Clinical Research Site Manager

4 days ago

Charleston, West Virginia, United States Wake Research Full time
Job Summary:

The Clinical Research Site Manager plays a pivotal role in ensuring the successful delivery of clinical trials within the research site. Reporting to senior management, this individual provides direct or indirect supervision to all clinical and administrative aspects of a clinical trial, guaranteeing the achievement of site targets and maintaining the highest quality standards.

Key Responsibilities:
  • Oversee site assessments, pre-trial assessments, site initiation, subject recruitment, and retention, as well as monitoring and close-out.
  • Conduct pre-study site selection visits and assessments to ensure site feasibility.
  • Ensure adequate site study supplies are available for trial conduct.
  • Schedule staff to meet subject visit needs and conduct regular staff reviews.
  • Monitor subject visits and support the team and investigators in the overall conduct of trials.
  • Follow established monitoring SOPs, corporate, and clinical, as well as protocol for specific monitoring plans.
  • Collaborate with the QA/QC program prior to sponsor visits and oversee employees' work before monitoring.
  • Review budgets, including clinical research and physicians' costs, and work with the corporate office to evaluate recruitment plans and study start-up.
  • Ensure protocol, regulations, and compliance training are up-to-date and oversee the site's financial performance.
  • Train and develop site staff to ensure they understand and perform according to established KPIs.

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.
  • 3+ years of relevant experience as a clinical research associate or coordinator, with a proven track record in managing trials.
  • Knowledge of FDA regulations, ICH-Good Clinical Practices (GCP), and ISOs.
  • Solid teamwork, organizational, interpersonal, attention to detail, and problem-solving skills.
  • Strong written and verbal communication skills, with the ability to consume, absorb, and analyze large amounts of information.
  • Ability to multi-task, work under time constraints, work independently, and cooperatively with interdisciplinary teams.
  • Strong computer skills in appropriate software and related company clinical systems.

About M3 Wake Research:

M3 Wake Research is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Our mission is to utilize the internet for a healthier world and more efficient healthcare systems. We strive to make a significant difference in healthcare and provide a unique opportunity for you to be at the cutting edge of innovation, shaping the future in a meaningful career. Our benefits package includes competitive wages, 401(k), 401(k) matching, dental insurance, disability insurance, employee assistance program, flexible spending account, health insurance, life insurance, paid time off, and vision insurance.

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