Clinical Trials Assistant- Shockwave (Reducer)

Johnson & Johnson Innovative Medicine • New Brighton, MN

1d • Onsite

About The Position

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. 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.

Requirements

• High School diploma required
• 2+ years’ experience in an administrative support role
• 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

Nice To Haves

• Associate or bachelor’s degree in biological sciences, health care management, life sciences research, or other relevant area of study preferred
• Experience directly supporting clinical research or relevant experience in medical/scientific area preferred

Responsibilities

• 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.

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 period
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED