Clinical Research Associate I

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function

R&D Operations

Job Sub Function

Clinical Trial Support

Job Category

Professional

All Job Posting Locations:

Cincinnati, Ohio, United States of America, Santa Clara, California, United States of America

Job Description

About Surgery

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. 

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

We are searching for the best talent for Clinical Research Associate I.

Overall 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.

Key Job Activities

Principal Clinical Study Site Management Tasks

• 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.
• Develops 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.
• Develops monitoring skills to ensure that all Adverse Events (AE) /Serious Adverse Events (SAEs )/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.
• Maintain complete, accurate and timely data and essential documents in relevant systems utilized for trial management.
• If conducting monitoring visits, fully document trial-related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders.
• Review study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.
• Collaborate with the Clinical Research Manager for documenting and communicating site/study progress and issues to trial central team.
• Attend regularly scheduled team meetings and trainings.
• Comply with relevant training requirements. Act as local expert in assigned protocols.
• Develops therapeutic knowledge sufficient to support role and responsibilities.
• May prepare trial sites for close out, conduct final close out visit.
• Establish and maintain good working relationships with internal and external stakeholders, investigators, trial coordinators and other site staff.
• May contribute to process improvement and training.
• Lead and/or participate in special initiatives as assigned.
• May assume additional responsibilities or special initiatives such as “Champion” or “Subject Matter Expert”. This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned. May collaborate with contractors/vendors, and company personnel as needed.
  
  

Administrative Tasks

• CRA I knows, understands, incorporates, and complies with all applicable laws and regulations relating to J&J business activities, and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.
• May be asked to provide additional support to Clinical Affairs, Robotics and Digital Solutions staff, as needed.
  
  

Job Qualifications

Education

• A Bachelor’s Degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science.
  
  

Experience

• 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).
  
  

Knowledge

• Requires experience and knowledge working with computer systems (Microsoft Office – Excel, Word, PowerPoint and Outlook).
  
  

Additional Requirements

• 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).
• Willingness to travel 50%, approximately 2-3 days per week, with overnight stays (1-2 nights on average), is required.
• A valid Driver's License issued in one of the 50 United States and a good driving record is required.
  
  

Additional Information

• The expected base pay range for this position is $76,000 - $121,900/ annually .
• The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program.
• Employees are eligible for the following time off benefits:
• 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
• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
  
  

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.

Required Skills

Preferred Skills:

Analytical Reasoning, Business Behavior, Business English, Clinical Data Management, Clinical Trials, Clinical Trials Operations, Execution Focus, Issue Escalation, Laboratory Operations, Process Improvements, Process Oriented, Project Support, Regulatory Environment, Research and Development, Research Ethics, Study Management, Time Management

The anticipated base pay range for this position is :

76000-121,900