Clinical Trials Supervisor

1 week ago


New Bedford, Massachusetts, United States Genabio Diagnostics Full time

Position Overview

The Clinical Research Manager is responsible for overseeing and executing clinical monitoring and site management activities in alignment with ICH Good Clinical Practices, FDA regulations, ISO standards, local laws, and Genabio Diagnostics' standard operating procedures (SOPs). This role emphasizes the development and maintenance of strong collaborative relationships with investigational sites while closely coordinating with project management and regulatory teams to proactively identify and address risks related to patient safety and data integrity.

Key Responsibilities

  • Conduct site qualification, initiation, interim monitoring, and close-out visits.
  • Document findings from visits in monitoring reports for subsequent review and finalization.
  • Facilitate Institutional Review Board (IRB) submissions and renewals as necessary.
  • Collect and evaluate trial master documentation.
  • Encourage investigational sites to resolve queries and action items efficiently.
  • Maintain ongoing communication with research site personnel throughout the trial duration, addressing staffing changes and providing necessary training or retraining.
  • Contribute to the development of study plans, site trackers, reports, and participate in routine meetings.
  • Ensure adherence to study tools, training materials, and compliance with established processes, policies, and procedures.
  • Assist the Quality Assurance team with SOP revisions, audits, and inspections.
  • Perform additional tasks as assigned that are not explicitly described.

Qualifications

  • A Bachelor's degree or equivalent in life sciences, nursing, or a related field.
  • A minimum of 5 years of experience in clinical research, specifically with medical devices and in vitro diagnostic (IVD) products.
  • Alternatively, a combination of education, training, and experience in a life science environment with involvement in clinical trials.

Skills and Competencies

  • Commitment to continuous learning and training on ICH GCP, FDA, and ISO regulatory guidelines.
  • Exceptional written and verbal communication skills.
  • Strong time management abilities and meticulous attention to detail.
  • Capability to draft and revise SOPs, work instructions, forms, and templates.


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