seeking a motivated and proactive Clinical Research Associate to join our clients team in North America. As a key member of our Clinical Operations division, you will play a vital role in various aspects of clinical trial management, ensuring the successful execution of trials. This is a remote position that offers flexibility and autonomy.

Responsibilities:

• Organize and participate in investigational meetings and site training as a representative of the assigned clinical trial.
• Support the Study Team/Management in all phases of the clinical trial.
• Ensure compliance with protocols, country regulations, Good Clinical Practice regulations, and internal Standard Operating Procedures.
• Evaluate and select investigative sites, if applicable.
• Conduct site monitoring for clinical trials, following our clients Standard Operating Procedures, ICH and GCP Guidelines.
• Contribute to trial operations, including internal metrics and effective communication of trial status within and outside the trial team.
• Maintain study-related supplies and investigational product inventory at assigned sites.
• Manage trial-specific Trial Master File (TMF) and internal filing system, including regulatory and legal document tracking and archiving.
• Perform co-monitoring visits as required.
• Assist in writing and reviewing clinical documents, such as informed consent forms, trial reports, and annual reports.
• Develop study-specific tools for communication and engagement with trial participants.
• Oversee site management responsibilities for assigned sites.
• Assist in the management of routine trial activities, adhering to industry and corporate standards.

Requirements:

• Highly motivated, with excellent interpersonal and written communication skills.
• Proficiency in computer skills, including MS Office (Word, Excel, PowerPoint) and internet research.
• Excellent record-keeping abilities.
• Ability to build and maintain positive relationships with trial staff.
• Willingness and ability to travel occasionally (10-20%).
• Knowledge of clinical research in Cardiology/Medical Devices
• Ability to work well under pressure and maintain composure.
• Capable of working independently on assigned tasks while collaborating effectively within a team.
• Effective organization and prioritization skills within a complex framework.
• Familiarity with Medical Device regulations or clinical trials.
• Strong critical thinking and problem-solving abilities.
• Positive attitude and approach.
• Understanding of US legislation governing clinical trials and Good Clinical Practice (GCP).
• Detail-oriented and process-driven.
• 2+ years of experience in a sponsor or CRO setting (strongly preferred).

Join our team and contribute to the advancement of clinical research in the field of medical devices. Apply your skills and expertise in a flexible and remote work environment. We look forward to reviewing your application and discussing the opportunity further.

Salary: $80,000 - $120,000 depending on experience