Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Clinical Development & Research - Non-MD
Job Category:Scientific/Technology
All Job Posting Locations:Irvine, California, United States of America
Job Description:Our J&J MedTech Electrophysiology clinical team is currently recruiting for a
Clinical Research Leader. This role is located in Irvine, California.
Job Description:- Serve as a Clinical Research Lead to execute and manage 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 the trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures.
- Serves as the main contact for clinical trial sites (e.g. site management).
- Develop clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports) with minimal direction.
- Ensure trial registration from study initiation through posting of results and support publications as needed; (e.g. on www.clinicaltrials.gov)
- Management/oversight of ordering, tracking, and accountability of investigational products and trial materials.
- Communicate and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel.
- Lead all aspects of development and execution of Investigator agreements and trial payments.
- Leads 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.
- If applicable, as part of a clinical study, may provide on-site procedural protocol compliance and data collection support to the center.
- Contribute to the assessment of the literature and to the interpretations and disseminations of all evidence generated.
- Responsible for clinical projects, through partnership with the study core team leading to delivery of clinical project commitments.
- Responsible for communicating business related issues or opportunities to next management level. Function as a trusted resource of accurate, up-to-date project knowledge as requested by key team member.
- Supervise and manage assigned project budgets to ensure adherence to business plans.
- Support clinical scientific discussions with regulatory agencies to drive support of the clinical and regulatory strategy.
- Develop a strong understanding of the pipeline, product portfolio and business needs.
- Serve as the clinical representative on the Product Development team.
- 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 limited supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but requires minimal guidance for complex situations.
- Responsible for communicating business related issues or opportunities to next management level
- Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
- For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- May perform other duties assigned as needed.
Qualifications - Minimum of a bachelor's degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 6 years clinical research experience is required or Masters degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 5 years clinical research experience is required OR PhD in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 3 years clinical research experience is required
- Experience with project/team leadership is required.
- Relevant industry certifications are preferred (examples may include; CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV).
- Medical device experience highly preferred.
- CRO experience and site management and clinical site monitoring are assets.
- Experience delivering presentations and writing clinical reports is preferred.
- This position will require on-site work in Irvine, CA, on average up to 2-3 days weekly, as well as attendance at critical on-site meetings as scheduled.
Required Skills:Preferred Skills:Analytical Reasoning, Clinical Data Management, Clinical Evaluations, Clinical Trial Protocols, Coaching, Consulting, Data Savvy, Drug Discovery Development, Good Clinical Practice (GCP), Medicines and Device Development and Regulation, Persistence and Tenacity, Regulatory Affairs Management, Research Documents, Resource Management, Safety-Oriented, Scientific Research, Technologically Savvy
The anticipated base pay range for this position is :$109,000.00 - $174,800.00
Additional Description for Pay Transparency:
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
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
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
