Hybrid Clinical Research Associate I

at Johnson & Johnson

• Job title: Clinical Research Associate I
• Job type: Full Time
• Experience level: Junior, Mid level
• Salary: $76,000 - $121,900 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Cincinnati, United States

About the role

• Clinical Research Associate I managing clinical trials and ensuring compliance with protocols. Supporting the clinical trial team at Johnson & Johnson MedTech with operational activities.

Responsibilities

• On behalf of Clinical Affairs, Robotics and Digital Solutions, within Johnson & Johnson MedTech Surgery, the Clinical Research Associate I (CRA I) serves as the primary contact point between the Sponsor and the Investigational Site.
• The CRA I responsibilities include supporting the clinical trial team in study operations activities.
• The CRA I may be assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and applicable regulations and guidelines from study start-up through site closure.
• Support clinical trial operational activities such as device management and study budget tracking.
• May act as primary local company contact for assigned sites for specific trials.
• May participate in site feasibility and/or pre-trial site assessment visits.
• Attend/participate in investigator meetings as needed.
• Partners with the clinical trial team to execute activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies.
• May ensure site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases.
• Work in close collaboration with Clinical Research Manager for the activities during site activation phase in order to speed up the process and activate the site in shortest possible timeframe.

Requirements

• A Bachelor’s Degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science.
• Bachelor's degree with at least 3 years of relevant experience; Master’s or PhD/MD/PharmD with at least 1 year of relevant experience.
• Previous clinical research experience required.
• Previous medical device monitoring or equivalent experience required.
• Requires understanding and application of regulations and standards applied in clinical research areas and medical devices/combination products.
• Relevant industry certifications preferred (e.g., CCRA, RAC, CDE).
• Requires experience and knowledge working with computer systems (Microsoft Office – Excel, Word, PowerPoint and Outlook).

Benefits

• medical
• dental
• vision
• life insurance
• short- and long-term disability
• business accident insurance
• group legal insurance
• consolidated retirement plan (pension)
• savings plan (401(k))
• vacation –120 hours per calendar year
• sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• holiday pay, including Floating Holidays –13 days per calendar year
• work, personal and family time - up to 40 hours per calendar year
• parental leave – 480 hours within one year of the birth/adoption/foster care of a child
• condolence leave – 30 days for an immediate family member: 5 days for an extended family member
• caregiver leave – 10 days
• volunteer leave – 4 days
• military spouse time-off – 80 hours