(Sr) CRA (Sweden)
Office-based or home-based
As (Sr) CRA your main duties will include, but will not be limited to:
- Ensure for Country trial start up activities, i.e. Translation of study documents, HA submission and Clinical supplies check-up/import at project level.
- Ensure to set up proper recruitment/maintenance plan based on appropriate analysis of capability of sites selected.
- Support the site initiation and training executed by CRAs.
- Ensure Country Specific master file and facilitate preparation and monitor the collection of site Level documents by CRAs; resolve problems as required.
- Ensure Planning and Set up the local trial timeline with CRA for the key metrics i.e. IRB submission, site contract, site initiation, patient recruitment, routine monitoring, close out activities.
- Monitor on status of planned versus actual patient recruitment/timeline and implement strategies to correct deviations from proposed plan according to metrics.
- Ensure the site level compliance/adequate site management through co-monitoring visit with the CRA if necessary.
- Liaise with global TA/BU clinical teams and CPOs to identify issues and mediate resolution in a timely manner at a project level.
- Review study monitoring reports which monitor generated, as assigned.
- Identify project and Clinical Operations issues that will impact the successful conduct of a trial and bring to the attention of the GMO Head for information and/or resolution in a timely manner.
- Supervise the monitor of the implementation of site closeout activities.
- Act as local and/or global CRA lead and author global monitoring plan, as assigned.
- Act as a mentor to new associates for purposes of field training, as assigned.
- Work to coordinate for audits if necessary.
- Participate in multi-disciplinary teams within CPO and globally to evaluate and implement process improvement.
The ideal candidate will need the following experience / skills to be considered:
- Education: A degree in scientific or health discipline required and advanced degree is preferable
- Fluent English (both written and spoken)
- Understand and apply medical and business know-ledge to clinical trial execution.
- About 2 years’ experience in clinical research or having demonstrated adequate level of proficiency within the CRA II competency profile.
- Oncology experience will be asset.
- Solid understanding of clinical trial design, trial ex-ecution and operations.
- Knowledge of international standards (GCP/ICH), international (FDA, EMEA) and local regulations.
- Expertise in communication, managing multiple priorities and computer literacy.
- Proven people management skills with demonstrated expertise in working on teams.