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

Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Project Management

Job Category:

Professional

All Job Posting Locations:

Aurora, Illinois, United States, Austin, Texas, United States, Baltimore, Maryland, United States, Cedar Rapids, Iowa, United States, Colorado Springs, Colorado, United States of America, Danvers, Massachusetts, United States of America, Durham, North Carolina, United States, Ft. Lauderdale, Florida, United States, Lakeland, Florida, United States, New Brunswick, New Jersey, United States of America

Job Description:

​ 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.

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for a Clinical Research , located in Remote in USA. Remote work options may be considered on a case-by-case basis and if approved by the Company.

#Li-Hybrid

#Li-Remote

Reporting to the Clinical Research Associate Manager, the person in this role is responsible for the management of day-to-day aspects of investigational site activities on assigned clinical trials. The CRA should ensure compliance with international guidelines, local regulations and corporate policies and procedures. Successful candidates will be forward thinking, anticipate needs and be able to work well in a fast-paced environment, either independently or as part of a collaborative team. This person will be fully engaged and busy from the first day, and we guarantee there will never be a dull moment. Our team focuses on future development of the Impella platform, including clinical studies, data science and new clinical and physiological applications.

• Perform study start-up and conduct activities including ICF review that meets regulatory requirements, creating study specific essential document lists, managing and communicating the status of study progress and activities

• Identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge and develop processes to mitigate reoccurrence throughout study phases

• Conduct reviews of documentation needed for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Abiomed internal SOPs, and US and OUS regulations

• Assess current processes, identify opportunities and propose solutions to improve efficiencies within and across related functional areas

• Partner with cross-functional team (e.g., clinical data management, medical teams) with query management, data reviews and resolution

• Conduct site initiation visits; train site personnel on sponsor and regulatory requirements for study conduct;participate in and/or conduct site meetings and prepare site initiation visit reports and associated documentation.

• Conduct site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with study

• Assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices), PHI (Personal Health Information) and regulatory requirements.

• Manage monitoring progress of contract & CRO CRAs for respective sites.

• Provide oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Committees, Clinical Operations(e.g. Contracts), and recommend and develop process improvements.

• Verify trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded.

• Validate investigational device accountability by tracking the history of investigational devices from Abiomed to the field sites and through final disposition.

• Develop and deliver training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities.

• Contribute to the development of clinical protocols, informed consent forms, and case report forms.

• Edit/amend informed consent documents.

• Job Qualifications:

• Bachelor's Degree or equivalent in related field with 3 years of previous field monitoring experience required

• Excellent written and verbal communication, presentation, interpersonal, and analytical skills required

• Proven expertise in MS Office Suite, including Word, Excel, Adobe

• Demonstrated problem-solving and critical thinking skills

• Strong understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise

• Understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting

• Ability to communicate and relate well with key opinion leaders and clinical personnel

• Experience working in a medical device or regulated industry preferred

• Experience with electronic data capture preferred

• Clinical research certification (ACRP or SoCRA clinical coordinator/ CRA certification) preferred

• Ability to travel up to 65% required

• Applicants must provide proof they are fully vaccinated with an FDA approved or authorized vaccine for COVID-19or have a valid medical or religious exemption.

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.

The anticipated base pay range for this position is :

$89,000- $143,000

Additional Description for Pay Transparency:

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.