Thank you for your interest in joining the team here at Vesper Medical. We share a passion and commitment to advancing the treatment of deep venous disease – if you think you’d be a good fit for our team, please feel free to apply to one of the positions below.
Clinical Research Associate (CRA)
The CSM supports clinical research sites with patient enrollment in compliance with applicable regulatory standards, IRB/EC policies and procedures and Vesper Medical’s internal requirements. This position works with minimal supervision and directly with study management and the study team.
- Responsible for coordinating field activities with clinical site needs to ensure clinical protocol is followed, device is used according to Instructions for Use, and enrollment goals are met.
- Provide training to Investigators, Site Staff, and assigned Vesper Medical staff.
- Assist in follow-up and resolution of site issues, as applicable.
- Assist in device allocation, reconciliation, accountability and retrieval.
- Assist with reporting, compliance, review, and conclusion of device events/complaints.
- Responsible for site follow up regarding imaging feedback from Core Labs.
- Able to refer to Standard Operating Procedures (SOPs) for guidance on everyday study tasks.
- Participate in training to enhance knowledge base.
The successful candidate must have / be:
- Strong verbal and written communication skills, technical and problem-solving skills.
- Able to read, analyze and interpret general business documents, technical procedures, and standard operating procedures.
- Able to work effectively, independently and on cross-functional teams.
- Able to write reports, business correspondence and procedure manuals effectively.
- Able to frequently use general knowledge of industry regulations, practices, techniques, and standards.
- Develop solutions to a variety of problems of moderate scope and complexity.
- Able to refer to policies and regulations for guidance.
The above statements are intended to describe the general level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities.
Education and Experience:
- Education Level: Bachelor’s Degree and 1+ year of experience in clinical / clinical research setting.
- Knowledge of ICH and GCP Guidelines
- Strong computer literacy with Microsoft Office
- Must have a valid driver’s license
- Flexible and able to work with deadlines
- Team player who can also operate alone
- Solution-oriented and problem-solving attitude
- Good project management and organizational skills. Ability to prioritize work.
- Excellent verbal and written skills, good organizational, interpersonal, and team skills.
- Hands-on team player with the ability to work in a fast paced, dynamic start-up environment.
- Experience working with small cross-function product/process development teams.
- Knowledge and experience appropriate to perform risk management tasks. These shall include, where appropriate, knowledge and experience of the particular medical device (or similar medical devices) and its use, the technologies involved or risk management techniques.
Environment and Physical Functionality:
- General office, laboratory and medical device research and manufacturing environment
- Includes varying work schedule
- Prolonged periods of sitting, standing and walking
- Travel by automobile, train and aircraft (approximately 80% of the time), both domestic and international travel and occasional travel on weekends
Please send your resume and cover letter to email@example.com.