Johnson & Johnson MedTech · 2 hours ago
Senior Clinical Research Specialist - JJMT Electrophysiology
Irvine, CA
Full-time
Onsite
Mid, Senior Level
$109K/yr - $175K/yr
3+ years expJohnson & Johnson MedTech is a leader in healthcare innovation, focused on developing smarter and less invasive treatments. The Senior Clinical Research Specialist will support clinical trials, ensuring compliance with regulatory standards and fostering strong relationships across the organization.
Hospital & Health Care
Responsibilities
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.g. site management)
Contribute towards development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports), ensure registration on www.clinicaltrials.gov 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
Qualification
Required
Minimum of a Bachelor's Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required
BS with at least 4 years, MS with at least 3 years, PhD with at least 2 years of relevant experience required
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
Up to 20% travel is required
Preferred
Previous medical device Clinical Research experience in the area of interventional cardiology or electrophysiology is strongly preferred
Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV)
Clinical/medical background a plus
Clinical Data Management
Clinical Evaluations
Coaching
Critical Thinking
Data Savvy
Drug Discovery Development
Ethical and Participant Safety Considerations
Good Clinical Practice (GCP)
Industry Analysis
Medicines and Device Development and Regulation
Regulatory Affairs Management
Relationship Building
Research Documents
Safety-Oriented
Scientific Research
Standard Scientific Processes and Procedures
Technologically Savvy
Benefits
Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k))
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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