Job Description

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

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:

Santa Clara California United States of America

Job Description:

Johnson & Johnson is hiring for a Clinical Research Associate II- Shockwave (Reducer) 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 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 Clinical Research Associate II (CRA II) is responsible for facilitating in-house set up activation maintenance and closure of global clinical trials while gaining experience in clinical trial management processes. The CRA II will work closely with Investigators Site Personnel and Vendors to ensure compliance with protocol and overall clinical collaboration with the Clinical Research Manager the CRA II maintains consistent CRF data quality and discrepancy interpretation across sites. The CRA II will develop a basic understanding of the disease and indication.

Essential Job Functions

• May participate in study design and study set up activities

• May conduct site visits (pre-study initiation interim and close-out visits) to ensure protocol compliance accurate and thorough data collection and appropriate study conduct
• Participate in the review of monitoring visit reports for completeness
• Supports development of study training and may provide study site training to site personnel
• Provides study training to internal employees as applicable
• Assists in development of CRF design CRF guidelines and supports database development when applicable
• Develop study tools and guidelines to be utilized by study sites
• Develops basic knowledge of the process used to evaluate and select potential investigators and sites
• Develops basic knowledge of the process used to evaluate and select potential vendors as applicable
• Interacts with field monitors/CRO CRAs investigators and study coordinators through frequent communication (written and verbal) and maintains effective management of study issues
• Drafts informed consents as applicable
• Reviews sites informed consent forms against the consent template for presence of all GCP requirements and protocol specific information and revisions as needed. Also reviews the consent for accuracy and ensures that the consent is written in language that subjects will understand
• Coordinates and reviews regulatory documents from study sites; ensures completeness and accuracy facilitates translation as needed
• Ensure study records are auditable in-house
• Responsible for authoring internal documents and may author portions of clinical study reports or clinical evaluation reports
• Develops basic knowledge of the investigator contract budget and payment process including legal language and document structure as it impacts assigned studies
• May be responsible for initiating and tracking quarterly site payments and reconciling study invoices
• Communicates status of trial to manager and team
• May be responsible for development or revision of SOPs or work instructions
• Appropriately represents functional area
• Other duties as assigned

Qualifications

• Bachelors degree in science or healthcare with a minimum of 2 years of medical device industry experience directly supporting clinical research in a Sponsor role
• Must have excellent verbal and written communication skills
• High attention to detail and organizational skills are necessary
• Basic understanding of peripheral and coronary artery disease and therapies preferred
• Working knowledge of GCP FDA ISO and other applicable regulations
• Ability to travel 10-20% domestically and internationally
• Experience with EDC Data Management Systems
• Ability to work in a fast-paced environment while managing multiple priorities
• ACRP or SOCRA clinical research certification preferred
• Operate as a team and/or independently while demonstrating flexibility to changing requirements

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.

Required Skills:

Preferred Skills:

Analytical Reasoning Analytics Dashboards Business Behavior Clinical Data Management Clinical Research and Regulations Clinical Trial Designs Clinical Trials Execution Focus Laboratory Operations Medical Knowledge Process Oriented Professional Ethics Project Integration Management Project Management Research and Development Research Ethics Training Administration

The anticipated base pay range for this position is :

$87000.00 - $140300.00

Additional Description for Pay Transparency:

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 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: - Experience:

IC

Job Tags

Full time, Contract work, Interim role, Local area, Immediate start, Remote work

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