Clinical Research SpecialistW
Description
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
Under direct supervision, this Associate 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;
- May 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 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;
- 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
Education
Minimum of a Bachelor's Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.
Experience
BS with at least 2 years
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. Remote option is available for right candidate based in United States.
- Ability to travel approximately 10-20% depending on the phase of the program.
- Domestic travel may be occasionally required for training purposes (
Starting At : 0.0
Up To : 0.0
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