Cynet Systems · 2 months ago
Senior Clinical Research Associate
Sunnyvale, CA
Full-time
Onsite
Senior Level
$79.93/hr - $89.93/hr
5+ years expCynet Systems is seeking a Senior Clinical Research Associate who will contribute to the start-up, execution, and management of clinical studies from initiation through FDA approval. This role involves collaboration with internal teams, clinical sites, and external partners to ensure study compliance, accuracy, and efficiency in accordance with GCP, ICH, and regulatory standards.
EmploymentRecruitingStaffing Agency
Responsibilities
Contribute to all clinical research activities to ensure successful study start-up and management through FDA approval
Maintain and track clinical study data, monitor site progress, and assist with investigator qualification, training, and patient recruitment
Co-manage site start-up and activation, including preparation of study-related documents, checklists, budgets, and clinical trial agreements
Support eCRFs/EDC systems, CTMS, eTMF, and imaging core labs
Review IRB submissions, consent forms, and regulatory documentation, ensuring timely and successful outcomes
Assist in drafting and amending clinical study documents (protocols, ICFs, CRFs, monitoring plans, study tools, etc.)
Perform or assist in on-site and remote visits including qualification, initiation, interim monitoring, and close-out visits
Conduct co-monitoring to ensure regulatory and protocol compliance and verify source data accuracy
Support clinical trial sites to maintain data integrity, timely data entry, and proper investigational product accountability
Partner with CRO data management teams to facilitate the data cleaning process
Develop and manage study documentation, including eTMF, trip reports, correspondence, and monthly status updates
Assist the Senior Clinical Project Manager with study scoping, site selection, and design activities
Support sites in audit preparation and participate in internal and external audits
Assist in preparation and delivery of Site Initiation Visits (SIVs) and Investigator Meetings
Qualification
Required
Proven experience implementing pharmaceutical trials; experience with surgical trials preferred
Advanced knowledge of clinical investigation processes, investigational drug studies, and ICH/GCP regulations
Strong understanding of clinical research and monitoring requirements
Experience with protocol and informed consent form (ICF) development and amendments
Proficiency in Microsoft Office Suite, PDF tools, and electronic systems (EDC, CTMS, eTMF)
Excellent communication, presentation, and organizational skills
Strong ability to collaborate across functions and work with physicians and external partners
Experience negotiating clinical research contracts and budgets
Ability to manage multiple priorities and adapt to changing requirements
Must be able to travel up to 40%
Bachelor's degree with a minimum of 8 years of related experience, or
Nursing degree or Master's degree with at least 6 years of clinical research experience, or
MD or PhD with a minimum of 5 years of clinical research experience
Preferred
Knowledge of statistics, statistical methods, and experimental design
Experience working in a hospital environment and collaborating with nurses and surgeons
Clinical research or clinical trial management certification preferred
Company
Cynet Systems
Headquartered in Washington DC Metro Area, Cynet Systems is a top talent supplier for companies across North America.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Ashwani (Ash) M.
Partner and Co-CEO
Nikhil "Nick" Budhiraja
Founder / Co-CEO
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