Clinical Research Coordinator Job at DaVinci Research, Roseville, CA

NmRNOVhjUkRTYUF3QVhRZnRiUUJlS1lEd2c9PQ==
  • DaVinci Research
  • Roseville, CA

Job Description

Position Summary

The Clinical Research Coordinator (CRC) is responsible for coordinating and managing clinical research studies in compliance with federal regulations, institutional policies, and Good Clinical Practice (GCP). The CRC works closely with the Principal Investigator (PI), sponsors, monitors, and study participants to ensure accurate data collection, subject safety, and protocol adherence.

Essential Duties and Responsibilities

Study Coordination

  • Coordinate day-to-day operations of assigned clinical research studies
  • Ensure study activities comply with study protocols, SOPs, ICH-GCP, FDA, and IRB requirements
  • Serve as liaison between PI, sponsor, CRO, IRB, and study participants
  • Prepare for and participate in sponsor monitoring visits, audits, and inspections

Participant Management

  • Screen, recruit, and enroll study participants according to inclusion/exclusion criteria
  • Conduct informed consent process and ensure proper documentation
  • Schedule and conduct study visits per protocol
  • Monitor participant safety and report adverse events and serious adverse events (SAEs)

Regulatory & Documentation

  • Maintain regulatory binders (e.g., investigator files, essential documents)
  • Prepare and submit IRB applications, amendments, continuing reviews, and reports
  • Ensure timely reporting of protocol deviations, AEs/SAEs, and unanticipated problems
  • Maintain accurate source documentation and case report forms (CRFs/eCRFs)

Data Management

  • Collect, enter, and verify study data in EDC systems
  • Resolve data queries and ensure data accuracy and completeness
  • Maintain confidentiality and data integrity in accordance with HIPAA

Investigational Product (IP) Management

  • Receive, store, dispense, and account for investigational products per protocol
  • Maintain accurate drug/device accountability logs
  • Coordinate with pharmacy or sponsor as needed

Quality & Compliance

  • Follow SOPs and participate in quality improvement activities
  • Assist with protocol training and site initiation activities
  • Support internal and external audits and inspections

Qualifications

Required

  • Bachelor’s degree in life sciences, health sciences,
  • Knowledge of clinical research regulations and GCP
  • Strong organizational, communication, and time-management skills
  • Proficiency with Microsoft Office and EDC systems
  • Ability to manage multiple studies simultaneously

Preferred

  • 1–3 years of clinical research experience
  • CRC certification (ACRP or SOCRA)
  • Experience with IRB submissions and regulatory documentation
  • Phlebotomy, ECG, or vital signs experience (if applicable)

Work Environment & Physical Requirements

  • Clinical and office environment
  • May require standing, walking, and lifting up to 25 lbs
  • Occasional evening or weekend hours depending on study requirements

Job Tags

Work at office, Afternoon shift,

Similar Jobs

London Jewelers

Online Customer Service Representative Job at London Jewelers

 ..., fine timepieces and gifts, presented in a luxurious style and setting with superior customer service. We are seeking a dedicated online customer service, brand relationship representative to manage customer interactions and provide support for our products and services... 

Aequor

Speech Language Pathologist Job at Aequor

Aequor is seeking a dedicated, schoolbased Speech and Language Pathologist to support at one of our partner districts in Brentwood, CA for the 20252026 school year. Position Details Start: ASAP Setting: Onsite only Student Population: Preschool or elementary...

Knauf North America

Production Associate Job at Knauf North America

 ...and creative individuals who thrive in an entrepreneurial, collaborative and ever-changing environment. Pay Rate: $21.75/hr. Shift Premium: Additional $1.00/hr. Perfect Attendance Bonus: Additional $0.75/hr. Up to a 5% quarterly bonus! Our benefits go beyond... 

Fiddleheads Coffee Roasters

Cafe Manager Job at Fiddleheads Coffee Roasters

Fiddleheads Coffee Roasters has an incredible opportunity for a person that is passionate about leadership. We are looking for someone to lead all aspects of one of our cafes, including their team in our mission of astonishing our customers. If you thrive in team leadership...

btyDENTAL

Dental Sterilization Technician Job at btyDENTAL

 ...Sterilization Technician - Start Your Career & Grow With Us! Starting Pay: From $17.00 per hour (with unlimited pay increases) Are you looking for a hands-on career in the dental field with no experience required? btyDENTAL Group, LLC is hiring a Sterilization...