Current Openings

Principal Clinical Safety Specialist

Position Summary:

Nuvaira is seeking an experienced self-starter to join an expanding and dynamic pre-commercial company in the Minneapolis area.  The Principal Clinical Safety Specialist is responsible for general safety and safety compliance oversight of Nuvaira’s sponsored clinical studies.  The Principle Clinical Safety Specialist will oversee the safety program, including development of applicable safety process and plans, along with management of the Clinical Events Committee (CEC). This position will work closely with Regulatory Affairs by assisting in the submission of applicable safety notifications and required reporting globally.  This position will also work closely with the Medical Safety officer and CEC committee for safety surveillance and adverse event assessment.

 

Responsibilities:

  • Oversight of the safety program of all Nuvaira clinical trials. This includes tracking and assessment of adverse events for reportability and for those that require adjudication.
  • Author study specific safety documents and plans (eg: CEC Charter, Adverse event adjudication plan, etc.).
  • Manage and provide guidance to the Clinical Events Committee (CEC); inclusive, but not limited to, coordinating CEC meetings, preparation of safety dossier packages, and oversight of the adverse event adjudication process.
  • Collaborate with sites/CRA to ensure comprehensive information is available for full review of adverse events.
  • Conduct aggregate safety assessment and trending against current thresholds for events of special interest and assist in escalation, including communication to Medical Safety Officer and study/ senior management.
  • Provide safety-related input to study documents/processes as requested (eg: CIP, CRF design, annual reports, study reports etc.).
  • Manage adverse event processing including report review, safety query management and expedited reporting.
  • Ensure consistency and compliance in application definitions for event adjudication outcomes.
  • Coordinate, participate in the preparation for, and attend (as applicable), CEC and DMC meetings.
  • Ensure consistency and compliance in application of protocol definitions for adjudication outcomes.
  • Participate in preparation of weekly regulatory submissions of events meeting expedited reporting criteria according to specific country regulations.
  • Perform coding of adverse events and medical history using the MedDRA dictionary, and adherence to study coding convention documents.
  • Manage translations of appropriate safety documentation as needed, by working with study vendors.
  • Contribute to the development and implementation of the safety program, process improvements and practices.
  • May be asked to perform other Clinical responsibilities, as needed.

 

Qualifications:

  • LVN, RN or BS in Health Sciences, or higher equivalent education in relevant disciplines
  • 6+ years of clinical safety and study 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
  • Knowledge of adverse event reporting regulations such as 21CFR812, MEDDEV 2.7/3 and ISO14155:2011

 

Preferred Qualifications:

  • International clinical trial experience
  • Familiar with MedDRA (MedDRA certification strongly preferred or be obtained upon hire)
  • 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.

Apply by sending your resume to [email protected]