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岗位信息
POSITION DESCRIPTION:
The Associate Clinical Research Monitor is responsible for the oversight of clinical research conducted at investigational sites to ensure compliance with study protocols, applicable regulatory standards, IRB/EC policies and procedures and business policies. This position works under supervision as needed, working closely with study teams, site personnel, Medtronic field personnel and monitoring supervisor for resolution of site issues.
POSITION RESPONSIBILITIES:
- Perform site monitoring visits in accordance with the study Monitoring Plan to ensure compliance with the Investigational Plan, Monitoring Plan, applicable regulatory, IRB/EC, and Medtronic standards, guidelines and policies.
- Communicate visit findings with site personnel and complete a written letter for distribution to the Principal Investigator and appropriate site personnel for follow-up.
- Prepare site visit reports and correspondence for all visits conducted in accordance with the study Monitoring Plan.
- Identify site needs, provide solutions to facilitate the clinical trial process.
- Act as a primary point of contact for study sites as requested.
- Assist in initial and ongoing site personnel training as required.
- Identification and escalation of protocol deviations, discrepancies in data, and non-compliance to study protocols, applicable regulations, Good Clinical Practices and Standard Operating Procedures.
- Collaborates with monitoring management and study team personnel towards securing Investigator compliance.
- Understand the study protocol and accompanying background information (e.g., Investigator Brochure, Report of Prior Investigations etc.)
- Possess a working knowledge of disease state and investigational product.
- Possess understanding of regulatory requirements.
- Attend internal department and team meeting as requested.
- Adhere to all applicable Medtronic policies and procedures.
- In addition, the Associate Clinical Research Monitor may:
- Attend Investigator and/or Coordinator meetings.
- Provide input into final study site selection.
- Be involved in site management activities.
延展资料
