Associate Clinical Research Specialist Job Listing at Kelly Services in Irvine, CA (Job ID 9344876)

Description

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 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 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;

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:
Leadership required in alignment with client Leadership Imperatives:

• 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 earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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