Henderson Clinical Trials-posted about 1 year ago
$72,800 - $72,800/Yr
Full-time • Mid Level
Henderson, NV

The Clinical Research Assistant Manager plays a crucial role in overseeing and coordinating clinical research activities. This position involves managing the planning, execution, and completion of clinical research studies while ensuring compliance with regulatory standards and supporting clinical trial operations. The role requires collaboration with Principal Investigators, Clinical Research Coordinators, and other team members to facilitate efficient research processes.

  • Assist in the design, implementation, and monitoring of clinical research protocols.
  • Ensure that clinical studies are conducted according to the study protocol, Good Clinical Practice (GCP), and regulatory requirements.
  • Manage day-to-day activities of clinical research staff to ensure timely and accurate data collection.
  • Assist with participant recruitment, enrollment, and retention efforts.
  • Monitor and ensure that all required documentation is maintained, such as informed consent forms, ethics committee approvals, and regulatory submissions.
  • Ensure compliance with regulatory bodies (FDA, EMA, ICH-GCP, etc.) and organizational policies.
  • Oversee the collection, management, and storage of study data.
  • Ensure the accuracy, integrity, and confidentiality of clinical trial data.
  • Prepare reports and documentation for progress updates, data analysis, and regulatory submissions.
  • Supervise and mentor clinical research assistants and other team members.
  • Provide training and guidance to staff on clinical research protocols and best practices.
  • Collaborate with the Principal Investigator and Clinical Research Coordinator to allocate resources effectively.
  • Assist in budgeting and resource planning for clinical trials.
  • Track and report on study expenses, ensuring that the budget is adhered to.
  • Assist in conducting internal audits and inspections to ensure adherence to protocols and regulations.
  • Identify and address issues related to protocol deviations or non-compliance.
  • Serve as a liaison between clinical research staff, principal investigators, sponsors, and other stakeholders.
  • Prepare and present findings or updates during team meetings.
  • Bachelor's degree in life sciences, healthcare, or related field (Master's preferred).
  • 2+ years of experience in clinical research, with at least 1 year in a managerial or supervisory role.
  • Strong understanding of clinical research methodologies, GCP, and regulatory requirements.
  • Familiarity with clinical trial management software and data management systems.
  • Excellent organizational and time-management skills.
  • Strong interpersonal and communication skills.
  • Ability to work well under pressure and manage multiple tasks simultaneously.
  • Experience with clinical trials (1 year preferred).
  • Experience in research (1 year preferred).
  • Ability to commute to Henderson, NV 89052 (preferred).
  • Willingness to relocate to Henderson, NV 89052 before starting work (preferred).
  • Dental insurance
  • Flexible schedule
  • Health insurance
  • Paid time off
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