Associate Clinical Research Specialist

Overview

Kelly Science and Clinical FSP is currently seeking an Associate Clinical Research Specialist for a long-term engagement in Irvine, CA with one of our Global Pharmaceutical clients. This role is full-time and includes 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.

• 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 (Use the "Apply for this Job" box below). 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

• 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

• 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.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account.

In addition, employees are entitled to…