Clinical Research Associate
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 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
- 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)
- Familiarity with pulmonary clinical research preferred
- German or French and English speaking required
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.
While applying for the job please refer to jobvector and use the following reference number: 104CRA
About Holaira, Inc.
Holaira, Inc. (formerly Innovative Pulmonary Solutions, Inc.) located in Minneapolis, Minnesota is a privately held lung denervation company developing minimally invasive products to make breathing easier for patients suffering from obstructive lung diseases. Founded in 2008, Holaira is currently working on a novel catheter-based system that has the potential to improve lung function,...More about Holaira, Inc.