Job Number: 413518
Senior Clinical Research Associate
Senior Clinical Research Associate (MN or Home-based)
- 3+ years of in-house Clinical Research Associate experience, and not just Monitoring experience.
- This position is necessary to help in the study startup of the Drug Coated Balloon (DCB) Global study.
- Duties will include Site Management, Vendor Management and Project Management responsibilities (under a Global Project Manager) for Latin America; specifically Colombia.
- The Senior CRA will work with the Clinical Research Specialist to satisfy applicable regulatory standards and company requirements for worldwide Clinical Studies.
- This position bridges the responsibilities of the Clinical Research Coordinator and the Clinical Research Specialist, and focuses on study management activities, oversight of CRO's, etc.
- Assists with successful conduct of assigned studies consistent with R&D and Marketing plans. This includes interfacing with representatives from key functional groups including Field Clinical Operations, Product Development, Manufacturing, Sales, Marketing, Distribution, Regulatory Affairs, and European Clinical Groups.
- Assists in preparation of study materials and training of investigators, center staff and ev3 field staff.
- Writes the monitoring plan
Qualifications & Skills
- Coordinates and conducts monitoring at participating centers to ensure compliance with the protocol and regulations and the timely receipt of accurate data and other required study documents.
- Reviews clinical data/information and oversees data correction. Assists clinical research specialists in providing interim and final reports and presentations.
- Provides input to study budgets and project plans.
- Assists clinical research specialists by providing sections of Investigational Plan or protocol as needed.
- Assists Clinical Research Specialist in writing sections of the PMA Clinical Reports.
- Takes initiative to oversee activities of Contract Research Organizations (CRO's).
- Reviews and verifies adequacy of center activation documentation.
- Position may require up to 35% travel. May include trips within the US, Europe, or Latin America
Does not have to be a local candidate to MN Office. Can work remotely from another state
Four year degree required
3-5 years of experience as an in-house Clinical Research Associate required (NOT JUST MONITORING)
Project Management skills required
Medical Device experience required (Combination product experience a plus)
CRO management experience required
Latin America experience required (Colombia specifically a plus)
Spanish speaking a plus
Ability to travel up to 35% - may include trips within the US, Europe, or Latin America
High attention to detail and accuracy.
Advanced written and oral communications skills.
Able to manage multiple tasks.
Proficient knowledge of medical terminology.
Expertise with GCPs and regulatory compliance guidelines for clinical trials.
Good problem-solving skills.
Knowledge of clinical and outcomes research study design.