Kelly Science, Engineering, Technology & Telecom · 8 hours ago
Senior Clinical Research Specialist
San Francisco, CA
Full-time
Hybrid
Mid, Senior Level
$100K/yr - $130K/yr
3+ years expKelly Science & Clinical is seeking a Senior Clinical Research Specialist for a long-term position with a Global Medical Device client. The role involves supporting clinical trials, ensuring compliance with regulations, and fostering relationships across the organization.
Staffing & Recruiting
Responsibilities
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
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
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
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
Qualification
Required
Bachelor's Degree preferably in Life Science, Physical Science, Nursing, or Biological Science
3+ years of relevant experience in clinical research
Medical device experience is strongly preferred
Ability to travel approximately 40% depending on the phase of the program
Preferred
Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV)
Benefits
Medical
Dental
Vision
401K
Paid time off, including holiday, vacation, and sick/personal time
Voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability
Retirement savings plan
Service bonus and holiday pay plans (earn up to eight paid holidays per benefit year)
Transit spending account
Paid sick leave under the applicable state or local plan
Company
Kelly Science, Engineering, Technology & Telecom
Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Linda Stuit
Senior Vice President, Engineering Specialty
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