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Assistant Manager

Position: Assistant Site Manager (Full-Time/Exempt)

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.

Reports to: Site Manager

Job Description:

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

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

Physical Requirements: