Clinical Research Site Director

$120,000 - $140,000/Yr

Wake Research Corporation - San Diego, CA

posted about 2 months ago

Full-time - Mid Level
San Diego, CA
11-50 employees
Administrative and Support Services

About the position

M3 Wake Research, an M3USA Company, is seeking a Clinical Research Site Director to oversee site activities and ensure the successful delivery of clinical trial targets. This position is based in San Diego, CA, and is 100% onsite. The Clinical Research Site Director will be responsible for managing all clinical and administrative aspects of clinical trials at the research site, ensuring compliance with regulatory standards and quality expectations. The role involves direct supervision of site staff and coordination of site activities to meet enrollment goals and maintain high standards of trial conduct. The Clinical Research Site Director will conduct site assessments, pre-trial evaluations, and site initiation activities. They will be responsible for subject recruitment and retention, monitoring subject visits, and ensuring that all necessary study supplies are available for trial conduct. The Director will also oversee the training and development of site staff, ensuring that they are well-versed in established key performance indicators (KPIs) and compliance with protocols and regulations. In addition to managing the day-to-day operations of the site, the Clinical Research Site Director will work closely with the corporate office to evaluate recruitment plans and study start-up processes. They will review budgets related to clinical research and physician costs, ensuring that the site operates within its financial parameters. The Director will also be involved in quality assurance and quality control programs, preparing the site for sponsor visits and ensuring that all monitoring standard operating procedures (SOPs) are followed. This role is critical in maintaining the integrity and success of clinical trials conducted at M3 Wake Research.

Responsibilities

  • Oversee site activities to ensure delivery of site targets as received from senior management.
  • Provide direct or indirect supervision of all clinical and administrative aspects of a clinical trial within the research site.
  • Conduct site assessments, pre-trial assessments, site initiation, subject recruitment and retention, monitoring and close-out.
  • Conduct pre-study site selection visits and assessments.
  • Ensure site study supplies are adequate for trial conduct.
  • Schedule staff to cover subjects' visit needs.
  • Conduct staff reviews and ensure enrollment goals are met.
  • Monitor subject visits and support the team and investigators in overall trial conduct.
  • Follow established monitoring SOPs and protocols for specific monitoring plans.
  • Work with QA/QC program prior to sponsor visit.
  • Oversee employees' work before monitoring and review budgets, including clinical research and physicians' costs.
  • Work with the corporate office to evaluate recruitment plans and study start-up processes.
  • Oversee protocol, regulations, and compliance training; ensure training is up to date.
  • Oversee the site financial performance and train and develop site staff.

Requirements

  • Bachelor's degree or equivalent and relevant formal academic experience.
  • Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA) or equivalent certification preferred.
  • 5+ years of relevant experience as a clinical research associate or clinical research coordinator required.
  • Experience managing trials is essential.
  • Knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs is required.
  • Solid teamwork, organizational, interpersonal, attention to detail, and problem-solving skills are necessary.
  • Strong written and verbal communication skills are essential.
  • Ability to consume, absorb, and analyze large amounts of information is required.
  • Ability to multi-task, work under time constraints, and work independently and cooperatively with interdisciplinary teams is necessary.
  • Strong computer skills in appropriate software and related company clinical systems are required.

Nice-to-haves

  • Experience with additional certifications in clinical research management.
  • Familiarity with advanced clinical trial management software.

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
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