Clinical Trials Operations Manager

1 week ago


DuBois, Pennsylvania, United States Lung Innovations Network Full time
Position Overview

The Clinical Research Coordinator plays a pivotal role in overseeing the execution of clinical trials within the Lung Innovations Network. This position is responsible for the comprehensive management of trial activities from inception to conclusion, ensuring adherence to regulatory standards and protocols.

Key Responsibilities
  1. Trial Management: Strategically plans and coordinates all activities related to clinical trials, ensuring compliance with regulatory bodies and safeguarding participant welfare.
  2. Patient Interaction: Engages with clinical staff to identify and recruit eligible patients for participation in studies, providing them and their families with essential information regarding the investigational process.
  3. Education and Training: Conducts training sessions for clinic personnel involved in the research, ensuring they are well-informed about the study protocols.
  4. Data Management: Collects, organizes, and maintains all relevant clinical data, case report forms, and regulatory documentation in accordance with sponsor requirements.
  5. Monitoring and Follow-Up: Performs ongoing patient monitoring and follow-up as dictated by study protocols, ensuring data integrity and participant safety.
  6. Protocol Compliance: Assists investigators in daily research activities, confirming informed consent and maintaining accurate subject files.
  7. Administrative Duties: Handles various administrative tasks related to clinical research, including participant screening and data entry into designated databases.
  8. Preparation for Audits: Prepares for monitoring visits and ensures that all documentation is accurate and readily available.
Qualifications

Experience: A minimum of 5 years in a related field is required, with a preference for experience in Pulmonology.

Essential Skills:

  • Exceptional time management and organizational abilities.
  • Meticulous attention to detail and strong problem-solving capabilities.
  • Outstanding written and verbal communication skills.
  • Ability to work independently with a proactive approach.

Preferred Skills: Proficiency in Microsoft Office applications.

Employment Type

This is a full-time position offering a comprehensive benefits package, including health insurance, dental coverage, retirement plans, and paid time off.

Work Environment

Please note that this position requires travel and is not eligible for remote work.



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