Job Description

• 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 Client databases.
• Supports the regulatory staff in the maintenance of regulatory documents in accordance with Client 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.
• Conducting all trial visits.
• Completing all study-specific assessments (e.g. vital signs, EKG, blood collection).
• Processing all samples and shipping to Central Lab.
• Maintaining study source.
• Entering data into sponsor EDC and query resolution As the sole Senior Clinical Research Coordinator (SCRC) on-site, the chosen candidate must be adept at protocol comprehension and be capable of working autonomously.

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