Join our team as a Clinical Research Site Manager, where you’ll play a crucial role in ensuring our study sites operate seamlessly and adhere to all protocols, regulations, and sponsor requirements.

Essential Functions

• Site Monitoring:Conduct selection, initiation, monitoring, and close-out visits in line with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Recruitment Management:Collaborate with sites to develop, drive, and track recruitment plans, enhancing predictability and meeting project needs.
• Training & Communication:Provide protocol training and maintain regular communication with sites to manage expectations and address issues.
• Quality Assurance:Evaluate site practices for protocol adherence and escalate quality issues as needed.
• Study Progress:Track regulatory submissions, recruitment, enrollment, case report form (CRF) completion, and data query resolution. Support the start-up phase as required.
• Documentation:Ensure all site documents are filed in the Trial Master File (TMF) and Investigator’s Site File (ISF) according to GCP/ICH and local regulations.
• Mentorship:Mentor clinical staff through co-monitoring and training visits.
• Collaboration:Work closely with study team members to support project execution.
• Travel: 6-10 DoS per month typical expectation, can be exceptions given the nature of the position.

Qualifications

• Education:BS Degree in a scientific discipline or healthcare preferred.
• Experience:At least 2.5 years of on-site monitoring experience, with a preference for oncology or immunology.
• Knowledge:In-depth understanding of GCP and ICH guidelines.
• Skills:Proficiency in Microsoft Word, Excel, and PowerPoint, and adept at using laptops, iPhones, and iPads.
• Communication:Strong written and verbal communication skills with a good command of the English language.
• Organization:Excellent organizational and problem-solving skills.
• Management:Effective time and financial management abilities.
• Interpersonal:Ability to establish and maintain effective working relationships with coworkers, managers, and clients.