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:

Irvine, California, United States of America, New Brunswick, New Jersey, United States of America

Job Description:

Purpose:

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.

You will be responsible for:

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 an Associate 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;
• Serves as as the primary contact for clinical trial sites (e.g. site management);
• May assist in the development of clinical trial documents (e.g. CCGs, study protocol, informed consents templates, 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;
• May interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel;
• May also be responsible for processing, tracking, and filing of study documents, and management of the Trial Master File within the clinical projects.
• 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;
• 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:

• Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).
• Clinical/medical background is a plus.
• A minimum of a Bachelor’s Degree in Life Science, Physical Science, Nursing, or Biological Science with at least 3 years of relevant experience
• Experience supporting clinical projects within a clinical/surgical research setting, on time, and in compliance to SOPs and regulations
• 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 Fully Remote (occasional travel to Irvine, California may be requested)
• Ability to travel approximately 10-20% depending on the phase of the program

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 and 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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$61,000- $98,000

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)). 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 Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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