What you'd actually do

Manage study preparation, activation, enrollment, submission, maintenance and closure activities.

Ensures appropriate oversight of clinical study and study sites 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.

Evaluates clinical and adverse event data during the conduct of the study and for completion of clinical study reports and other technical documents.

Skills

Required

Bachelor’s Degree in a scientific field of study
minimum of 5 years’ experience directly supporting clinical research for medical device studies
Working knowledge of Good Clinical Practice (GCP), FDA, ISO and other applicable regulations)
Knowledge of FDA and international regulations and guidelines
Strong written, oral, and interpersonal communication skills
proficient knowledge of medical terminology
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
Works effectively on large study teams and cross-functional teams
Effective written, verbal and presentation skills with all levels of management and organizations
Ability to work in a fast-paced environment, managing multiple priorities

Nice to have

Prior experience with, or strong working knowledge of, Class III cardiovascular medical devices
ACRP or SOCRA clinical research certification
Ability to travel up to 25% domestically and internationally
High attention to detail and accuracy
Proactive and “can do” attitude
Operates both as a team and independently, with adaptability to changing requirements

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

**Job Function: **

R&D Operations

**Job Sub Function: **

Clinical Trial Project Management

Job Category:

Professional

All Job Posting Locations:

New Brighton, Minnesota, United States of America, Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Sr. Clinical Research Associate- Shockwave (Reducer) to join our team. The position is FULLY REMOTE and can sit anywhere in the US.

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.

Position Overview

The Sr. Clinical Research Associate (Sr. CRA) will be responsible for 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 study and site management activities, for coordination with cross-functional counterparts and contract research organizations (CROs) in global studies. 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 development of 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.
Ensures appropriate oversight of clinical study and study sites 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 and site 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 with status updates to senior management and represents organization to study sites.
Other duties as assigned.

Qualifications

Bachelor’s Degree in a scientific field of study with a minimum of 5 years’ experience directly supporting clinical research for medical device studies
Prior experience with, or strong working knowledge of, Class III cardiovascular medical devices preferred
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 large study teams and 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 (ra-employeehealthsup@its.jnj.com) 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