Senior Clinical Research Specialist

Kelly Science and Clinical FSP is currently seeking a Sr. Clinical Research Specialist for a long-term engagement in Irvine, CA for 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 Senior 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 Procedures And Guidelines, This Position

• Serve as a Senior Clinical Research Specialist within the Clinical R&D Department to support
  
  

execution of company sponsored clinical trials, ensuring compliance with timelines and study

milestones, for the ;

• Oversight/execution of 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;

• May serve as the primary contact for clinical trial sites (e.g. site management);
• Contribute towards development of clinical trial documents (e.g. study protocol, informed
  
  

consents, CRF, monitoring plan, study manual, investigator brochure, annual reports,….),

ensure registration on www.clinicaltrials.gov from study initiation through posting of results and

support publications as needed;

• Management/oversight of ordering, tracking, and accountability of investigational products and
  
  

trial materials;

• Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company
  
  

personnel;

• Oversee the development and execution of Investigator agreements and trial payments;
• Responsible for clinical data review to prepare data for statistical analyses and publications;
• If applicable, may perform monitoring activities including site qualification visits, site initiation
  
  

visits, interim monitoring visits or close out visits based on study need;

• May contribute to the development and delivery of appropriate global evidence generation
  
  

strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects;

• If applicable, as part of a clinical trial, may provide on-site procedural protocol compliance and
  
  

data collection support to the center;

• Contribute to the critical assessment of the literature and to the interpretations and
  
  

disseminations of all evidence generated;

• Contribute to delivery of assigned clinical projects, through effective partnership with the study
  
  

core team leading to delivery of clinical project commitments (deliver on time, within budget and

in compliance with regulations and SOPs);

• 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;

• Support project/study budget activities as assigned;
• Develop a strong understanding of the pipeline, product portfolio and business needs;
• Responsible for ensuring personal and company compliance with all Federal, State, local and
  
  

company regulations, policies and procedures;

• Perform other duties assigned as needed;
• Generally manages work with supervision, dependent on project complexity. Independent
  
  

decision-making for simple and more advanced situations but required guidance for complex

situations.

Experience And Education

• Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.
  
  

Experience

• BS with at least 2-4 years, MS with at least 3 years, PhD with at least 2 years of relevant experience
  
  

preferred.

• Previous experience in clinical research or equivalent is required.
• Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).
• Clinical/medical background a plus.
• Medical device experience highly preferred.
  
  

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 delivery of clinical projects within clinical/ surgical research
  
  

setting, on time, within budget and in compliance to SOPs and regulations;

• Good presentation and technical writing skills;
• Good written and oral communication skills;
  
  

Leadership Competencies

Ability to lead small study teams to deliver critical milestones, as may be assigned.

Leadership Required In Alignment With Leadership Imperatives

• Connect - Develop collaborative relationships with key internal and external stakeholders.
• Shape - Make recommendations for and 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. Mid-Senior level Full-time

• Deliver - Strive to ensure all deliverables on allocated studies are met on time, within budget
• Seniority Level
• Industry
• Medical Equipment Manufacturing
• Biotechnology Research
• Employment Type
• Job Functions
• Science
• Skills
• Research Skills
• Clinical Trials
• Standard Operating Procedure (SOP)
• Clinical Research
• Leadership
• Presentations
• Literature
• Good Clinical Practice (GCP)
  

Posted By: John Burgess