Clinical Research Specialist Ii - Laminar, Inc.

Laminar, part of the Johnson & Johnson family of Medical Device companies, is current recruiting for a Clinical Research Specialist II. The preferred location for this role is within the Western half of the United States but remote options anywhere within the US will be considered on a case by case basis.

About Johnson & Johnson

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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/.

This Clinical Research Specialist will be responsible for supporting one or more clinical trials within the Clinical Affairs Department while fostering, productive relationships with colleagues across the organization.

Duties and Responsibilities

• Serves as a Clinical Research Specialist within the Clinical Affairs Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones.

• May Participate in the feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the good clinical practices, applicable legislation and Company Standard Operating Procedures.

• May serve as the primary contact for clinical trial sites (e.g. site management).

• Assists in the development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports).

• Supports trial registration (e.g. www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed.

• May coordinate and complete ordering, tracking, and accountability of investigational devices and trial materials.

• Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel.

• May coordinate the development and execution of Investigator agreements and trial payments.

• Assists in clinical data review to prepare data for statistical analyses and publications.

• May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need.

• Provides on-site (cath lab or electrophysiology lab) procedural protocol compliance and data collection support to the clinical trial sites.

• Assists in tracking assigned project budgets.

• May coordinate safety-related activities of clinical trials.

• May perform other duties assigned as needed.

• Is responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders.

• Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures.

• Should develop a strong understanding of the pipeline, product portfolio and business needs.

• Generally, handles work with supervision. Independent decision-making for simple situations but requires guidance for complex situations.

The base pay range for this position is $90,000 to $130,000 based on experience. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus. 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, 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.

https://www.careers.jnj.com/employee-benefits Job Qualifications:

• Minimum of a Bachelor's degree required; Major in Biological sciences or a health related field preferred .

• Minimum of 3 years of Clinical Research experience in a Sponsor-side Medical Device or Hospital environment required.

• Relevant industry certifications strongly preferred (i.e., CCRA, CCRC, CCRP).

• Clinical/medical background in interventional cardiology is a plus . Medical device experience is a plus .

• Presentation and technical writing skills.

• Critical Thinking and Problem-Solving: Ability to analyze complex medical and scientific information, identify potential issues or risks, and develop practical solutions.

• Communication and Collaboration: Written and verbal communication skills to effectively communicate with cross-functional teams, investigators, and other stakeholders. Collaboration skills to work effectively in multidisciplinary teams.

• Ethical Standards: Commitment to maintaining ethical standards in Clinical Research, including patient privacy, informed consent, and protection of human subjects.

• Continuous Learning: Willingness to stay updated with the latest advancements, regulations, and industry best practices in Clinical Research and medical device technologies.

• Approximately 25% travel to research sites (which may increase depending on the phase of the program), conferences and/or other Laminar affiliated activities.

• There is the potential for exposure to blood borne pathogens and other potentially infectious materials.

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 www.careers.jnj.com .

This job posting is anticipated to close on 4/5/2024. 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.