Clinical Research Specialist

Vita Global Sciences, a Kelly Company; Irvine (CA); Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

401(k)

Job summary

Kelly Science and Clinical FSP is hiring a Clinical Research Specialist for a long-term engagement in Irvine, CA. The role is hybrid and part of our FSP division, a managed solution within Kelly Services.

The position is full-time with comprehensive benefit options. You will support multiple clinical trials in the Clinical R&D Department, coordinate trial setup, data collection, and regulatory documentation, and liaise with sites, IRBs, vendors, and study personnel to ensure compliance with

Qualifications

• Bachelor’s degree in Life Science, Physical Science, Nursing, or Biological Science required.
• BS with 2+ years experience; MS/PhD with 1+ year preferred.
• Certifications such as CCRA/CCRC/CCRP/RAC are preferred.

Responsibilities

• Support execution of company-sponsored clinical trials to meet milestones.
• Coordinate trial setup, data collection, and monitoring visits with sites.
• Assist in developing trial documents and regulatory submissions.
• Interface with IRBs/ECs, vendors, and site personnel.

Skills

Clinical research knowledge

English communication

Presentation skills

Technical writing

Education

Bachelor’s degree (Life Sciences)

MS/PhD preferred

Job description

Kelly Science and Clinical FSP is currently seeking a Clinical Research Specialist for a long‑term engagement in Irvine, CA with one of our Global Medical Device clients. This position is hybrid. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full‑time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

SECTION 1: JOB SUMMARY

This Clinical Research Specialist will be responsible for supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.

SECTION 2: DUTIES & RESPONSIBILITIES

Under General Direction And In Accordance With All Applicable Federal, State And Local Laws/regulations And Corporate, 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, 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
• May perform other duties assigned as needed
• Is responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up‑to‑date project knowledge as requested by key stakeholders
• Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures
• 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.

SECTION 3: EXPERIENCE AND EDUCATION

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, MS and PhD with at least 1 year of relevant experience preferred.
• Previous experience in clinical research or equivalent is desired.
• Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).
• Clinical/medical background is a plus.
• Medical device experience is a plus.

SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

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
• Written and oral English communication skills.

Posted By: Lea Lolley