Associate 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 direct supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

- Serves as an Associate 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;
- Supports the clinical study team 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;
- Coordinates and executes ordering, tracking, and accountability of investigational devices and trial materials;
- May interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel;
- Assists the clinical study team in overseeing the development and execution of Investigator agreements and trial payments;
- Assists in clinical data review to prepare data for statistical analyses and publications;
- If applicable, as part of a clinical trial, may assist in providing on-site procedural protocol compliance and data collection support to the clinical trial sites;
- May also be responsible for processing, tracking, and filing of study documents, and management of the Trial Master File within the clinical projects.
- May support Clinical Research Associate (CRA) activities
- Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;
**Functional and Technical Competencies**:

- Basic understanding of clinical research science and processes, clinical trends, and global clinical trial regulations;
- Experience supporting clinical projects within clinical/ surgical research setting, on time, and in compliance to SOPs and regulations;
- Written and oral English communication 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 6 months of relevant experience preferred.
- Previous experience in clinical research or equivalent is desired.
- Clinical/medical background is a plus.
- Experience in Class III Medical device experience is preferred

**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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