Site Manager Job Richmond area,Virginia USA,Management

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: Regional Director

Job Description

Operational Planning
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
Clinic Operations Management –
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
Investigator Relationship –
Develop strong working relationships with Investigators
Works with Tekton Leaders
Ensure Investigator coverage for optimal site visits
Collaborate with investigator to ensure study success
Quality Control –
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
General –
Serves as team member of Tekton
Communicate effectively and professionally with other team members in a timely manner
Represent Tekton in a professional manner
Promote harmony and professionalism within the workplace
Acquire and maintain the following Tekton training:
Tekton Research, Inc. SOPs, processes, and policies – every year or as changes are made
Good Clinical Practice (GCP) – every 2 years
IATA Shipment of Hazardous Goods – (if applicable) every 3 years, or as directed
Participate in study-specific training as required
Study Coordinating and Recruitment (The following is listed for what is expected of site staff. This is listed here for sites where site managers are coordinating studies) –
Ensure site is prepared for study conduct
Ensures appropriate staff attends Investigator meeting and Site Initiation Visit
Ensure staff who will be participating on the trial are trained appropriately
Ensure source creation is completed and reviewed in a timely manner
Work with Regulatory Staff to manage essential documents
Complete site level Regulatory duties, including continuing reviews and study close outs
Disseminate information to other personnel, as well as to potential patients
Ensure all staff is trained according to tasks that will be delegated
Ensure site has obtained all…