Sr. Clinical Research Associate- Shockwave Medical (Remote)

Johnson & Johnson Innovative Medicine•Santa Clara, CA

1d•Remote

About The Position

Johnson & Johnson is hiring for a Sr. Clinical Research Associate– Shockwave Medical to join our team. The position is FULLY REMOTE and can sit anywhere in the US. 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 https://www.jnj.com/. 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.

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

Responsibilities

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.

Benefits

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