Assistant Manager

Tekton Research Inc•Fort Collins, CO

41d

About The Position

Responsible for assisting the Site Manager to effectively manage day-to-day site activities for optimization of site performance as well as overall company goals. The Assistant Site Manager is responsible for ensuring contractual obligations are met and the work is completed in a manner that leads to both sponsor and participant satisfaction. It is the responsibility of the Assistant Site Manager 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.

Requirements

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
3+ years’ experience in the Clinical Research Industry
Supervisory/management experience or demonstrated definitive leadership skills

Nice To Haves

Experience with regulatory processes, clinical procedures, sponsor interaction, and human resources preferred
College or Specialized Degree preferred

Responsibilities

Support Operational Planning
Participate in protocol review, feasibility process, and study selection involving the PI in these processes to maximize protocol awards, enrollment success, and company growth.
Work with Tekton Leaders to make informed decisions regarding site staffing and cost control.
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 and performance, this includes: Leading, managing, and holding staff accountable.
Demonstrate knowledge of research, Tekton expectations and standard operating procedures, core values, and industry standards
Lead staff in continued growth and excellent performance
Assist with hiring quality candidates for positions within the site
Assist with ensuring site staff are 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
Assist with ensuring staff complies with study protocols, FDA regulations, and ICH guidelines
Assist with ensuring staff complies with SOPs and other Tekton policies and processes
Monitor site quality and performance and develop solutions to optimize performance
Assist with monitoring study needs and assist staff with study conduct and management, as needed
Manage staff schedules for optimization of site performance
Assist with site staff development
Take on leadership responsibilities for designated projects or initiatives, including guiding junior staff and coordinating workflow among team members to achieve project objectives.
Provides performance feedback to 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
Contribute to and ensure completion of site quality control processes
Guide site staff on required adherence to SOPs and takes immediate corrective actions as necessary to ensure compliance
Assist with monitoring 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
Communicate effectively and professionally with other team members in a timely manner
Represent Tekton in a professional manner onsite or when traveling on Tekton business Promoting professionalism within the workplace to all staff
Acquire and maintain the following Tekton training: Tekton Research SOPs, processes, and policies as required by Quality Assurance Department
Good Clinical Practice (GCP) – every 3 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
Maintain or work towards obtaining Clinical Research Certification (ie: CCRC, CCRP, etc).
Study Coordinating and Recruitment Ensure site is prepared for study conduct
Ensures appropriate staff attends Investigator meetings and Site Initiation Visits
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 participants
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 exceeded
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