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Kelly Science, Engineering, Technology & Telecom · 8 hours ago

Associate Clinical Research Specialist

Irvine, CA

Full-time

Onsite

Entry Level

1+ years exp

Kelly Science and Clinical FSP is currently seeking an Associate Clinical Research Specialist for a long-term engagement with a Global Pharmaceutical client. This role involves supporting clinical trials and projects within the Clinical R&D Department while ensuring compliance with study milestones and fostering relationships with colleagues.

Staffing & Recruiting

Responsibilities

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

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

Supports 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

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

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

Qualification

Clinical researchClinical trial documentationICH-GCP complianceMedical device experienceStatistical analysis preparationCollaborative relationshipsProcess improvementCritical scientific thinkingWritten communicationOral communication

Required

Minimum of a Bachelor's Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required

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

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

Benefits

Medical

Dental

Vision

401K

Paid time off

Holiday

Vacation

Sick/personal time

Voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability

Retirement savings plan

Service bonus and holiday pay plans (earn up to eight paid holidays per benefit year)

Transit spending account

Paid sick leave under the applicable state or local plan