Clinical Research Associate II - 2406181956W

**Description**

Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Clinical Research Associate II. Remote work options may be considered on a case-by-case basis and if approved by the Company.

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/.

Reporting to the Manager, Clinical Research Associates, 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 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.

**Key Responsibilities:**

+ Perform study start-up activities including ICF review, create study-specific essential document lists, manage and communicate the status of study progress and activities

+ Identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge; 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, find opportunities and propose solutions to improve efficiencies within and across related functional areas

+ Partner with cross-functional teams (e.g., clinical data management, medical teams) to assist with query management, data reviews, and task 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 issues and ensure that all clinical aspects of studies are being carried out in accordance with study requirements

+ Assess all data documentation, reports, records, transcripts, exam results, etc. for consistency with case report forms as well as monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices), PHI (Personal Health Information) and regulatory requirements.

+ Maintain oversight of and provide insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality); communicate findings to principal investigators and site staff as well as study sponsor management and leadership staff

+ Maintain appropriate regulatory documentation both internally and externally by ensuring site has the required regulatory documents to conduct the trial/study and that source documentation is properly recorded.

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

+ Develop and deliver trainings on GCPs, protocols, amendments, database, compliance, device accountability, adverse event reporting, regulatory documentation requirements

+ Train and proctor new employees on trial and study-related activities

+ Contribute to the development of clinical protocols, informed consent forms, and case report forms, as requested.

+ Edit/amend informed consent documents

**Qualifications**

**Education:**

+ Bachelor's Degree in a related Science field

**Required:**

+ 3 years of field monitoring experience

+ Experience working in medical device industry

+ Excellent written and verbal communication, presentation, interpersonal, and analytical skills

+ Proven problem-solving and critical thinking skills

+ Demonstrated expertise in MS Office Suite, including Word, Excel, Adobe

+ Ability to travel up to 65%

**Preferred:**

+ Clinical research certification (ACRP or SoCRA, Clinical Coordinator/CRA certification)

**This job posting is anticipated to close on 4.18.2024. The Company may however extend this time-period, in which case the posting will remain available on** **https://www.careers.jnj.com** **to accept additional applications.**

For U.S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $88,000 to $123,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long-term incentive, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below. For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

**Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.**

**Primary Location** NA-US-4887-Danvers

**Other Locations** NA-United States

**Organization** ABIOMED Inc.(6942)

**Job Function** Clinical Trial Project Management

**Req ID:** 2406181956W