Clinical Research Site Manager

Wake Research Corporation - Tucson, AZ

Full-time - Mid Level

Tucson, AZ

11-50 employees

Administrative and Support Services

About the position

The Clinical Research Site Manager at M3 Wake Research is responsible for overseeing site activities to ensure the successful delivery of clinical trial targets. This role involves direct or indirect supervision of all clinical and administrative aspects of trials, ensuring compliance with regulations and quality standards. The position requires strong leadership and organizational skills to manage site operations effectively and support the research team in achieving enrollment goals and maintaining high standards of trial conduct.

Responsibilities

• Oversee site activities to ensure delivery of site targets as received from senior management.
• Conduct site assessments, pre-trial assessments, and site initiation.
• Manage subject recruitment and retention efforts.
• Monitor subject visits and ensure enrollment goals are met.
• Conduct pre-study site selection visits and assessments.
• Ensure adequate site study supplies for trial conduct.
• Schedule staff to cover subjects' visit needs and conduct staff reviews.
• Support the team and investigators in the overall conduct of trials.
• Follow established monitoring SOPs and specific monitoring plans.
• Work with QA/QC programs prior to sponsor visits.
• Review budgets, including clinical research and physicians' costs.
• Evaluate recruitment plans and study start-up with the corporate office.
• Oversee protocol, regulations, and compliance training for site staff.
• Train and develop site staff to understand and perform according to established KPIs.

Requirements

• Bachelor's degree or equivalent and relevant formal academic experience.
• 3+ years of relevant experience as a clinical research associate or clinical research coordinator.
• Experience managing clinical trials.
• Knowledge of FDA regulations, ICH-Good Clinical Practices (GCP), and ISOs.
• Strong written and verbal communication skills.
• Ability to analyze large amounts of information and multi-task under time constraints.
• Solid teamwork, organizational, interpersonal, attention to detail, and problem-solving skills.
• Strong computer skills in appropriate software and related company clinical systems.

Nice-to-haves

• Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Associate (CCRA) certification preferred.

Benefits

• 401(k)
• 401(k) matching
• Dental insurance
• Disability insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance