36 Clinical Research Specialist Jobs in Irvine, CA
Johnson & Johnson is Hiring a Clinical Research Specialist Near Irvine, CA
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. www.clinicaltrials.gov) 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.
- 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;
- Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.
- 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.
This job posting is anticipated to close on 6/22/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
The anticipated base salary for this position is $70,000 to $112,700.
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 www.careers.jnj.com.
Job Summary
Full Time
Pharmaceutical
$78k-102k (estimate)
05/25/2024
07/19/2024
The job skills required for Clinical Research Specialist include Clinical Research, Clinical Trial, SOP, Coordination, Accountability, Collaboration, etc. Having related job skills and expertise will give you an advantage when applying to be a Clinical Research Specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Clinical Research Specialist. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Clinical Research Specialist positions, which can be used as a reference in future career path planning. As a Clinical Research Specialist, it can be promoted into senior positions as a Scientist - Clinical Research that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Clinical Research Specialist. You can explore the career advancement for a Clinical Research Specialist below and select your interested title to get hiring information.
Similar Jobs
Popular Articles
