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 milest... more details
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.
Job Abstracts is an independent Job Search Engine. Job Abstracts is not an agent or representative and is not endorsed, sponsored or affiliated with any employer. Job Abstracts uses proprietary technology to keep the availability and accuracy of its job listings and their details. All trademarks, service marks, logos, domain names, and job descriptions are the property of their respective holder. Job Abstracts does not have its members apply for a job on the jobabstracts.com website. Additionally, Job Abstracts may provide a list of third-party job listings that may not be affiliated with any employer. Please make sure you understand and agree to the website's Terms & Conditions and Privacy Policies you are applying on as they may differ from ours and are not in our control.
Welcome to Job Abstracts
We would like to take a second to Welcome You to Job Abstracts, the nation’s largest Pure Job Board. With over 3.1 million job listings from 15,000+ Companies & Organizations, we help job searchers find careers that match their interests. As an anonymous user, you have probably discovered how easy our system is to use. However, you have just scratched the surface of what we can offer.
We encourage you to Register so you can use our most powerful features: searching with multiple terms, setting up multiple locations, establishing favorite companies, and accessing your search history. If you find a job you like, you can apply directly for it, and then, keep notes on it. We will also keep a lookout for jobs that match your search terms and email you when we find something you may like.
You can register for free and the system is free to use. If you like our system so far, click on Register and unlock the power required by serious job searchers.
Any time you conduct a search, the system shows you job matches, ranked by their Relevance Score (RS).
The score is calculated by a proprietary algorithm that uses Intelligent Machine Learning.
The Relevance Score tells you how well the job opportunity matches your search term or terms.
When not logged in, the system is limited to one search term. Scores for single term matches are usually lower.
When you register, log in, and set up multiple terms prioritized by importance, the jobs found for you will receive a much higher Relevance Score.