Management Consulting Group · 11 hours ago
ISIJP00011670 Clinical Research Associate 3 avail for w2 ref
Sunnyvale, CA, United States
Full-time
Hybrid
Senior Level, Lead/Staff
$92/hr - $92/hr
8+ years expManagement Consulting Group is seeking a Senior Clinical Research Associate to support pre‑market clinical studies of investigational drugs. This role involves contributing to all clinical research activities, collaborating with surgeons and stakeholders, and managing various aspects of clinical trials.
Human ResourcesRecruitingStaffing Agency
Responsibilities
Contributing to all clinical research activities from study start‑up through FDA approval
Tracking study progress and data
Co‑managing site start‑up/activation, preparing study documents and checklists
Assisting with clinical trial agreements and budget negotiation
Supporting development and maintenance of monitoring plans and training materials
Assisting with EDC/eCRFs, CTMS, eTMF, and imaging core lab interfaces
Reviewing IRB submissions, consents, and regulatory documentation
Drafting and amending study documents (ICF, CRFs, protocols, monitoring plans, study tools)
Conducting on‑site and remote qualification, initiation, interim co‑monitoring, and close‑out visits
Performing source data verification
Ensuring data integrity, timely entry, query resolution, and investigational drug accountability
Partnering with CRO data management on data cleaning
Managing eTMF and study documentation, trip reports, site contact documentation, and status reports
Supporting study scoping (pre‑study questionnaires, study design, surgeon/site selection)
Preparing for and supporting site and internal/external audits
Preparing and presenting SIVs and investigator meetings
Qualification
Required
previous hands‑on pharmaceutical drug trial implementation
significant knowledge of clinical/outcomes research study design
advanced knowledge of clinical investigation of investigational drugs
strong working knowledge of GCP/ICH‑GCP and FDA expectations
experience with protocol and ICF development and amendments
experience negotiating clinical research contracts and budgets
proficiency with EDC, CTMS, eTMF
excellent interpersonal and communication skills
ability to work cross‑functionally and manage multiple priorities
ability to travel up to 40%
high attention to detail, organization, and a self‑starter attitude
Proficiency with Microsoft Office and PDF applications
Preferred
Experience with surgical trials
fluorescence imaging experience is a strong plus
knowledge of statistics, statistical methods, and design of experiments
accustomed to hospital environments and working with nurses and surgeons
Company
Management Consulting Group
Management Consulting Group is a staffing company that offers recruiting and managed services.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Todd Ghanizadeh
Chief Executive Officer
Company data provided by crunchbase