Description
We are seeking a Clinical Research Site Manager to perform monitoring and site management work, ensuring sites conduct studies and report data according to study protocols, regulations, and sponsor requirements.
Essential Functions:
- Conduct site monitoring visits, including selection, initiation, monitoring, and close-out visits, following contracted scope of work and regulatory requirements
- Collaborate with sites to adapt, drive, and track subject recruitment plans, enhancing predictability
- Provide protocol and related study training to assigned sites, establishing regular communication lines to manage project expectations and issues
- Evaluate study site practices, escalating quality issues as needed
- Manage study progress, tracking regulatory submissions, recruitment, case report form completion, and data query resolution
- Ensure site documents are available for filing in the Trial Master File and verify Investigator's Site File maintenance
- Create and maintain documentation regarding site management, monitoring visit findings, and action plans
- Collaborate with study team members for project execution support
Qualifications:
- Bachelor's degree in a scientific discipline or healthcare
- At least 1 year of on-site monitoring experience
- Equivalent combinations of education, training, and experience may be accepted
- Good knowledge of clinical research regulatory requirements, including Good Clinical Practice and International Conference on Harmonization guidelines
- Therapeutic and protocol knowledge, provided through company training
- Computer skills, including Microsoft Word, Excel, and PowerPoint, and proficiency in using laptops and mobile devices
- Strong written and verbal communication skills, with good command of English
- Organizational, problem-solving, time, and financial management skills
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients