Site Director

Tekton Research Inc•Longmont, CO

1d•Onsite

About The Position

Tekton Research is a growth-oriented clinical research organization that conducts clinical trials to advance medical knowledge and improve patient care. The Site Director manages day-to-day site activities, optimizes site performance, and drives the site toward company goals. The role supports both sponsors and study participants by ensuring contractual obligations are met and work is completed to promote client satisfaction. The Site Director works with Tekton leaders to resolve issues that interfere with company goals and represents the organization and site professionally, ethically, and positively. The Site Director oversees operational planning, clinic operations, staff management and development, investigator relationships, site quality control, and—in sites where managers coordinate studies—study coordination and recruitment. The role ensures staff and investigators are prepared for awarded studies; site activities comply with protocols, FDA regulations, ICH guidelines, Good Clinical Practice, SOPs, and company policies; and study and recruitment goals are met. The Site Director reports to the VP, Clinical Operations. This is a full-time, exempt, onsite position. The role requires availability during business hours, the ability to work remotely when needed, occasional lifting of up to 15 pounds, commuting between sites in multi-location areas, and travel as needed (less than 20%).

Requirements

At least 5 years of experience in the clinical research industry.
Supervisory or management experience, or demonstrated definitive leadership skills.
Effective verbal and written communication skills.
Ability to read or learn to read scientific language and generalize information.
Willingness and ability to follow instructions and regulations.
Ability to work remotely and be available during business hours.
Ability to lift up to 15 pounds at times.
Ability to commute between sites in areas with multiple locations.
Availability to travel as needed, less than 20%.

Nice To Haves

Experience with regulatory processes, clinical procedures, sponsor interaction, and human resources.
College or specialized degree.

Responsibilities

Review awarded studies with the Principal Investigator and support informed decisions about which studies to conduct.
Work with Tekton leaders to determine staffing needs and ensure the site has adequate space, staff, and time to conduct studies effectively, particularly for recruitment and retention.
Manage clinic operations and work with Tekton leaders on staff management and upcoming studies.
Hire qualified staff, ensure they are trained and qualified for their roles, monitor performance, provide feedback, and hold staff accountable to role expectations.
Ensure staff and investigators are informed about awarded studies and comply with study protocols, FDA regulations, ICH guidelines, SOPs, company policies, and the Employee Handbook.
Monitor site quality and performance, identify needs, and develop solutions to optimize operations and study conduct.
Manage staff schedules and assist staff with study conduct and management as needed.
Work with Tekton leaders on discipline and human resources matters, including misconduct, policy violations, and workplace issues.
Develop strong working relationships with investigators, ensure investigator coverage for site visits, and collaborate with investigators to support study success.
Manage site quality control, monitor SOP adherence and staff performance, and take corrective action as needed to support compliance with Good Clinical Practice and FDA regulations and guidance.
Communicate with colleagues effectively, professionally, and promptly; promote workplace harmony and professionalism; and represent Tekton professionally.
Complete required Tekton SOP, process, and policy training annually or when changes are made; complete GCP training every two years; complete IATA hazardous-goods shipping training when applicable every three years or as directed; participate in study-specific training; and maintain required medical licenses and certifications.
Prepare the site for study conduct and ensure appropriate staff attend investigator meetings and site initiation visits and receive training appropriate to their delegated tasks.
Ensure source documents are created and reviewed on time, essential documents are managed with regulatory staff, and site-level regulatory duties—including continuing reviews and study closeouts—are completed.
Disseminate study information to personnel and potential patients; obtain required study documents and equipment; and ensure sponsor and IRB approvals are received.
Communicate promptly with sponsors and other study stakeholders, including vendors, the recruiting department, and other resources as needed; build relationships with sponsors and sponsor monitors.
Ensure study recruitment goals are met or exceeded and study activities are completed according to protocol, FDA regulations, ICH guidelines, and Tekton expectations.
Ensure case report forms are complete and accurate, data queries are completed efficiently, study documents are current and correctly filed, laboratory procedures are completed accurately, and study supplies are managed.
Ensure study closeout activities are completed efficiently.
Perform other duties as assigned.