Clinical Operations Specialist

Clinical Operations Specialist

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.