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 Project Management **Job Category:** Professional **All Job Posting Locations:** US331 CA Irvine - 31 Technology Dr **Job Description:** 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. **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:** **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. **The anticipated base pay range for this position is :** 89,000- 143,750 Additional Description for Pay Transparency: 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 – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year