SENIOR CLINICAL RESEARCH SPECIALIST

Biosense Webster Inc, part of Johnson & Johnson's MedTech, is recruiting for a Senior Clinical Research Specialist, located in Irvine, CA.
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.
nj.
om/.
Overview This Senior Clinical Research Specialist will be responsible for supporting one or several clinical trials within the Clinical R&D Department while encouraging strong, positive relationships with co-workers across the organization.
Key Responsibilities Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position.
Serve as a Senior Clinical Research Specialist within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones, for Biosense Webster; Oversight/execution of feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures; May serve as the primary contact for clinical trial sites (e.
.
site management); Contribute towards development of clinical trial documents (e.
.
study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports), ensure registration on www.
linicaltrials.
ov from study initiation through posting of results and support publications as needed; Management/oversight of ordering, tracking, and accountability of investigational products and trial materials; Collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel; Supervise the development and execution of Investigator agreements and trial payments; Responsible for clinical data review to prepare data for statistical analyses and publications; If applicable, may perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need; May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects; If applicable, as part of a clinical trial, may provide on-site procedural protocol compliance and data collection support to the center; Contribute to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated; Contribute to delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs); 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; Support project/study budget activities as assigned; Develop a strong understanding of the pipeline, product portfolio and business needs; Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures; Perform other duties assigned as needed; Generally manages work with supervision, dependent on project complexity.
Independent decision-making for simple and more advanced situations but required mentorship for complex situations.
Functional and Technical Proficiencies.
Good understanding of clinical research science and processes, clinical trends, and global clinical trial regulations; Proven track record in supporting delivery of clinical projects within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulations; Good presentation and technical writing skills; Good written and oral communication skills; Leadership Competencies.
Ability to lead small study teams to deliver critical achievements, as may be assigned.
Leadership required in alignment with J&J Leadership Imperatives.
Connect - Develop collaborative relationships with key internal and external stakeholders.
Shape - Make recommendations for and actively participate in departmental process improvement activities.
Lead - Take ownership in critical scientific thinking and development of self and engage in clear and constructive conversations.
Deliver - Strive to ensure all deliverables on allocated studies are met on time, within budget and in compliance to SOPs and regulations.
Qualifications Education & Required Skills/Experiences.
Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science with at least (4) of proven experience Preferred Skills & Experience.
Previous medical device Clinical Research experience in the area of interventional cardiology or electrophysiology Relevant industry certifications preferred (i.
., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO , MDR, MEDDEV).
Clinical/medical background MS degree with 3 years of experience or PhD with 2 years of experience Other.
Primary location for this position is Irvine.
At management discretion, the position may be performed remotely.
Ability to travel approximately 25% depending on the phase of the program.
Frequent (several times per month) interaction with physicians and research staff at centers selected for involvement in clinical research as well as those being evaluated.
May have regular interaction with third party vendors supporting clinical studies as applicable per program The anticipated base pay range for this position is [$] to [$].
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, 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.
Eligible for benefits to include medical, dental, vision and time off as well as any others as provided for in the applicable Collective Bargaining Agreement.
For additional general information on company benefits, please go to.
- https://www.
areers.
nj.
om/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.
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