Clinical Trial Safety Specialist

Position Summary:

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.

 

Responsibilities:

-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

 

Qualifications:

-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

 

Preferred Qualifications:

-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.

Clinical Research Associate – Europe (Consultant)

Position Summary:

The Clinical Research Associate (Europe) will support regional conduction of clinical research within participating research centers for our global clinical trials.  The Clinical Research Associate (CRA) will act as the site manager for assigned sites and is responsible for developing positive relationships by providing clinical protocol training and support, monitoring, clinical investigation awareness, recruitment assistance and continuing education for our emerging medical device.  The CRA will also be responsible for communicating internally any market dynamics, study issues or potential improvements, study activities/compliance, adverse event information and study enrollment strategies.  The CRA will work with other members of the international study team(s) and assist with clinical vendor management and study long-term follow-up logistics as appropriate.

 

Responsibilities:

  • Support the start-up, monitoring, audit and close out phases of assigned clinical trials
  • Develop a strong understanding of internal Standard Operating Procedures
  • Ensure compliance of ICH/GCP, medical devices standards and local regulations at assigned clinical sites
  • Independently identify and follow-up on adverse events and other safety issues;
  • Assist in local education and training/retraining
  • Assist in patient recruitment activities
  • Collaborate closely with Clinical Project Manager(s) to track centers and patients’ status
  • Facilitate timely and accurate communication flow between the sites, company and applicable vendors
  • Work closely with clinical product training and proctoring team
  • Partner with other company personnel as necessary to achieve established study and company goals
  • Assist with study documentation creation and dissemination as requested
  • Train junior clinical personnel as appropriate to study protocols, department procedures, regulations, etc. as requested

 

Qualifications:

  • Undergraduate degree in a related health field is essential with 2+ years of direct experience
  • Familiar with GCPs, ICH guidelines and FDA regulations
  • Prior monitoring experience
  • Proven organization skills and the ability to manage multiple priorities
  • Ability to manage personal expenses
  • Excellent communication, both oral and written, and presentation skills
  • Strong computer knowledge (Microsoft Office)
  • Strong interpersonal skills
  • Ability to effectively solve problems
  • Ability to work independently (field-based position)
  • Ability to travel up to 80% (limited Non-EU travel may be required)

 

Preferred Qualifications:

  • German, French and English speaking/writing
  • Familiarity with pulmonary clinical research preferred

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.

 

Clinical Research Associate Manager

Position Summary:

The Clinical Research Associate Manager (US) will support conduct of clinical research within assigned clinical research centers that are actively participating in Nuvaira clinical trials and manage a small team of regional CRAs. As the Clinical Research Associate (CRA), you will act as the site manager for assigned clinical centers and will be responsible for developing positive relationships by providing clinical protocol training and support, study monitoring, clinical investigation awareness, recruitment assistance and continuing education for our emerging medical device. The CRA Manager will also be responsible for communicating internally any market dynamics, study issues or potential improvements, study activities/compliance, adverse event information and study enrollment strategies.  As the CRA Manager, you will be responsible for daily management and task assignment of two-three regional CRAs. The CRA Manager will work closely with the study manager(s) to assist in overall trial conduction as appropriate.

 

Responsibilities:

  • Act as the primary point of contact with assigned clinical study sites;
  • Manage a small team of regional based CRAs
  • Ensure sufficient site and procedure coverage by CRAs and guide CRAs with site issues
  • Support study initiation, monitoring, audit and close out phases of assigned clinical trials as prescribed in the sponsor SOPs and study monitoring plan;
  • Ensure clinical study site compliance according to GCPs, ICH and FDA regulations;
  • Schedule, conduct and document Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits;
  • Provide and document initial and ongoing study training (eg. protocol, EDC, etc.) to study site personnel;
  • Ensure the protection of study subjects by verifying that the informed consent procedure and study protocol testing and procedures are performed appropriately and in alignment with the study protocol;
  • Ensure the integrity of the clinical data submitted on eCRFs or other data collection tools by verifying against source documentation at the clinical study site;
  • Ensure appropriate record-keeping at the clinical site, as well as the collection and submission of essential study documents to the study sponsor;
  • Ensure appropriate investigational device storage and tracking at the clinical site;
  • Independently identify and follow up on adverse events and other safety issues related to the clinical study, and ensure timely communication of serious adverse events to the Clinical Study Manager;
  • Provide relevant, timely study subject updates to the Clinical Study Manager (eg. upcoming treatment dates, subject withdrawals, etc.);
  • Facilitate timely and accurate communication flow between the clinical study sites, sponsor and applicable vendors;
  • Collaborate with clinical study site and sponsor to trouble shoot and provide appropriate solutions to study-related issues, as appropriate;
  • Work closely with clinical product training and proctoring teams;
  • Assist in patient recruitment activities;
  • Assist clinical study sites with audit preparedness;
  • Assist with the development of study-related documents as requested;
  • Prepare accurate and timely study visit reports as required by the study monitoring plan;
  • Manage travel and expenses;
  • Work independently and under general supervision.

 

Qualifications:

  • Bachelor’s degree (or higher) in nursing, health sciences or related field
  • Minimum of three years of CRA experience with at least two years of clinical site monitoring;
  • Good understanding of FDA regulations related to clinical trials; GCPs and ICH Guidance;
  • Respiratory disease trial experience preferred;
  • Medical device trial experience preferred;
  • Personnel management experience preferred;
  • Strong oral and written communication skills;
  • Proven organizational skills and the ability to manage multiple priorities
  • Ability to travel approximately 50% with extensive travel during peak periods (up to 75%)
  • Ability to manage personal expenses
  • Strong computer skills

 

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.

 

Clinical Research Associate

Position Summary:

The Clinical Research Associate (US) will support regional conduct of clinical research within clinical research centers that are actively participating in Nuvaira clinical trials. The Clinical Research Associate (CRA) will act as the site manager for assigned clinical centers and will be responsible for developing positive relationships by providing clinical protocol training and support, study monitoring, clinical investigation awareness, recruitment assistance and continuing education for our emerging medical device. The CRA will also be responsible for communicating internally any market dynamics, study issues or potential improvements, study activities/compliance, adverse event information and study enrollment strategies. The CRA will work with members of the clinical study team(s) and assist with clinical vendor management and study long-term follow-up logistics as appropriate.

We have two CRA positions available, one targeted in the southeast region and one in the northeast region.

Responsibilities:

  • Act as the primary point of contact with assigned clinical study sites;
  • Support study initiation, monitoring, audit and close out phases of assigned clinical trials as prescribed in the sponsor SOPs and study monitoring plan;
  • Ensure clinical study site compliance according to GCPs, ICH and FDA regulations;
  • Schedule, conduct and document Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits;
  • Provide and document initial and ongoing study training (eg. protocol, EDC, etc.) to study site personnel;
  • Ensure the protection of study subjects by verifying that the informed consent procedure and study protocol testing and procedures are performed appropriately and in alignment with the study protocol;
  • Ensure the integrity of the clinical data submitted on eCRFs or other data collection tools by verifying against source documentation at the clinical study site;
  • Ensure appropriate record-keeping at the clinical site, as well as the collection and submission of essential study documents to the study sponsor;
  • Ensure appropriate investigational device storage and tracking at the clinical site;
  • Independently identify and follow up on adverse events and other safety issues related to the clinical study, and ensure timely communication of serious adverse events to the Clinical Study Manager;
  • Provide relevant, timely study subject updates to the Clinical Study Manager (eg. upcoming treatment dates, subject withdrawals, etc.);
  • Facilitate timely and accurate communication flow between the clinical study sites, sponsor and applicable vendors;
  • Collaborate with clinical study site and sponsor to trouble shoot and provide appropriate solutions to study-related issues, as appropriate;
  • Work closely with clinical product training and proctoring teams;
  • Assist in patient recruitment activities;
  • Assist clinical study sites with audit preparedness;
  • Assist with the development of study-related documents as requested;
  • Prepare accurate and timely study visit reports as required by the study monitoring plan;
  • Manage travel and expenses;
  • Work independently and under general supervision.

Qualifications:

  • Bachelor’s degree (or higher) in nursing, health sciences or related field
  • Minimum of two years of CRA experience with at least one year of clinical site monitoring
  • Good understanding of FDA regulations related to clinical trials; GCPs and ICH Guidance
  • Respiratory disease trial experience preferred
  • Medical device trial experience preferred
  • Strong oral and written communication skills
  • Proven organizational skills and the ability to manage multiple priorities
  • Ability to travel approximately 50% with extensive travel during peak periods (up to 75%)
  • Ability to manage personal expenses
  • Strong computer skills

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.