Clinical Monitoring Oversight Assessor - Contractor

The Clinical Monitoring Oversight Assessor is an independent consulting (IC) role that will perform clinical quality oversight duties assigned by Beaufort for one or more clinical trial sites. Specific tasks will be assigned to the IC by the Project Manager (as applicable to the scope of the project), who will also be responsible for management oversight for the individual throughout the engagement. Beaufort is seeking qualified ICs that reside in Europe to work at various sites in Europe. For each site to which the individual is assigned, responsibilities will include some or all of the following tasks:

• Participate in project specific training program developed by Beaufort or by client, including review key study documents (e.g. Protocol, Monitoring Plan, Communication Plan, etc.), participate in training sessions to review project specific requirements.
• Observe and assess individual CRA’s level of knowledge, experience, training, and behaviors while conducting routine on site monitoring visits. The visits are intended to observe, assess, and document behaviors and work practices of the CRAs, in both positive aspects as well as in areas of needed improvement, within the context of the applicable sponsor/CRO contract terms and expectations, study requirements, work instructions, GCP guidelines, and the immediate, on-the-ground circumstances present during the site visit.
• Observe and assess individual site level of knowledge, experience, training, and behaviors while conducting routine on site monitoring visits. The visits are intended to observe, assess, and document behaviors and work practices of the site personnel, including but not limited to the Principal Investigator and Study Coordinator, within the context of the applicable study requirements, GCP guidelines, and regulatory requirements.
• During site visits, identify issues that require corrective actions, follow up with the CRA (when circumstances warrant) and Beaufort Project Manager to ensure issues of concern are recognized and escalated for response by the CRO and/or sponsor, and provide advice and guidance on appropriate options for response when requested.
• Perform other project-related tasks assigned to the Quality Oversight Assessor role as specified in the individual’s Statement of Work.

Required Education/Professional Experience:

• Bachelor’s degree (biological science, pharmacy or other health related discipline preferred) or relevant clinical or business equivalent.
• At least 3-5 years of clinical research field monitoring experience.
• Must have experience with any of the following: Co-monitoring, Quality Assurance, Project Management, CRA Oversight or Training, Mentoring, and Leading other CRAs.
• Flexibility to travel to perform site visits within the country of origin and outside.

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