Description
Clinical Research SpecialistW
**Description**
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
Mentor part of Johnson & Johnson Medtech is recruiting for a Clinical Research Specialist , located in Irvine, CA or remote possibility for a right candidate anywhere in United States.
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.
Under direct supervision, this Clinical Research Specialist will be responsible for supporting one or several clinical trials and projects within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
**POSITION DUTIES & 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:
+ Serves as a 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 Mentor under supervision;
+ Participates in the 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;
+ Serve as the primary contact for clinical trial sites (e. g. site management);
+ Assists in the 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. ) from study initiation through posting of results and support publications as needed;
+ Coordinates and executes ordering, tracking, and accountability of investigational devices and trial materials;
+ Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel;
+ Interfaces and collaborates with Clinical Research Associates (CRAs);
+ Assists in overseeing and supports the development and execution of Investigator agreements and trial payments;
+ Assists in clinical data review to prepare data for statistical analyses and publications;
+ May perform co-monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;
+ May provide on-site procedural protocol compliance and data collection support to the clinical trial sites;
+ Assists in tracking assigned project budgets at a site level
+ Should develop a strong understanding of the pipeline, product portfolio and business needs;
+ Generally manages work with supervision. Independent decision-making for simple situations but requires guidance for complex situations.
**Functional and Technical Competencies:**
+ Good understanding of clinical research science and processes, clinical trends, and global clinical trial regulations;
+ Proven track record in supporting clinical projects within clinical/ surgical research setting, on time, and in compliance to SOPs and regulations;
+ Presentation and technical writing skills;
**Qualifications**
+ Minimum of a Bachelor's Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.
**Experience**
+ BS with at least 3 years of industry experience
+ 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.
**LOCATION & TRAVEL REQUIREMENTS**
* Primary location for this position is Hybrid - Flex at Irvine, California is highly preferred. Remote possibility for a right candidate
* Ability to travel approximately 10-20% depending on the phase of the program.
* Domestic travel may be occasionally required for training purposes (
This job posting is anticipated to close on 9/27/2024. The Company may however extend this time-period, in which case the posting will remain available on to accept additional applications.
The anticipated base salary for this position is $70000 to 112700. California Bay Area - The anticipated base pay range for this position is 81000 to 129605.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit .
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
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