Senior Clinical Research Associate - Shockwave Medical

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

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 & 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 contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

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