Clinical Research Site Manager

3 weeks ago


Orange, United States Medix™ Full time

Overview: We are seeking an experienced and dedicated Research Site Manager to oversee the operations of our clinical research site. The ideal candidate will have at least 2 years of experience in clinical research management, with a strong preference for experience in therapeutic areas such as NASH (Non-Alcoholic Steatohepatitis), Obesity, Cancer, or CNS (Central Nervous System) disorders.


Key Responsibilities:

  • Oversee the day-to-day operations of the clinical research site, ensuring that all activities comply with study protocols, regulatory requirements, and Good Clinical Practice (GCP).
  • Manage a team of clinical research coordinators, providing guidance, training, and support to ensure high-quality performance.
  • Collaborate with investigators, sponsors, and CROs to ensure the successful execution of clinical trials from start-up to close-out.
  • Monitor study progress, including participant recruitment, data collection, and regulatory compliance.
  • Develop and implement site-specific processes to optimize efficiency and quality in trial management.
  • Review and approve study-related documents, such as informed consent forms, case report forms, and monitoring reports.
  • Ensure accurate and timely data entry, query resolution, and reporting in clinical databases.
  • Manage site budgets, including the allocation of resources and financial oversight of study-related expenses.
  • Foster strong relationships with study participants, staff, and external stakeholders to ensure a positive and professional environment.
  • Address and resolve any issues or challenges that arise during the course of the clinical trials.


Qualifications:

  • Bachelor’s degree in a related field (e.g., life sciences, nursing, psychology).
  • Minimum of 2 years of experience in clinical research management, with a preference for experience in NASH, Obesity, Cancer, or CNS disorders.
  • In-depth knowledge of GCP, FDA regulations, and clinical trial processes.



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