Kelly Science, Engineering, Technology & Telecom · 11 hours ago
Clinical Research Specialist
San Francisco Bay Area
Full-time
Hybrid
Mid, Senior Level
$100K/yr - $130K/yr
3+ years expKelly Science & Clinical Functional Service Provider is seeking a Senior Clinical Research Specialist for a long-term position with a Global Medical Device client. The role involves supporting clinical trials within the Clinical R&D Department and ensuring compliance with study timelines and milestones.
Staffing & Recruiting
Hiring Manager
Jacalyn D.
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
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
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
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
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
Preferred
Medical device experience is strongly 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
Holiday
Vacation
Sick/personal time
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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