Healthcare Compliance Officer

About the role

The Clinical Operations Specialist will support the operational aspects of clinical trials. Key responsibilities include managing trial logistics, ensuring compliance with protocols, and assisting with data collection. You will work closely with clinical teams to facilitate smooth trial execution.

Responsibilities

• Support clinical operations in various projects
• Assist in the development of operational strategies
• Monitor project timelines and deliverables
• Collaborate with external vendors
• Lead and manage clinical research projects
• Develop study protocols and budgets
• Ensure compliance with ethical standards
• Mentor junior staff and researchers
• Coordinate daily operations of clinical trials
• Assist in patient recruitment and retention
• Maintain study documentation and records
• Facilitate communication between teams
• Oversee data management processes for clinical trials
• Ensure data integrity and accuracy
• Collaborate with cross-functional teams
• Prepare data reports for stakeholders
• Manage clinical trials from initiation to completion
• Ensure compliance with regulatory requirements
• Coordinate with investigators and site staff
• Monitor patient recruitment and data collection

Requirements

• Bachelor's degree in Health Sciences, Life Sciences, Nursing, or related field
• Master’s degree in a relevant field (for Clinical Research Manager)
• PhD in Clinical Research or related field (for senior roles)
• Bachelor’s degree in Computer Science or related field (for Clinical Data Manager)
• 1+ years of experience in clinical trials or clinical operations
• 2+ years of experience in clinical operations, research, or project management
• 3+ years of experience in data management
• 5+ years of experience in clinical research management

Skills

• Strong organizational and multitasking skills
• Ability to work independently and as part of a team
• Strong leadership and project management skills
• Excellent problem-solving abilities
• Strong interpersonal skills
• Ability to work in a fast-paced environment
• Proficiency in statistical software
• Excellent analytical skills
• Strong communication and organizational skills
• Knowledge of GCP and FDA regulations
• Familiarity with clinical trial processes
• Experience with clinical data management software
• Attention to detail
• Familiarity with regulatory requirements