Clinical Research Associate II (Pharmaceuticals, Remote/Office)

Job summary

This role involves performing and coordinating all aspects of clinical monitoring and site management for clinical trials. The Clinical Research Associate 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 life sciences or equivalent nursing certification.
• At least 1 year of experience as a clinical research monitor or completion of a relevant fellowship.
• Valid driver's license where applicable.

Responsibilities

• Monitor investigator sites using a risk-based approach, applying critical thinking and problem-solving to ensure compliance and data accuracy.
• Conduct on-site and remote monitoring activities, documenting observations and escalating issues as needed.
• 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 trial status updates to the Clinical Team Manager and maintain study systems.
• Facilitate communication between investigative sites and project teams.
• Complete administrative tasks such as expense reports and timesheets.

Skills

• Proven clinical monitoring skills and understanding of medical terminology.
• Strong critical thinking and problem-solving abilities.
• Excellent oral and written communication skills.
• Good organizational and time management skills.
• Ability to work independently or as part of a team.
• Proficient in Microsoft Office and other relevant software.
• Strong attention to detail and adaptability.

Education

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

Tools

• Microsoft Office and Clinical Trial Management Systems.