Clinical Operations Specialist

We are seeking a proactive Clinical Operations Specialist to join our team. This role is essential for safeguarding the wellbeing of research subjects and ensuring all clinical procedures are executed with the highest standards of care and in full compliance with all protocols and regulatory guidelines.

Roles and Responsibilities

• Safeguard the wellbeing of research subjects in a medical capacity.
• Review study protocols and execute procedures in alignment with protocols and regulatory, health, and safety standards.
• Recruit and coordinate communication with clinical trial volunteers and patients, maintaining clear and effective communication throughout the study.
• Follow all applicable regulations globally and by region.
• Collaborate with cross-functional teams to develop study materials, including informed consent forms and study manuals.
• Monitor trial progress and address any issues that arise during the study.
• Provide organizational support and assist with administrative tasks as needed.
• Perform routine tasks with some deviation from standard practice, adapting to changing circumstances.
• Utilize broad knowledge of operational systems and practices to improve study processes and outcomes.

Skills Required

• Strong understanding of clinical research protocols and regulatory requirements.
• A minimum of 2 years of experience in clinical operations or a related field.
• High school diploma or equivalent is required; an Associate's degree or higher in a related field is preferred.
• Excellent communication and interpersonal skills.
• Strong organizational and time management abilities.
• Attention to detail and accuracy in documentation.
• The ability to work effectively in a team environment.
• Proficiency in Microsoft Office Suite and clinical trial management software.
• A Certified Clinical Research Coordinator (CCRC) or equivalent certification is preferred.
• Basic Life Support (BLS) certification is required.