Johnson & Johnson MedTech a member of Johnson & Johnson's Family of Companies, is recruiting for a Sr. Clinical Research Specialist located in Irvine, CA.
The J&J MedTech Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.
Position Summary:
Under direct supervision, this Associate Clinical Research Specialist will be responsible for supporting one or several clinical trials and projects within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
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Essential Functions/Responsibilities:
Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
- Serves as a Clinical Research Specialist within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones, for Johnson & Johnson MedTech under supervision;
- Participates in the feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures;
- May serve as the primary contact for clinical trial sites (e.g. site management);
- Assists in the development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports);
- Supports applicable trial registration (e.g. www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed;
- Coordinates and executes ordering, tracking, and accountability of investigational devices and trial materials;
- Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel;
- Interfaces and collaborates with Clinical Research Associates (CRAs);
- Assists in overseeing and supports the development and execution of Investigator agreements and trial payments;
- Assists in clinical data review to prepare data for statistical analyses and publications;
- May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;
- May provide on-site procedural protocol compliance and data collection support to the clinical trial sites;
- Assists in tracking assigned project budgets;
- May perform other duties assigned as needed;
- Is responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;
- Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;
- Should develop a strong understanding of the pipeline, product portfolio and business needs;
- Generally manages work with supervision. Independent decision-making for simple situations but requires guidance for complex situations.
• Development of clinical study safety management plan (SMP) and study-specific safety flow in accordance with internal procedures and applicable safety regulations for clinical research;
- Coordinates the collection of required information on safety events with the clinical study team;
- Cooperates with cross-functional teams (Research & Development, Complaint Handling, Quality/Regulatory, Medical Affairs, Medical Safety) to ensure safety and complaint reporting compliance for each clinical study;
- Coordinates review of clinical safety data with the clinical study team, Medical Affairs or Medical Safety team;
• Contributes to safety and ad-hoc regulatory reports for reporting to internal stakeholders, investigators, ethics committees and authorities;
Qualifications
Qualifications:
Experience
- Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,...).
- Clinical/medical background is a plus.
Required:
- A minimum of a Bachelor's Degree in Life Science, Physical Science, Nursing, or Biological Science with 5 years of relevant experience OR a MS or PhD with at least 1 year of relevant experience
- Previous experience in clinical research required
- Good understanding of clinical research science and processes, clinical trends, and global clinical trial regulations;
- Proven track record in supporting clinical projects within clinical/ surgical research setting, on time, and in compliance to SOPs and regulations;
- Written and oral English communication skills.
- Presentation and technical writing skills;
Preferred:
• Class III Medical Device Experience and/or pharmaceutical industry experience
• Well-versed in audits, compliance, and quality reviews
• Familiar with long-term studies that go up to 10 years
Other:
• Primary location for this position is Hybrid - Flex at Irvine, California.
• Ability to travel approximately 10-20% depending on the phase of the program.
At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
The anticipated base pay range for this position is $89,000- 143,750
This job posting is anticipated to close on 3/12/25. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.