Mirum Pharmaceuticals is looking to transform the treatment of rare diseases and needs a Senior CRA to lead sponsor oversight activities for clinical trials, ensuring high data quality, site compliance, and inspection readiness.
Requirements
- 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.
- Priority given to proven experience in CRO oversight and sponsor-level responsibilities.
- Good knowledge of ICH GCP and FDA/EMA regulations.
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.
- 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.
- 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.
Other
- Bachelor’s degree or equivalent in the life sciences or related field required.
- Additional coursework or certifications in clinical trial planning and operations desired.
- Experience in a Biotech company is an asset.
- 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.
