At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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. CRA Shockwave Medical to join our team. The position is FULLY REMOTE and can sit anywhere in the US.

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments. Ready to join a team thats 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

• Bachelors 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

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 () or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

US: $89000- $143750 / Bay Area: $103000-$165600

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees and/or eligible dependents are 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. Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Companys 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 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 Condolence Leave 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave 10 days Volunteer Leave 4 days Military Spouse Time-Off 80 hours Additional information can be found through the link below. Experience:

Senior IC