Associate Clinical Research Specialist
Vita Global Sciences, a Kelly Company, Irvine, CA, United States
Kelly Science and Clinical FSP is currently seeking a Associate Clinical Research Specialist for a long‑term engagement in Irvine, CA. 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 offers full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401(k), and a variety of other benefits. You may also be eligible for paid time off, including holiday, vacation and sick/personal time.
Job Summary
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.
Duties and Responsibilities
Serve 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
Support 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
Support the clinical study team in the development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports) and applicable trial registration on www.clinicaltrials.gov from study initiation through posting of results and support publications as needed
Coordinate and execute ordering, tracking and accountability of investigational devices and trial materials
May interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel
Assist the clinical study team in overseeing the development and execution of Investigator agreements and trial payments
Assist in clinical data review to prepare data for statistical analyses and publicationsAs 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
May perform other duties assigned as needed
Communicate 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
Ensure personal and company compliance with all Federal, State, local and company regulations, policies and procedures
Education
Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required
Experience
BS, MS or PhD with at least 1 year of relevant experience preferred
Previous experience in clinical research or equivalent is desired
Clinical/medical background is a plus
Medical device experience is a plus
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
Leadership Competencies
Connect – Develop collaborative relationships with key internal and external stakeholders
Shape – Participate in departmental process improvement activities
Lead – Take ownership in critical scientific thinking and development of self and engage in transparent and constructive conversations
Deliver – Strive to ensure all deliverables on allocated studies are met on time and in compliance to SOPs and regulations
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Job Summary
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.
Duties and Responsibilities
Serve 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
Support 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
Support the clinical study team in the development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports) and applicable trial registration on www.clinicaltrials.gov from study initiation through posting of results and support publications as needed
Coordinate and execute ordering, tracking and accountability of investigational devices and trial materials
May interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel
Assist the clinical study team in overseeing the development and execution of Investigator agreements and trial payments
Assist in clinical data review to prepare data for statistical analyses and publicationsAs 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
May perform other duties assigned as needed
Communicate 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
Ensure personal and company compliance with all Federal, State, local and company regulations, policies and procedures
Education
Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required
Experience
BS, MS or PhD with at least 1 year of relevant experience preferred
Previous experience in clinical research or equivalent is desired
Clinical/medical background is a plus
Medical device experience is a plus
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
Leadership Competencies
Connect – Develop collaborative relationships with key internal and external stakeholders
Shape – Participate in departmental process improvement activities
Lead – Take ownership in critical scientific thinking and development of self and engage in transparent and constructive conversations
Deliver – Strive to ensure all deliverables on allocated studies are met on time and in compliance to SOPs and regulations
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