Job Function:
R&D Operations

Job Sub Function:
Clinical Trial Project Management

Job Category:
Professional

All Job Posting Locations:
Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Sr. Clinical Research Associate - Shockwave Medical to join our team. This role is fully remote in the United States.

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview

The Sr. Clinical Research Associate (Sr. CRA) will be responsible for establishing, managing and meeting milestones of clinical studies in compliance with applicable clinical and regulatory standards and in alignment with business needs. They will be accountable for clinical project management activities, for coordination with cross-functional counterparts and contract research organizations (CROs) in global studies. This position requires strategic, project and resource management responsibilities for the assigned clinical program(s) to evaluate the safety and effectiveness of interventional products. This work is accomplished with moderate supervision and requires a motivated, self-starter who can work independently once projects are assigned.

Essential Job Functions

• Participate in the design and execution of global studies for regulatory submissions, reimbursement and product adoption, including clinical study documents (protocol, case report forms, etc.), study implementation and data management.
• Manage study preparation, activation, enrollment, submission, maintenance and closure activities.
• Participate in administrative activities associated with the clinical department including procedures, training of key personnel and preparation and maintenance of objectives and budgets.
• Interface with representatives from key functional groups to drive product development within core teams, and clinical wide or cross-departmental initiatives.
• Ensures appropriate oversight of clinical study by internal and external resources including, but not limited to monitoring staff, CROs and core laboratories.
• Manage key study investigators; foster and maintain strong relationships through direct interactions with medical advisors and clinical leaders.
• Negotiate contracts with hospitals, consultants, investigators, CROs, database management firms and outside suppliers.
• Supervise training of investigators, site staff and field clinical staff.
• Evaluates clinical and adverse event data during the conduct of the study and for completion of clinical study reports and other technical documents.
• Ensures quality by maintaining compliance, reviewing device complaints, reviewing audit reports and implementing corrective actions.
• Regularly communicates study status to senior management and represents organization to key customers.
• Other duties as assigned.

Requirements

• Bachelor's Degree in a scientific field of study with a minimum of 5 years' experience directly supporting clinical research
• Working knowledge of Good Clinical Practice (GCP), FDA, ISO and other applicable regulations)
• Knowledge of FDA and international regulations and guidelines including, but not limited to, clinical strategy, GCPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance and medical device reporting
• ACRP or SOCRA clinical research certification preferred
• Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology
• Ability to travel up to 25% domestically and internationally
• High attention to detail and accuracy
• Computer skills (MS Office products, word processing, spreadsheets, etc.)
• Finance and budgeting knowledge
• Good prioritization and organizational skills
• Excellent critical thinking skills
• Excellent influencing and negotiation skills
• High energy and results-oriented individual who is mature and successful in a business environment
• Proactive and "can do" attitude
• Works effectively on cross-functional teams
• Effective written, verbal and presentation skills with all levels of management and organizations
• Operates both as a team and independently, with adaptability to changing requirements
• Ability to work in a fast-paced environment, managing multiple priorities

Required Skills:

Preferred Skills:
Business Behavior, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Give Feedback, Laboratory Operations, Medical Knowledge, Mentorship, Problem Solving, Process Oriented, Professional Ethics, Project Integration Management, Project Management, Research and Development, Research Ethics

The anticipated base pay range for this position is :
$106,000.00 - $170,200.00

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