Basel

POSTION SUMMARY 

The Senior CRA at Mirum plays a crucial part by leading various aspects of Sponsor oversight activities related to monitoring of our clinical trials. The Senior CRA partners with the Clinical Project Manager, Clinical Trial Associate and Mirum Principal CRAs to provide overall support in matters related to investigational site management, site relationship building, site compliance, high data quality, inspection readiness and other study related activities, including study start-up, interim study monitoring as well as trial closeout activities..

KEY RESPONSIBILITIES 

• Plan and conduct clinical monitoring oversight visits.
• Ensure that CRO CRAs are trained appropriately to perform the monitoring visits and provide additional clinical monitoring training and support to the CRO personnel, as needed.
• Oversee that the CRO monitoring performance is conducted in accordance with the study plans and applicable SOPs.
• Build strong relationships with the Investigators and site staff when conducting site oversight visits.
• Review the CRO Monitoring Visit Reports within required timeframe and identify trends, oversee resolution of global and site-specific issues, track CRA compliance and escalate quality or non-compliance issues to study Principal CRA, CPM, CRA Manager, CRO Clinical Lead and CRO CPM.
• Oversee that Investigator Site Files are complete, accurate and inspection-ready.
• Participate in CRO CRA calls.
• Participate in the identification of potential Investigators and selection of sites.
• May participate in cross functional study team meetings; liaise with other functional areas to coordinate clinical monitoring activities.
• Identify clinical monitoring trends, oversee resolution of global and sites-specific issues following clinical monitoring oversight visits. Report monitoring oversight trends and issues to the study Principal CRA, CPM and CRA Manager.
• Prepare and contribute to study related documents such as clinical monitoring plan and oversight tools, recruitment tools, case report forms/eCRFs, informed consent forms, study plans and manuals, and site tools, as applicable.
• Support the TMF completeness efforts by performing routine spot-checks (i.e. during clinical monitoring oversight visit preparation, annual Mirum QC check, etc.) and communicate findings to the study Principal CRA, CTA, CPM, CRA Manager and the CRO.
• Support the study management team with audit and inspection activities related to site and monitoring.

QUALIFICATIONS

Education/Experience: 

• Bachelor’s degree or equivalent in the life sciences or related field required. Additional coursework or certifications in clinical trial planning and operations desired.
• Minimum 5 years of clinical monitoring experience, 3 years field monitoring.
• Experience in Site Selection, Initiation, Interim and Close-Out visits.
• Experience with monitoring in multiple countries.
• Experience in a Biotech company is an asset.
• Priority given to proven experience in CRO oversight and sponsor-level responsibilities.

Knowledge, Skills and Abilities:

• Good knowledge of ICH GCP and FDA/EMA regulations
• Good verbal and strong written communication skills.
• Highly organized and detail oriented.
• Ability to multi-task and work in a flexible and dynamic organization.
• Fluent in English, knowledge of any other European Language is an asset.
• Willing to travel up to 40% of the time.

#LI-Onsite