Our JJ MedTech Neurovascular clinical team is currently seeking a Senior Clinical Research Specialist. The role is based in Irvine, CA. Remote work options may be considered on a case-by-case basis and if approved by the Company.
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.jnj.com/.
For more than 130 years, diversity, equity inclusion (DEI) has been a part of our cultural fabric at Johnson Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson Johnson, we all belong.
This Senior Clinical Research Specialist will be responsible for supporting multiple clinical trials within the Clinical RD Department while fostering strong, productive relationships with colleagues across the organization.
POSITION 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 RD Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones, for JnJ MedTech Neurovascular
· Generally, manages work with some supervision, dependent on project complexity. Independent decision-making for simple and some more advanced situations, but requires guidance for complex situations
· 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
· Ability to serve as the primary contact for multiple clinical trial sites (e.g., site management)
· Ability to serve as the primary contact and liaison for clinical trial vendor(s), driving and tracking achievement of vendor-related study milestones
· Contribute towards development and drafting of clinical trial documents (e.g., study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual report)
· 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
· Develop strong collaborative relationships with site personnel, IRBs/ECs, contractors/vendors, and company personnel
· Oversee 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
· Demonstrate 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
Our JJ MedTech Neurovascular clinical team is currently seeking a Senior Clinical Research Specialist. The role is based in Irvine, CA. Remote work options may be considered on a case-by-case basis and if approved by the Company.
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.jnj.com/.
For more than 130 years, diversity, equity inclusion (DEI) has been a part of our cultural fabric at Johnson Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson Johnson, we all belong.
This Senior Clinical Research Specialist will be responsible for supporting multiple clinical trials within the Clinical RD Department while fostering strong, productive relationships with colleagues across the organization.
POSITION 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 RD Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones, for JnJ MedTech Neurovascular
· Generally, manages work with some supervision, dependent on project complexity. Independent decision-making for simple and some more advanced situations, but requires guidance for complex situations
· 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
· Ability to serve as the primary contact for multiple clinical trial sites (e.g., site management)
· Ability to serve as the primary contact and liaison for clinical trial vendor(s), driving and tracking achievement of vendor-related study milestones
· Contribute towards development and drafting of clinical trial documents (e.g., study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual report)
· 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
· Develop strong collaborative relationships with site personnel, IRBs/ECs, contractors/vendors, and company personnel
· Oversee 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
· Demonstrate 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
Education:
· Minimum of a Bachelor’s Degree required, preferably in Life Science, Physical Science, Nursing, or Biological Science; Advanced degree preferred
Required:
· BS with at least 4 years, MS with at least 3 years, PhD with at least 2 years of relevant clinical research experience required
· Previous experience in clinical research or equivalent
· 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
· Ability to travel up to approximately 25% depending on the phase of the program
Preferred:
· Medical device experience highly preferred. Neurovascular/stroke experience is a plus
· Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV)
· Experience with both CRO Sponsor side desired
The anticipated base pay range for this position is $89,000 to $130,000. 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.
o Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
o Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
o Employees are eligible for the following time off benefits:
o Vacation – up to 120 hours per calendar year
o Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
o Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market
Education:
· Minimum of a Bachelor’s Degree required, preferably in Life Science, Physical Science, Nursing, or Biological Science; Advanced degree preferred
Required:
· BS with at least 4 years, MS with at least 3 years, PhD with at least 2 years of relevant clinical research experience required
· Previous experience in clinical research or equivalent
· 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
· Ability to travel up to approximately 25% depending on the phase of the program
Preferred:
· Medical device experience highly preferred. Neurovascular/stroke experience is a plus
· Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV)
· Experience with both CRO Sponsor side desired
The anticipated base pay range for this position is $89,000 to $130,000. 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.
o Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
o Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
o Employees are eligible for the following time off benefits:
o Vacation – up to 120 hours per calendar year
o Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
o Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market