Clinical Research Site Manager (Longmont, CO)

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 –
  • Work closely with Tekton Leaders regarding staff management

• Demonstrate knowledge of research, Tekton expectations, and industry standards
• 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–
  • Works with Tekton Leaders

• Develop strong working relationships with Investigators
• 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
• Maintain medical license(s), certifications, etc

• 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 required documents and equipment to conduct study
• Ensure site has received sponsor and IRB approval
• Communicate with the sponsor in a timely manner
• Communicate with others involved with/in the study, such as vendors, recruiting department and other resources as needed
• Ensure recruitment goals for all studies are met or exceed
• Ensure all study-related activities are completed per protocol. FDA regulations, ICH guidelines, and Tekton expectations
• Ensure information is entered into case report forms completely and accurately
• Develop relationships and communicate with sponsors and sponsor monitors
• Ensure data queries are completed efficiently
• Ensure study documents are complete, current and filed correctly
• Ensure laboratory procedures are completed accurately
• Manage study supplies
• Ensure study closeout activities are completed efficiently
• Other duties as assigned

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
• Must 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