Clinical Research Associate ensuring sites conduct studies and reporting data accurately. Monitoring, site management, and collaboration with the study team.
About the role
- Clinical Research Associate I managing clinical trial operations supporting the clinical trial team. Ensuring compliance with clinical trial protocols, SOPs, and GCPs at investigative sites.
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.
- 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.
- Develop monitoring skills to ensure site staff complete data entry and resolve queries within expected timelines, and accuracy, validity and completeness of data collected at trial sites.
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).
- Strong computer skills in appropriate software and related company clinical systems
- Proficient in speaking and writing the country language, English
- Presentation and influencing skills
- Strong organizational skills (e.g., able to manage multiple sub-projects and tasks simultaneously and consistently meet all associated deadlines).
- A valid Driver's License issued in one of the 50 United States and a good driving record is required.
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 in 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
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