Associate Clinical Research Specialist (Irvine)

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 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.

Associate Clinical Research Specialist

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:

• 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 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;

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.