Description
We are seeking a Clinical Research Monitor to perform monitoring and site management work, ensuring sites conduct studies and report data according to protocols, regulations, and sponsor requirements.
Responsibilities:
- Conduct site monitoring visits, including selection, initiation, monitoring, and close-out visits, following Good Clinical Practice guidelines
- Collaborate with sites to develop and track subject recruitment plans, enhancing predictability
- Provide protocol and study-related training to assigned sites and establish communication channels to manage project expectations and issues
- Evaluate study site practices, identifying quality issues and escalating as needed
- Manage study progress, tracking regulatory submissions, recruitment, case report form completion, and data query resolution
- Maintain site documents, Trial Master Files, and Investigator's Site Files according to GCP and local regulations
- Create and maintain documentation, including visit reports, follow-up letters, and study records
- Liaise with study team members to support project execution
Qualifications:
- Bachelor's degree in a scientific discipline or healthcare (preferred)
- At least 3 years of on-site monitoring experience
- Knowledge of clinical research regulatory requirements, Good Clinical Practice, and International Conference on Harmonization guidelines
- Proficiency in Microsoft Word, Excel, and PowerPoint, with laptop and mobile device skills
- Strong written and verbal communication skills, with good command of English
- Organizational, problem-solving, time management, and financial management skills
- Ability to establish effective working relationships with coworkers, managers, and clients
The potential base pay range for this role, when annualized, is $74,500.00 - $197,500.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time).