Site Manager

Job Description

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.
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.

Investigator Relationship

Develop strong working relationships with Investigators.
Collaborate with investigator to ensure study success.

Quality Control

Manage site quality control process.
Monitor adherence to SOPs and take immediate corrective actions as necessary to ensure compliance.
Monitor site staff to ensure highest quality performance and adherence to Good Clinical Practice and FDA Regulations and guidance’s.
Take immediate corrective actions as necessary to ensure compliance.

General

Serve 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

Required Skills/Abilities

Must be able to communicate in verbal and written form effectively
Must be able to read or learn to read scientific language and generalize information
Must be willing and able to adhere to instructions and regulations
Demonstrate leadership skills

Education and Experience

3+ years’ experience in the Clinical Research Industry
Supervisory/management experience or demonstrated definitive leadership skills
Experience with regulatory processes, clinical procedures, sponsor interaction, and human resources preferred
College or Specialized Degree preferred

Physical Requirements

Must be able to lift up to 15 pounds at times
Must be able to commute between sites in areas with multiple locations
Must be available to travel as needed (