Clinical Research Associate (Cra)

Job Title:
Clinical Research Associate (CRA)
Type of Position:
6-month contract position initially (likely to be extended, ultimately good chance of going direct hire)
Job Location:
Columbus, OH (near OSU Campus)
Compensation:
$43.00/hr to $51.00/hr (negotiable, depending on experience). Overtime paid at 1.5x over 40 hours.
Benefits:
Available (health insurance, dental, vision, 401k, etc)
Job Description / Duties:
HRU Technical Resources has partnered with an independent not-for-profit organization that advances science and technology to have the greatest impact on our society and economy. We are currently seeking a Clinical Research Associate (CRA) to support our Medical Device Solutions team. 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 / Job Duties:
•    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.
Preferred Qualifications:
•    Five years of specific experience as a Clinical Research Associate or equivalent for investigational medical devices.
Work Environment / Physical Requirements:
•    This role will work normal business hours (day shift) – Monday to Friday.
•    Offer will be contingent upon passing a background check and drug screen.