Senior Clinical Research Coordinator

Senior Clinical Research Coordinator Oxnard, CA

HealthCare Support is actively seeking a Senior Clinical Research Coordinator to fill a job opening. This role’s location is in Chicago, IL (this role may periodically require travel to a secondary site to provide support or temporary coverage as needed).

Daily Responsibilities for Senior Clinical Research Coordinator :

Manages and oversees the day-to-day operations in the administration of clinical trial activities at the site-level (i.

e., direct interactions with study participants)

• Regularly interfaces with current and potential clinical trial participants to determine eligibility and consent of study participants in alignment with clinical trial protocol
• Creates standard operating procedures (SOPs) that adhere to all Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations
• Contributes to the training of clinical trial staff and accountable for compliance with the operational requirements of the clinical trial
• Function as participants’ primary point of contact, keeping them informed on the study progress, and facilitate involvement of other study team members, as needed (e.

g., notify Principal Investigator of safety events)

• Manage participant visit scheduling and technical troubleshooting, escalating issues to the appropriate individual(s)
• Solicit and record information regarding safety events and preparing safety event documentation for review by the Principal Investigator
• Provides accurate and timely data collection, documentation, entry, and reporting in both Sponsor and Walgreens databases
• Supports the regulatory staff in the maintenance of regulatory documents in accordance with Walgreens SOPs and applicable regulations
• Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants
• Maintain regular contact with the Principal Investigator and team to review study details (e.g., progress, adverse events, enrollment)
• Maintain study supplies and issue appropriate participant stipends
• Ensures appropriate credentialing and training of the study team
• Facilitate meetings with the study monitors, auditors, and investigators
• Ensure timely response to queries and documentation of study-related issues
• If applicable, disburses investigational product, manages inventory of equipment and study supplies, and provides patient education regarding administration, as necessary
• Contribute to the development and implementation of tools, processes and training to enhance the administration and execution of clinical studies (e.g., GCP, ALCOA-C)
• Accountable for site compliance with subject safety reporting, escalate issues
• Demonstrate professionalism and apply basic leadership practices in all aspects of the role
• Train and support study team members on a range of communication and teamwork best practices
• Performs other duties related to the clinical trials as delegated by the Principal Investigator
• The shifts for the position will be Monday to Friday, 8am to 5pm
• This is a one-year contract role, with a potential for perm placement afterwards

Required Qualifications for Senior Clinical Research Coordinator :

• High School Diploma / GED
• 3+ years in clinical trial space
• Working knowledge of ICH-GCP, US CFR, and HIPAA regulations
• Experience working independently and making appropriate decisions to operationalize and move clinical trials forward
• Experience overseeing multiple clinical trials concurrently, while maintaining attention to detail
• Experience prioritizing tasks and resources, meeting deadlines, and being adaptable to changing priorities
• Proficient with phlebotomy (certification not mandatory). CRCs are expected to draw blood

Benefits for Senior Clinical Research Coordinator :

• Immediate enrollment in Health Insurance
• Dental Insurance
• Life Insurance
• Employee Assistance Program (EAP)
• Access to Investment Accounts
• Career and educational tools within our Ingenovis ACT (Advocacy) Program

Pay : $48 to $55 an hour