Clinical Research Associate II (Remote)

Job summary

This role involves performing and coordinating all aspects of clinical monitoring and site management processes for clinical trials. The Clinical Research Associate (Level II) will conduct remote or on-site visits to ensure compliance with protocols and regulations, manage documentation, and maintain relationships with investigational sites.

Qualifications

• Bachelor's degree in a life sciences field or equivalent nursing certification.
• Previous experience in clinical research monitoring (approximately 1 year) or completion of a relevant fellowship.
• Valid driver's license where applicable.

Responsibilities

• Monitor investigator sites using a risk-based approach, ensuring compliance and data accuracy through various review processes.
• Conduct regular communication with investigative sites to confirm protocol adherence and resolve identified issues.
• Participate in investigator meetings and assist in site initiation and trial close-out processes.
• Ensure essential documents are complete and compliant with ICH-GCP and regulations.
• Provide updates on trial status to the Clinical Team Manager and maintain study systems.
• Facilitate communication between sites, clients, and project teams.
• Complete administrative tasks such as expense reports and timesheets.
• Contribute to project publications and process improvement initiatives.

Skills

• Proven clinical monitoring skills and understanding of medical terminology.
• Strong critical thinking and problem-solving abilities.
• Excellent oral and written communication skills in English.
• Good organizational and time management skills.
• Ability to work independently or as part of a team.
• Proficiency in Microsoft Office and ability to learn new software.

Education

• Bachelor's degree in a life sciences related field or equivalent nursing certification.

Tools

• Clinical Trial Management Systems, Microsoft Office.