The Principal Clinical Research Associate will support in-house clinical research activities and remote/onsite monitoring of assigned sites that are actively participating in Nuvaira clinical trials. Under the direction of the Director of Clinical, the Principal Clinical Research Associate (CRA) will be responsible for oversight of all global study monitoring activities in addition to conducting remote/onsite monitoring visits and site management of assigned sites. The Principal CRA may also assist with data review, vendor management and creation/maintenance of study plans as needed.
- Oversee global monitoring activities and compliance with study monitoring plan (g., timeline adherence, quality of data review, resolution of findings/action items);
- Manage vendors hired to assist with monitoring activities, as applicable;
- Create/maintain study plan(s) directly related to monitoring and provide input into study plan(s) indirectly associated with monitoring;
- Support study initiation, monitoring, audit and close out phases of assigned clinical trials as prescribed in the sponsor SOPs and study monitoring plan;
- Act as the primary point of contact with assigned clinical study sites;
- Ensure clinical study site documentation compliance according to GCPs, ICH and FDA regulations;
- Facilitate timely and accurate communication flow between the clinical study sites, sponsor and applicable vendors;
- Collaborate with clinical study site to trouble shoot and provide appropriate solutions to study-related issues, as appropriate;
- Assist in patient recruitment activities;
- Assist in local education and training/retraining;
- Assist with the development/continuous improvement of study-related documents as requested;
- Prepare accurate and timely study reports as requested;
- Work independently and under general supervision.
- Bachelor’s degree (or higher) in nursing, health sciences or related field;
- Minimum of 5 years onsite/remote monitoring experience with IDE medical device studies;
- In-house CRA experience with IDE medical device studies preferred (g., familiarity with standard study plans, clinical trial operations);
- Experience providing project performance management to project team members preferred;
- Strong oral and written communication skills;
- Good understanding of FDA regulations related to clinical trials; GCPs and ICH Guidance;
- Proven organizational skills and the ability to manage multiple priorities;
- Strong computer skills;
- Local candidate preferred, however open to candidates located outside Mpls/St. Paul area;
- Ability to travel up to 80% during peak periods.
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.