Clinical Research Site Manager
About Tekton Research
Tekton Research is a growth-oriented clinical research organization committed to conducting high-quality clinical trials that advance medical knowledge and improve patient care. We are a collaborative, values-driven team that believes in Focus, Discipline, and Accountability. At Tekton Research, we take pride in doing excellent work while fulfilling our mission of Making Life Better. We offer competitive compensation, comprehensive benefits, and opportunities for professional growth in a supportive and fast-paced research environment.
Position Summary
The Site Manager is responsible for effectively managing day-to-day site activities for optimization of site performance. The Site Manager is responsible for driving the site to achieve company goals. Our clients are twofold, the sponsor and the participant. The Site Manager is responsible for ensuring contractual obligations are met and work is completed in a manner that leads to client satisfaction. It is the responsibility of the Site Manage to work with Tekton Leaders to problem solve issues that may arise that interfere with achieving company goals. It is imperative to represent himself/herself and the site in the most professional, ethical and positive manner. Reports to: Area Director of Clinical Operations
Responsibilities
- Review and discuss awarded studies with the Principal Investigator to assist Tekton Leaders in making informed decisions about what studies to conduct
- Work with Tekton Leaders to make informed decisions regarding new staff needs for successful study conduct
- Work with Tekton Leaders to ensure site has proper space, staff, and time to optimize study conduct, particularly participant recruitment and retention
- Demonstrate knowledge of research, Tekton expectations, and industry standards
- Work closely with Tekton Leaders regarding staff management
- Lead staff in continued growth and excellent performance
- Hire quality candidates for positions within the site
- Ensure site staff is qualified and trained for roles and duties
- Work with Tekton Leaders to plan for upcoming studies
- Ensure site staff and investigators are apprised of awarded studies
- Monitor staff performance, holding staff accountable to expectations of role
- Ensures staff complies with study protocols, FDA regulations, and ICH guidelines
- Ensures staff complies with SOPs and other Tekton policies and processes
- Monitor site quality and performance and develop solutions to optimize performance
- Monitor study needs and assist staff with study conduct and management, as needed
- Manage staff schedules for optimization of site performance
- Provides performance feedback to staff
- Work with Tekton Leaders to manage discipline, as necessary, HR issues, such as misconduct, violations of company policy, office turmoil, etc of coordinating staff
- Ensure staff compliance with company Employee Handbook
- Develop strong working relationships with Investigators
- Works with Tekton Leaders
- Ensure Investigator coverage for optimal site visits
- Collaborate with investigator to ensure study success
- Manage site quality control process
- Monitors adherence to SOPs and takes immediate corrective actions as necessary to ensure compliance
- Monitors site staff to ensure highest quality performance and adherence to Good Clinical Practice and FDA Regulations and guidance’s.
- Takes immediate corrective actions as necessary to ensure compliance
- Serves as team member of Tekton
- Communicate effectively and professionally with other team members in a timely manner
- Represent Tekton in a professional manner