6+ month contract

BS Degree (Biomedical Engineering preferred), 3+ years of medical device industry experience, 1 year of clinical research experience OR investigational medical device exp, strong Technical Writing skills

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.

• · 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

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.modis.com/en-us/candidate-privacy/

The Company will consider qualified applicants with arrest and conviction records.

#GRPB

Job Type: Contract

Pay: $40.00 - $45.00 per hour

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• Columbus, OH: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Preferred)

Work Location: In person

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