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 safety compliance oversight of Nuvaira’s sponsored clinical studies. The Safety Specialist will oversee the safety program, including development of applicable safety process documents, 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, including providing ongoing education and support for aggregate safety surveillance and individual event assessment as needed. 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 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.
- Ensure consistency and compliance in application definitions for event adjudication outcomes
- Review patient files and source documentation while working with internal and external safety team members to interpret data and compile complete adverse event summaries/narratives.
- Review AEs as entered into the EDC system and perform queries within the system as required for event clarification or additional information
- Act as the primary point of contact for initial safety-related questions (e.g. to study team, monitors, study sites) and ability to triage safety concerns as appropriate.
- Ensures AE and supporting source documentation are complete.
- Conduct aggregate safety data analysis and trending against current thresholds for prospectively defined events of special interest and assist in escalation, including immediate communication to Medical Safety Officer and study/ senior management.
- Present periodic safety updates and reporting of safety data to internal Nuvaira teams
- Manage active Clinical Events Committee (CEC) including coordinating CEC meetings, preparation of safety dossier packages, forms and AE summaries, and aggregate safety line listings, as required. Also includes committee member selection, and member maintenance (e.g. contractual agreements, monthly invoicing, etc).
- Assists in training of study monitors and other study personnel with regards to safety and compliance procedures.
- Collaborates with Data Management and other departments on the review and development of study protocols, AE case report forms, study specific reports and other study documents related to safety.
- Ensure final accuracy of all clinical trial safety data and ensure its timely adjudication and availability
- Manage translations of appropriate safety documentation as needed, by working closely with study vendors
- Work closely with Regulatory Affairs in the generation of the safety section in clinical reports, including: Annual Progress reports as well as interim safety reports as required by the IRB or EC, etc. and other governing agencies.
- Collaborate cross-functionally with other scientific teams for input on safety related projects, as applicable.
- 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
- Knowledge of adverse event reporting regulations such as 21CFR812, MEDDEV 2.7/3 and ISO14155:2011
- 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.