Sr Clinical Research Associate - Canada

About the role

The Sr Clinical Research Associate (CRA) will support clinical trials in Canada, focusing on both device and pharmaceutical studies. Specific examples include ablation catheters, pacemakers, ICDs, LAACs, stents, and valves for devices, and rhythm disorders and myocardial infarction for pharmaceuticals.

Responsibilities

• Manage contracts and budget negotiations with sites, providing regular updates to study leadership.
• Regularly meet with the Contract Specialist to discuss site statuses and address any unresponsiveness.
• Provide contract and budget updates to study leadership on a regular basis.
• Submit regulatory documents to sites, including informed consent forms (ICFs), and review and approve ICFs throughout the trial.
• Complete and send the Study Activation Checklist for signature by the study lead.
• Send enrollment activation letters to sites to confirm their authorization for participant enrollment.

Requirements

• A plus:
• CRA training or bridge program through a reputable organization or employer.
• Experience in clinical research.
• In-depth knowledge of applicable regulations and ICH/GCP guidelines.
• Strong problem-solving skills to mitigate risks and identify issues promptly.
• Excellent interpersonal skills to build and maintain relationships with site personnel, investigators, and internal teams.
• Exceptional verbal and written communication skills, capable of conveying complex information clearly and concisely.
• Ability to adapt communication styles to meet the needs of various stakeholders.
• Ability to work independently and manage multiple tasks in a fast-paced environment.
• A well-thought-out communication plan with study teams and sites.
• Proven experience in clinical trial management, demonstrating rigor, attention to detail, and precision in report writing.

Qualifications

• Advanced degree in a relevant field (e.g., Biomedical Engineering, Pharmacy, Medicine).
• Minimum 5 years of experience in clinical research, preferably in a regulatory environment.
• Knowledge of ICH/GCP guidelines and familiarity with Canadian regulatory requirements.
• Strong organizational and time management skills.
• Proficiency in Microsoft Office Suite.

Skills

• Strong problem-solving skills.
• Excellent interpersonal and communication skills.
• Ability to work independently and manage multiple tasks.
• Attention to detail and precision in report writing.

Benefits

Kelly offers a comprehensive range of benefits, including:

• Medical, dental, and vision insurance.
• Telemedicine services.
• Term life and whole life insurance.
• Accident insurance.
• Critical illness coverage.
• A legal plan.
• Short-term disability insurance.
• A retirement savings plan.
• Service bonus and holiday pay plans.
• A transit spending account.
• Paid sick leave.

Pay

$180/hr - $190/hr

Schedule

Contract position