Clinical Research Coordinator at DaVinci Research Roseville, CA
Behavioral Health Market Context
Apply Nowvia Dena Haffner Physiotherapy
Qualifications
- •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
- •Work Environment & Physical Requirements
- •Clinical and office environment
- •Occasional evening or weekend hours depending on study requirements
- •5 more items(s)
Responsibilities
- •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
- •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
- •Follow SOPs and participate in quality improvement activities
- •Assist with protocol training and site initiation activities
- •Support internal and external audits and inspections
- •May require standing, walking, and lifting up to 25 lbs
- •26 more items(s)
More Jobs
- Behavioral Health Clinician - IOP, LCSW, LPCat Texas Children's Hospital
- Behavior Technician — Start a Rewarding ABA Careerat ABA Pathways, LLC
- Direct Support Professional (Bachelors Degree Required)at Action Behavior Centers
- Mental Health Therapist (In-Office or Online)at Therapymatch Inc. (DBA Headway)
- ABA - Behavior Technician - Gravesendat Lighthouse CH
- Associate Onsite Therapist (Work with Students!)at Daybreak Health
- Impactful RBT/Behavior Technician — ABA Therapy Kidsat Apara Autism Centers
- Clinical Research Coordinator Iat Tidewater Physicians Multispecialty Group P C
- Clinical Research Associate I - Community and Behavioral Healthat CEDARS-SINAI
- Assistant Clinical Research Coordinator - Hematology/Oncology (Santa Monica)at UCLA