Clinical Trials Assistant- Shockwave (Reducer)

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

R&D Operations

Job Sub Function:

Clinical/Medical Operations

Job Category:

Business Enablement/Support

All Job Posting Locations:

New Brighton, Minnesota, United States of America

Job Description:

Johnson & Johnson is hiring for a Clinical Trials Assistant– Shockwave (Reducer) to join our team located in New Brighton, MN.

Shockwave Medical is a fast-growing medical device company focused on revolutionizing the treatment of advanced cardiovascular disease. With the innovative Shockwave Reducer System, we are creating new opportunities for patients and physicians in the treatment of refractory angina – long-lasting, debilitating chest pain that cannot be controlled by traditional medicine or surgical procedures and affects millions of people world-wide.

To support the growing Shockwave Reducer business, we are establishing a facility in New Brighton, MN focused on the Reducer. We are actively seeking motivated individuals who bring relevant industry experience and are enthusiastic about learning and growing within the Reducer business. Learn more at https://www.jnj.com/.

Position Overview

The Clinical Trial Assistant supports the clinical study team with respect to general study oversight, project communications, study payments and invoice processing, file management, and study supply shipments. Project communications include site correspondence, clinical study updates internally and with vendor partners, project reviews, and managing team agendas and meeting minutes. The individual will maintain, update, and may create various databases for clinical activity tracking. Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites.

Essential Job Functions

• Responsible for tracking and processing vendor and site payments timely
• Responsible for shipment of study supplies which may include study device shipment and ensures that supplies are adequate for investigator sites
• As instructed, periodically review the Trial Master File (TMFs) to ensure accuracy and completeness
• Assists, as directed, with review of regulatory documents from study sites; ensures completeness and accuracy
• Supports CRAs with maintaining tracking information for study activities
• Act as a central contact for the clinical team for designated project communications, correspondence, training, and associated documentation
• Handles, distributes, files and archives clinical documentation and reports
• Responsible for updating study wide distribution and contact lists
• Responsible for maintenance of Clinical Calendar, Study Mailbox, DropBox, CT.gov, etc.
• Assists, as directed, with taking and issuing meeting agendas and minutes for designated clinical team meetings
• Helps prepare Study Coordinator and Investigator Meetings, as needed
• Completes assigned responsibilities in an accurate and timely manner and may support multiple studies
• Performs administrative tasks to support team members with clinical trial execution, as needed
• All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with the company’s Standard Operating Procedures
• Other duties as assigned.

Requirements:

• High School diploma required; Associate or bachelor’s degree in biological sciences, health care management, life sciences research, or other relevant area of study preferred
• 2+ years’ experience in an administrative support role
• Experience directly supporting clinical research or relevant experience in medical/scientific area preferred
• Strong verbal and written communication skills with a high attention to detail
• Working knowledge of GCP and FDA regulations is a plus
• Experience with databases and data systems
• Proficient working knowledge of Microsoft Word, Excel, PowerPoint
• Ability to work in a fast-paced environment while managing multiple priorities
• Operate as a team and/or independently while demonstrating flexibility to changing requirements.
• Effective time management and organizational skills
• Demonstrated success in problem solving
• Demonstrates good judgment and maturity working within teams
• Ability to establish and maintain effective working relationships with all stakeholders

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.

Required Skills:

Preferred Skills:

Administrative Support, Analytical Reasoning, Business Behavior, Clinical Operations, Clinical Research and Regulations, Clinical Trial Designs, Communication, Data Analysis, Execution Focus, Innovation, Laboratory Operations, Preclinical Research, Process Oriented, Project Administration, Regulatory Compliance, Research and Development, Research Documents

The anticipated base pay range for this position is :

$41,000.00 - $66,700.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are 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.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits