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:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Clinical Development & Research – Non-MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Irvine, California, United States of America

Job Description:

Our J&J MedTech Electrophysiology clinical team is currently recruiting for a Clinical Research Specialist. This role's preferred location is in Irvine, California however we are open to remote candidates within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

This Clinical Research Specialist will be responsible for supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.

Job 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 J&J Medtech Electrophysiology 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.

Qualifications:

Education

· Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.

Experience

· BS with at least 2 years, MS and PhD with at least 1 year of relevant experience preferred.

· Previous experience in clinical research or equivalent is desired.

· Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).

· Clinical/medical background is a plus.

· Medical device experience is a plus.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

Functional and Technical Competencies:

· 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;

· Presentation and technical writing skills;

· Written and oral English communication skills.

Leadership Competencies:

Leadership required in alignment with J&J Leadership Imperatives:

· Connect - Develop collaborative relationships with key internal and external stakeholders.

· Shape - Actively participate in departmental process improvement activities.

· Lead - Take ownership in critical scientific thinking and development of self and engage in transparent and constructive conversations.

· Deliver - Strive to ensure all deliverables on allocated studies are met on time, within budget and in compliance to SOPs and regulations

LOCATION & TRAVEL REQUIREMENTS

· Primary location for this position is Irvine, CA. At management discretion, the position may be performed remotely.

· Ability to travel approximately 20% depending on the phase of the program.

EXTERNAL INTERACTIONS

· Frequent (several times per month) interaction with physicians and research staff at centers selected for involvement in clinical research as well as those being evaluated.

· May have regular interaction with third party vendors supporting clinical studies as applicable per clinical trial.

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, Clinical Data Management, Clinical Evaluations, Clinical Trial Protocols, Coaching, Consulting, Data Savvy, Drug Discovery Development, Good Clinical Practice (GCP), Medicines and Device Development and Regulation, Persistence and Tenacity, Regulatory Affairs Management, Research Documents, Resource Management, Safety-Oriented, Scientific Research, Technologically Savvy

The anticipated base pay range for this position is :

$89,000 - $143,000

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 Holiday pay, including Floating Holidays – up to 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.