Nuvaira is seeking an experienced self-starter to join an expanding and dynamic start-up company in the Minneapolis area. The Clinical Trial Safety Specialist is responsible for general safety and compliance oversight of Nuvaira’s sponsored clinical studies. The Safety Specialist will oversee the safety program, including management of the Clinical Events Committee (CEC) and along with the study manager, the Data Monitoring Committee (DMC). This position will work closely with Regulatory Affairs by assisting in the submission of applicable safety notifications and required reporting globally. If a designated Medical Safety officer is assigned, this position will be responsible for ongoing education and for providing support as requested. This independent position requires strong attention to detail and proficiency in using spreadsheets, databases and the ability to perform basic statistical calculations and graph creation.
-Daily management of the safety program of all Nuvaira clinical trials. This includes tracking and assessment of all adverse events for reportability and for those that require adjudication as defined by the study protocol or associated documents.
-Perform coding of adverse events using the MedDRA dictionary. Interact with clinical and scientific staff to obtain confirmation of the coded terms.
-Perform coding of medications using the WHO drug dictionary. Interact with clinical and scientific staff to obtain confirmation of the coded terms.
– Ensure consistency and compliance in application definitions for adjudication outcomes across assigned studies
-Liaise with providers of MedDRA and WHO Drug to ensure proper version control and maintenance of valid license.
-Review of patient files and working with internal and external safety team members to interpret data
-Liaison for safety-related questions (e.g. to study team, monitors, study sites) and ensures AE and supporting source documentation are complete.
-Conduct safety data analysis and trending and assist in identifying appropriate corrective actions of events that may require escalation, including immediate communication to study and senior management.
-Periodic reporting of safety data to clinical and regulatory affairs.
-Referencing appropriate protocols and charters, manage active Clinical Events Committee (CEC) and/or Data Monitoring Committee (DMC), as requested. This includes coordinating CEC/DMC meetings and preparation of safety dossier packages, forms and procedures.
-Assist in training of study monitors and other study personnel with regards to safety and compliance procedures.
-Collaborate with Data Management and other departments on the review and development of study protocols, case report forms, study specific reports and other study forms related to safety.
-Ensure final accuracy of all clinical trials safety data and its timely availability, in an agreed format
-Manage translations of appropriate safety documentation as needed
-Work closely with Regulatory Affairs in the generation of Annual Progress reports as well as interim safety reports as required by the IRB or EC, etc. and other governing agencies.
-Demonstrate strong interpersonal skills and ability to independently confront issues for a positive outcome
-Contribute to the development and implementation of the safety program, process improvements and practices.
-May be asked to perform other Clinical responsibilities as needed
-LVN, RN or BS in Health Sciences, or higher equivalent education in relevant disciplines
-2+ years of clinical trial experience
-Excellent computer, organizational and multi-tasking skills
-Ability to effectively communicate across all levels of the organization
-Familiar with IDE, PMA, 510(k) or equivalent and GCP procedures
-International clinical trial experience
-Familiar with MedDRA and WHO Drug dictionary
-Familiar with EDC platform(s)
Physical Job Requirements:
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Upon request, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.
Nuvaira is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.