Kelly Science and Clinical FSP is currently seeking a Clinical Research Specialist in
Irvine, CA for a 7 to 8 month contract opportunity. with one of our Global Medical Device 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.
This Clinical Research Specialist will be responsible for supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
DUTIES & RESPONSIBILITIES Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate procedures and guidelines, this position:
- Serves as a Clinical Research Specialist within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones under supervision;
- Participates in the feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-Google Cloud Platform, applicable legislation and Company Standard Operating Procedures;
- May serve as the primary contact for clinical trial sites (e.g. site management);
- Assists in the development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports);
- Supports applicable trial registration (e.g. 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;
- Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel;
- Interfaces and collaborates with Clinical Research Associates (CRAs);
- Assists in overseeing and supports the development and execution of Investigator agreements and trial payments;
- Assists in clinical data review to prepare data for statistical analyses and publications;
- May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;
- May provide on-site procedural protocol compliance and data collection support to the clinical trial sites;
- Assists in tracking assigned project budgets;
- 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;
- Should develop a strong understanding of the pipeline, product portfolio and business needs;
- Generally manages work with supervision. Independent decision-making for simple situations but requires guidance for complex situations.
EXPERIENCE AND EDUCATION Education - Minimum of a Bachelor's Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.
Experience - BS with at least 2 years, MS and PhD with at least 1 year of relevant experience preferred.
- Previous experience in clinical research or equivalent is desired.
- Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, Google Cloud Platform, ISO 14155, MDR, MEDDEV,...).
- Clinical/medical background is a plus.
- Medical device experience is a plus.
- REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS
Functional and Technical Competencies: - Good understanding of clinical research science and processes, clinical trends, and global clinical trial regulations;
- Proven track record in supporting clinical projects within clinical/ surgical research setting, on time, and in compliance to SOPs and regulations;
- Presentation and technical writing skills;
- Written and oral English communication skills.
Leadership Competencies: - Connect - Develop collaborative relationships with key internal and external stakeholders.
- Shape - Actively 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, within budget and in compliance to SOPs and regulations.
LOCATION & TRAVEL REQUIREMENTS - Primary location for this position is Irvine, CA. At management discretion, the position may be performed remotely.
- Ability to travel approximately 20% depending on the phase of the program.
EXTERNAL INTERACTIONS - Frequent (several times per month) interaction with physicians and research staff at centers selected for involvement in clinical research as well as those being evaluated.
- May have regular interaction with third party vendors supporting clinical studies as applicable per clinical trial.
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