Clinical Research Associate

This is a fully remote position, open to applicants in Canada.

📋 Description

• Conducts site qualification, initiation, interim monitoring, management, and close-out visits (either on-site or remotely) to ensure compliance with regulatory standards, ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and study protocols.

• Utilizes judgment and expertise to assess the overall performance of sites and their staff, providing recommendations for site-specific actions; promptly communicates or escalates serious issues to the project team and formulates action plans.

• Maintains a comprehensive understanding of ICH/GCP Guidelines or other relevant guidance, applicable regulations, and company standard operating procedures (SOPs) and processes.

• Ensures that the process of obtaining informed consent is thoroughly executed and documented for each subject or patient as necessary.

• Exhibits diligence in safeguarding the confidentiality of all subjects or patients.

• Evaluates factors that could impact subject or patient safety and the integrity of clinical data at investigator or physician sites, such as protocol deviations, violations, and pharmacovigilance concerns.

• Conducts Source Document Reviews of relevant site source documents and medical records.

• Confirms that the required clinical data recorded in the case report form (CRF) is accurate and complete through reviews of site source documents and medical records.

• Implements query resolution techniques both remotely and on-site.

• Leverages available hardware and software to facilitate effective clinical study data review and capture.

• Ensures that sites comply with electronic data capture requirements.

• Aids in recruitment, retention, and awareness strategies for subjects or patients.

⛳️ Requirements

• Bachelor’s degree or Registered Nurse (RN) in a related field, or an equivalent combination of education, training, and experience.

• Familiarity with Good Clinical Practice/ICH Guidelines and other relevant regulatory requirements.

• Must demonstrate proficient computer skills and a willingness to adopt new technologies.

• Exceptional communication, presentation, and interpersonal skills are essential.

• A foundational level of critical thinking skills is expected.

• Capability to manage necessary travel of up to 75% on a regular basis.

🏝️ Benefits

• Health insurance.

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition.

• Total rewards program.

• Flexibility in working hours.