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.
- 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
- 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)
- 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.