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The Clinical Research Associate I will be responsible for executing the current and planned post-market orthopedic clinical studies. The CRA also co-monitors investigator sites in compliance with company SOPs, ICH / GCP and local laws so that site performance targets are achieved.
Essential Duties and Responsibilities:
• Support and mentor the Clinical Trial Associate (CTA) in maintaining the Trial Master Files
• Perform all CTA responsibilities alongside the CTA
• Understand the objectives, responsibilities, and mission of the Clinical Affairs department and works towards those goals
• Develop CRA I skills by co-monitoring with senior level CRAs
- Travel to sites to observe site qualification, initiation and closeout visits
- Travel to sites to observe and conduct interim monitoring visits
- Work with CRA on remote monitoring
- Observe interactions of senior level CRA and the sites in regards to communication and interactions with IRBs and Ethics committees
- Learn to identify issues that may impact on the conduct of the study and ensure appropriate closure of all issues
• Manage 1-3 sites independently, but closely supervised
- Serve as a site contact responsible for site support, IRB submission & approval support, collection of regulatory documents, etc.
- Serve as site contact liaison to ensure enrollment goals are met and answer any study related questions
- Ensure studies are run in line with ICH/GCP, local laws, and company SOPs and procedures
- Ensure patient safety is maintained and all safety issues are reported correctly according to all relevant local and federal regulatory requirements
- Prepare clinical study reports and other regulatory documents with oversight from senior level CRAs
- Prepare and develop corrective and preventative actions with PI and site personnel to close all open issues.
• Prioritize and plan work activities with supervision
• Prepare reports, slides, and presentations of status of clinical studies as requested.
• Other responsibilities as assigned.
• Bachelor's degree or higher in Life Sciences or Nursing
• 1-3 years of clinical research experience to include clinical study monitoring
• Works both individually and as a member of the team to monitor sites
• Demonstrate knowledge of clinical trial methodology and the device development process as related to monitoring clinical trials, GCP, FDA regulatory environment
• Knowledge of GCP and ICH Guidelines for clinical studies
• Medical device experience preferred
Skills, Abilities, Competencies Required:
• Excellent written and verbal communication skills
• Strong attention to detail
• Ability to work accurately in a fast-paced, ever-changing environment with strong attention to detail
• Ability to adapt to change in a positive manner
• Demonstrate problem solving skills
• Ability to build effective relationships with clinical sites and support staff
• Demonstrate ability to monitor own work to ensure quality, accuracy and thoroughness
• Ability to communicate effectively and appropriately with internal and external stakeholders
• Strong organizational, analytical and time-management skills
• Ability to self-motivate and work both independently and as part of a team
• Ability to travel up to 50% domestically as needed
• Strong computer skills (Microsoft Office Suite)
• Maintain knowledge and expertise on all relevant SOPs
• Standing or sitting for extended periods
• Ability to bend at the knees
• Lifting up to 20 pounds
• Busy work environment with frequent interruptions
• Must be aware of hazards within the company:
- Adhere to quality and safety standards established by FDA and other regulatory agencies
• Able to work in changing environments:
- Reduced lighting, increased noise, temperature variances, unpleasant odors, etc.
Conformis is an Equal Opportunity Employer
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