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Associate Clinical Research Specialist
Irvine, CA, US
Scientific
Bachelors Degree
Full Time, Temporary
Experienced (Non-Manager)
On-site
Biotechnology/Pharmaceuticals
First Shift (Day)
Irvine, CA, US
Experienced (Non-Manager)
Full Time, Temporary
Biotechnology/Pharmaceuticals
On-site
Scientific
Bachelors Degree
First Shift (Day)
Job details
Associate Clinical Research Specialist
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.
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, for 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
• 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 act as Clinical Safety Coordinator (See ANNEX I – Clinical Safety Coordinator Duties and Responsibilities)
• 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
Experience & Education:
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.
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