Sr. Clinical Research Specialist - Electrophysiology

Johnson & Johnson Innovative Medicine•Irvine, CA

1d•Remote

About The Position

Our J&J MedTech Electrophysiology clinical team is currently recruiting for a Sr. Clinical Research Specialist. This role is located in Irvine, California. 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/. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech JOB SUMMARY This Senior Clinical Research Specialist will be responsible for supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.

Requirements

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 preferred.
Previous experience in clinical research or equivalent is required.
Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).
Clinical/medical background is a plus.
Medical device experience is highly preferred.
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 English communication skills
Ability to travel approximately 20% depending on the phase of the program.

Responsibilities

Serves 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, Inc
Oversees/executes 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)
Contributes towards development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports,….)
Supports applicable trial registration (e.g. www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed
Manages/oversees ordering, tracking, and accountability of investigational devices and trial materials
Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel
Interfaces, collaborates and oversees Clinical Research Associates (CRAs)
Oversees and supports the development and execution of Investigator agreements and trial payments
Is responsible for 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
May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects
May provide on-site procedural protocol compliance and data collection support to the clinical trial sites
Contributes to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated
Contributes 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)
May assist with the development of e Post-Market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports (ER) within the defined timelines and review/update at planned intervals
May assist with maintaining the overview to assure (study) commitments are timely and properly met by coordination of specific documentation and contribution to cross-functional review of associated documents where relevant
Supports project/study budget activities
May act as Clinical Safety Coordinator (See ANNEX I – Clinical Safety Coordinator Duties and Responsibilities)
Mentors team members
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 manages work with supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but requires guidance for complex situations

Benefits

Subject to the terms of their respective plans, employees are 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.
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