Clinical Research Specialist

3 weeks ago


Irvine, United States Johnson & Johnson Full time

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);
- 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.
- Ability to travel approximately 10-20% depending on the phase of the program.
- Domestic travel may be occasionally required for training purposes (



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