Job Description

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

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:

We are seeking the best talent for an Investigator Initiated Study Specialist . This role will work a Hybrid/Flex schedule and must live within a commutable distance to Irvine, CA.

Purpose : Reporting to Clinical Science and External Research Leaders, the Investigator Initiated Study Specialist will handle external research programs, including the Investigator-Initiated Study Program, to support the evidence generation and dissemination strategy of assigned products. This person will support clinical study coordination and other research-related tasks to support applicable Company and Departmental procedures.

You will be responsible for :

• Coordination of postmarket clinical studies, including company-sponsored studies, investigator- initiated studies, and collaborative studies.
• Lead the Investigator-Initiated Study Program, including working with external investigators and internal teams to handle the flow of applications through the review/approval process and securely maintaining records.
• Coordination of execution of approved studies, including: confirming incorporation of specific conditions in the study protocol and contract; working with appropriate contracting groups, such as Contract and Compliance Services, to document that the Fair Market Value of the final budget is at or below the budget maximum approved by the Committee; establishing final timelines with the Investigator and confirming alignment with the original application; and verifying that all study conditions have been met prior to study closeout.
• Serving as the Clinical Science & External Research contract specialist responsible for: crafting study-specific budget and payment schedule; drafting the clinical study agreement in consultation with the appropriate study manager; collaborating closely with the site regarding clinical study agreement negotiations; coordinating Legal, Healthcare Compliance, and other appropriate department reviews; handling execution of final clinical study agreement by both sponsor and site; and uploading the fully implemented contract onto the contract management database.
• Handling device orders, shipments, and returns
• Coordination contracting and act as PO preparer, new provider finance process and all invoice processing. Collaborating with finance on quarterly updates
• Schedules meetings, accurately drafts and records meeting minutes, and follows-up on action items.
• Works with global Medical/Clinical colleagues in daily management of research projects in countries outside of the United States.
• Running Clinical Events Committees for assigned clinical studies.
• Coordinating investigator meetings.
• Communicating business-related issues or opportunities to Management in a timely manner.
• Updates leadership on investigator-initiated study and collaborative study progress.
• Ensures personal and Company compliance with all Government and Company regulations, policies, and procedures.
• Performs other assigned duties, as needed.

Qualifications / Requirements :

• Minimum of a Bachelor’s degree in a relevant scientific field required .
• Minimum of 2+ years of experience in clinical study management in Medical Device, Pharmaceutical, Biotechnology, or Clinical Research Organization industries.
• Effective time management, organizational and prioritization skills.
• Strong project management skills with meticulous attention to detail.
• Professional verbal and written communication skills.
• Professional experience and proficiency in using Microsoft Office tools, (Excel, PowerPoint, Teams, etc)
• Proven record of collaborating in a cross-functional work environment.
• Highly motivated, responsible, fast-learner, and team-oriented collaborator willing to take ownership of their contributions to the advancement of the collective Clinical Science & External Research goals and objectives.
• Medical device experience; cardiovascular experience is a plus .
• Experience with clinical research contract negotiation preferred .
• Experience interacting with external investigators desired .

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 ([email protected]) or contact AskGS to be directed to your accommodation resource.

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The anticipated base pay range for this position is:

The anticipated base pay range for this position is $89,000 to $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)). 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.

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