Clinical Research Associate 1

Job summary

This role involves monitoring and managing clinical study sites to ensure compliance with study protocols, regulations, and sponsor requirements. Responsibilities include conducting site visits, managing subject recruitment plans, and ensuring the integrity of study practices.

Qualifications

• Bachelor's Degree in a scientific discipline or healthcare preferred, or equivalent experience.
• Completion of CRA training program or prior monitoring experience may be required by some organizations.
• Basic knowledge of clinical research regulatory requirements (GCP and ICH guidelines).
• Proficient in Microsoft Word, Excel, and PowerPoint, and capable of using laptops and mobile devices.
• Strong written and verbal communication skills in English.
• Good organizational and problem-solving abilities.
• Effective time and financial management skills.
• Ability to build and maintain effective working relationships.

Responsibilities

• Conduct site monitoring visits including selection, initiation, monitoring, and close-out.
• Collaborate with sites to enhance subject recruitment plans.
• Administer study training and maintain communication with sites.
• Evaluate site practices for protocol adherence and escalate quality issues as necessary.
• Track study progress including regulatory submissions, recruitment, and data management.
• Ensure proper documentation for site management and monitoring findings.

Skills

• Strong knowledge of therapeutic areas and protocols as provided in training.
• Proficient in time and financial management.

Education

• Bachelor's Degree in a scientific discipline or healthcare preferred, or equivalent experience accepted.

Tools

• Microsoft Word, Excel, PowerPoint, laptop, iPhone, and iPad.