Job details

Clinical Research Associate

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.

We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply.

Job Summary

Battelle is seeking a Clinical Research Associate (CRA) to support our Medical Device Solutions team; in Columbus, OH. The CRA will participate in the design, organization, and performance of daily research project activities related to investigational medical devices. Responsibilities include supporting team execution and accountability for project compliance to Quality Systems (QS) and applicable standards/regulations through collaboration, review, and approval of key project documents. The CRA will monitor overall project conformance to QS standards and regulations, support planning for conformance, and assist and lead resolution of exceptions. The CRA will develop, analyze, and report key performance metrics and support management of key quality subsystems.

Responsibilities

Collaborate with Principal Investigator to develop and implement protocols, plans, informed consent forms (ICF), etc.
Develop and implement forms and documentation to meet requirements of new studies with investigational medical devices
Plan and oversee daily administrative and research activities for investigational medical devices
Assist or lead training and re-training of newly hired as well as current research staff
Supervise research data collection, management, and reporting
Assist with activities to ensure compliance with Institutional Review Boards (IRB)
Ensure compliance to federal, state, and local regulations and guidelines
Plan, coordinate, and participate in site visits by research sponsors and regulatory agencies, as needed
Support group QS conformance and lead project QS conformance
Contribute to group regulatory compliance
Support project regulatory compliance and project conformance to applicable standards
Support risk management activities both on projects and within the QS
Lead test execution and conformance to requirements
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
Interpret basic to moderate statistical calculations that have been performed by someone else
Execute basic statistical calculations
Act as liaison between medical device design and manufacturing to assure transfer is smooth and responsibilities are managed and executed
Lead continuous improvement efforts to reduce the cost of execution, cost of compliance, and cost of quality for the organization

Key Qualifications

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).
Three years of experience in related industry (in a medical device capacity). One year of specific experience as a Clinical Research Associate or equivalent.
U.S. Citizenship is required

Preferred Qualifications

Five years of specific experience as a Clinical Research Associate or equivalent for investigational medical devices.

Benefits: Live an Extraordinary Life
We care about your well-being, not just on the job. Battelle offers comprehensive and competitive benefits to help you live your best life.

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.
Take time to recharge: You get paid time off to support work-life balance and keep motivated.
Prioritize wellness: Stay healthy with medical, dental, and vision coverage with wellness incentives and benefits plus a variety of optional supplemental benefits.
Better together: Coverage for partners, gender-affirming care and health support, and family formation support.
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.
Advance your education: Tuition assistance is available to pursue higher education.
Flexible work arrangements: You have options for where you work and when you work.

A Work Environment Where You Succeed
For brilliant minds in science, technology, engineering and business operations, Battelle is the place to do the greatest good by solving humanity’s most pressing challenges and creating a safer, healthier and more secure world.

You will have the opportunity to thrive in a culture that inspires you to:

Apply your talent to challenging and meaningful projects
Receive select funding to pursue ideas in scientific and technological discovery
Collaborate with world-class experts in an inclusive environment
Nurture and develop the next generation of scientific leaders
Give back to and improve our communities

Vaccinations & Safety Protocols

Battelle may require employees, based on job duties, work location, and/or its clients’ requirements to follow certain safety protocols and to be vaccinated against a variety of viruses, bacteria, and diseases as a condition of employment and continued employment and to provide documentation that they are fully vaccinated. If applicable, Battelle will provide reasonable accommodations based on a qualified disability or medical condition through the Americans with Disabilities Act or the Rehabilitation Act or for a sincerely held religious belief under Title VII of the Civil Rights Act of 1964 (and related state laws).

Battelle is an equal opportunity employer. We provide employment and opportunities for advancement, compensation, training, and growth according to individual merit, without regard to race, color, religion, sex (including pregnancy), national origin, sexual orientation, gender identity or expression, marital status, age, genetic information, disability, veteran-status veteran or military status, or any other characteristic protected under applicable Federal, state, or local law. Our goal is for each staff member to have the opportunity to grow to the limits of their abilities and to achieve personal and organizational objectives. We will support positive programs for equal treatment of all staff and full utilization of all qualified employees at all levels within Battelle.

The above statements are intended to describe the nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, activities and skills required of staff members. No statement herein is intended to imply any authorities to commit Battelle unless special written permission is granted by Battelle's Legal Department.

For more information about our other openings, please visit www.battelle.org/careers