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Clinical Research Associate Jobs
Company | Battelle |
Address | Columbus, OH, United States |
Employment type | FULL_TIME |
Salary | |
Category | Defense and Space Manufacturing,Aviation and Aerospace Component Manufacturing,Biotechnology Research |
Expires | 2023-06-17 |
Posted at | 1 year ago |
Battelle delivers when others can’t. We conduct research and development, manage national laboratories, design and manufacture products and deliver critical services for our clients—whether they are a multi-national corporation, a small start-up or a government agency.
- Plan, coordinate, and participate in site visits by research sponsors and regulatory agencies, as needed
- Support group QS conformance and lead project QS conformance
- Support risk management activities both on projects and within the QS
- Supervise research data collection, management, and reporting
- Collaborate with Principal Investigator to develop and implement protocols, plans, informed consent forms (ICF), etc.
- Lead continuous improvement efforts to reduce the cost of execution, cost of compliance, and cost of quality for the organization
- Execute basic statistical calculations
- Contribute to group regulatory compliance
- Plan and oversee daily administrative and research activities for investigational medical devices
- Identify situations where a statistician may be needed and assist in coordination of a statistician to execute statistical modeling, develop statistical rationale, and select appropriate statistical methods
- Support project regulatory compliance and project conformance to applicable standards
- Act as liaison between medical device design and manufacturing to assure transfer is smooth and responsibilities are managed and executed
- Assist or lead training and re-training of newly hired as well as current research staff
- Ensure compliance to federal, state, and local regulations and guidelines
- Develop and implement forms and documentation to meet requirements of new studies with investigational medical devices
- Lead test execution and conformance to requirements
- Interpret basic to moderate statistical calculations that have been performed by someone else
- Assist with activities to ensure compliance with Institutional Review Boards (IRB)
- Three years of experience in related industry (in a medical device capacity). One year of specific experience as a Clinical Research Associate or equivalent.
- Bachelor’s degree; five years of experience; or an equivalent combination of education and or experience in a related field; technical writing experience (writing sample may be required).
- U.S. Citizenship is required
- Five years of specific experience as a Clinical Research Associate or equivalent for investigational medical devices.
- Balance life through a compressed work schedule: Most of our team follows a flexible, compressed work schedule that allows for every other Friday off—giving you a dedicated day to accomplish things in your personal life without using vacation time.
- Flexible work arrangements: You have options for where you work and when you work.
- Prioritize wellness: Stay healthy with medical, dental, and vision coverage with wellness incentives and benefits plus a variety of optional supplemental benefits.
- Take time to recharge: You get paid time off to support work-life balance and keep motivated.
- Advance your education: Tuition assistance is available to pursue higher education.
- Build your financial future: Build financial stability with an industry-leading 401(k) retirement savings plan. For most employees, we put in 5 percent whether you contribute or not, and match your contributions on top of that.
- Better together: Coverage for partners, gender-affirming care and health support, and family formation support.
- Receive select funding to pursue ideas in scientific and technological discovery
- Nurture and develop the next generation of scientific leaders
- Collaborate with world-class experts in an inclusive environment
- Give back to and improve our communities
- Apply your talent to challenging and meaningful projects
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