Description
We are seeking a Clinical Research Site Manager to perform monitoring and site management work, ensuring sites conduct studies and report study data as required by the study protocol, regulations, and sponsor requirements.
Responsibilities:
- Conduct site monitoring visits in accordance with contracted scope of work and regulatory requirements
- Collaborate with sites to adapt, drive, and track subject recruitment plans
- Provide protocol and related study training to assigned sites and establish regular communication lines
- Evaluate study site practices and escalate quality issues as needed
- Manage study progress by tracking regulatory submissions, recruitment, CRF completion, and data query resolution
- Maintain site documents and verify Investigator's Site File in accordance with GCP and local regulatory requirements
- 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 preferred
- At least 1 year of on-site monitoring experience
- Knowledge of applicable clinical research regulatory requirements (GCP and ICH guidelines)
- Good therapeutic and protocol knowledge
- Proficiency in Microsoft Word, Excel, and PowerPoint, and use of a laptop computer and iPhone and iPad
- Excellent written and verbal communication skills, including good command of English
- Organizational, problem-solving, and time and financial management skills
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients