Clinical Research Associate II- Shockwave (Reducer)
Johnson & Johnson, Santa Clara, CA, United States
Job Details
Job Function: R&D Operations
Job Sub Function: Clinical Trial Project Management
Job Category: Professional
Job Posting Locations: Santa Clara, California, United States of America
Position Overview
Clinical Research Associate II – Shockwave (Reducer) responsible for facilitating in‑house setup, activation, maintenance, and closure of global clinical trials. Gains experience in clinical trial management, works closely with Investigators, Site Personnel and Vendors to ensure protocol compliance, data quality, and overall clinical objectives.
Essential Job Functions
May participate in study design and setup activities.
May conduct site visits (pre‑study, initiation, interim and close‑out) to ensure protocol compliance, accurate data collection, and appropriate study conduct.
Participate in the review of monitoring visit reports for completeness.
Support development of study training and provide study site training to site personnel as needed.
Provide study training to internal employees as applicable.
Assist in development of CRF design, CRF guidelines and support database development when applicable.
Develop study tools and guidelines to be utilized by study sites.
Develop basic knowledge of the process used to evaluate and select potential investigators and sites.
Develop basic knowledge of the process used to evaluate and select potential vendors as applicable.
Interact with field monitors/CRO CRAs, investigators and study coordinators through frequent communication and maintain effective management of study issues.
Draft informed consents as applicable.
Review site’s informed consent forms for GCP requirements and protocol information, ensuring accuracy and clarity.
Coordinate and review regulatory documents from study sites, ensuring completeness, accuracy and facilitating translation as needed.
Ensure study records are auditable in‑house.
Responsible for authoring internal documents and may author portions of clinical study reports or evaluation reports.
Develop basic knowledge of investigator contract, budget and payment process including legal language and document structure.
Possibly initiate and track quarterly site payments and reconcile study invoices.
Communicate status of trial to manager and team.
Possibly develop or revise SOPs or work instructions.
Appropriately represent functional area.
Other duties as assigned.
Qualifications
Bachelor’s degree in science or healthcare with at least 2 years of medical device industry experience supporting clinical research in a Sponsor role.
Excellent verbal and written communication skills.
High attention to detail and organizational skills.
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.
Required Skills
No specific required skills listed beyond the qualifications.
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
Salary & Benefits
Anticipated base pay range: $87,000.00 – $140,300.00.
Additional benefits: Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). The position is eligible for the Company’s long‑term incentive program.
Time off benefits include:
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year (48 for Colorado residents; 56 for Washington residents)
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 birth/adoption/foster care of a child
Bereavement leave – 240 hours (40 for extended family member per calendar year)
Caregiver leave – 80 hours in a 52‑week rolling period (10 days)
Volunteer leave – 32 hours per calendar year
Military spouse time‑off – 80 hours per calendar year
Equal Opportunity & Accessibility
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.
Johnson & Johnson is committed to providing an inclusive interview process. If you have a disability and would like accommodations, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS for assistance.
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Job Function: R&D Operations
Job Sub Function: Clinical Trial Project Management
Job Category: Professional
Job Posting Locations: Santa Clara, California, United States of America
Position Overview
Clinical Research Associate II – Shockwave (Reducer) responsible for facilitating in‑house setup, activation, maintenance, and closure of global clinical trials. Gains experience in clinical trial management, works closely with Investigators, Site Personnel and Vendors to ensure protocol compliance, data quality, and overall clinical objectives.
Essential Job Functions
May participate in study design and setup activities.
May conduct site visits (pre‑study, initiation, interim and close‑out) to ensure protocol compliance, accurate data collection, and appropriate study conduct.
Participate in the review of monitoring visit reports for completeness.
Support development of study training and provide study site training to site personnel as needed.
Provide study training to internal employees as applicable.
Assist in development of CRF design, CRF guidelines and support database development when applicable.
Develop study tools and guidelines to be utilized by study sites.
Develop basic knowledge of the process used to evaluate and select potential investigators and sites.
Develop basic knowledge of the process used to evaluate and select potential vendors as applicable.
Interact with field monitors/CRO CRAs, investigators and study coordinators through frequent communication and maintain effective management of study issues.
Draft informed consents as applicable.
Review site’s informed consent forms for GCP requirements and protocol information, ensuring accuracy and clarity.
Coordinate and review regulatory documents from study sites, ensuring completeness, accuracy and facilitating translation as needed.
Ensure study records are auditable in‑house.
Responsible for authoring internal documents and may author portions of clinical study reports or evaluation reports.
Develop basic knowledge of investigator contract, budget and payment process including legal language and document structure.
Possibly initiate and track quarterly site payments and reconcile study invoices.
Communicate status of trial to manager and team.
Possibly develop or revise SOPs or work instructions.
Appropriately represent functional area.
Other duties as assigned.
Qualifications
Bachelor’s degree in science or healthcare with at least 2 years of medical device industry experience supporting clinical research in a Sponsor role.
Excellent verbal and written communication skills.
High attention to detail and organizational skills.
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.
Required Skills
No specific required skills listed beyond the qualifications.
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
Salary & Benefits
Anticipated base pay range: $87,000.00 – $140,300.00.
Additional benefits: Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). The position is eligible for the Company’s long‑term incentive program.
Time off benefits include:
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year (48 for Colorado residents; 56 for Washington residents)
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 birth/adoption/foster care of a child
Bereavement leave – 240 hours (40 for extended family member per calendar year)
Caregiver leave – 80 hours in a 52‑week rolling period (10 days)
Volunteer leave – 32 hours per calendar year
Military spouse time‑off – 80 hours per calendar year
Equal Opportunity & Accessibility
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.
Johnson & Johnson is committed to providing an inclusive interview process. If you have a disability and would like accommodations, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS for assistance.
#J-18808-Ljbffr