Sr. Clinical Research Associate

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Reporting to the manager of 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 Clinical Research Associate 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.

Key Responsibilities:

• Study start-up and study conduct activities including drafting ICF study specific template and TMF plan, approving study specific essential documents list, managing, and communicating the status of study progress and activities.

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

• Provide coaching and training to junior employees.

• Lead in the investigation of all discrepancies in study documentation, by applying clinical protocol knowledge and GCP and develop processes to mitigate reoccurrence throughout study phases.

• Lead in assessing current and new processes, identifying opportunities and implementing solutions to improve efficiencies within and across related functional areas.

• 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.

• Prepare materials for steering and investigator meetings.

• 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.

• Develop and deliver technical 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. Act as a mentor to new or junior level employees.

• Provide oversight of and insight 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 Boards, Contract, and Training, developing process improvements.

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

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

• 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.

• Edit/amend informed consent documents.

Qualifications

• Bachelor's Degree in related field with 5 years of previous field monitoring experience required.

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

• Demonstrated problem-solving and critical thinking skills.

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

• 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.

Location: Home Based (Remote, US)

This job posting is anticipated to close on 11/27/2024. The Company may however extend this time-period, in which case the posting will remain available on https://https://www.careers.jnj.com to accept additional applications.

The anticipated base pay range for this position is 104000 to 166750.

For California Bay area-$119,000 - $191,000

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 and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

• Employees may be 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.

• Employees are eligible for the following time off benefits:

• Vacation - up to 120 hours per calendar year

• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year

• Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

• Additional information can be found through the link below. https://https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market."

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit https://www.careers.jnj.com