Senior Clinical Research Coordinator

2 weeks ago

New York, New York, United States Aquent Full time
Job Title: Senior Clinical Research Coordinator

Job Summary:

We are seeking a highly skilled and experienced Senior Clinical Research Coordinator to join our team at Aquent Talent. As a Senior Clinical Research Coordinator, you will be responsible for managing and overseeing the day-to-day operations of clinical trials, recruiting and screening study participants, and documenting and reporting on the daily operations of assigned trials.

Key Responsibilities:
  • Manage and oversee the day-to-day operations in the administration of clinical trial activities at the site-level.
  • Regularly interface with current and potential clinical trial participants to determine eligibility and consent of study participants in alignment with clinical trial protocol.
  • Create standard operating procedures (SOPs) that adhere to all Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations.
  • Contribute to the training of clinical trial staff and be 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.
  • 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.
  • Provide accurate and timely data collection, documentation, entry, and reporting in both Sponsor and Walgreens databases.
  • Support the regulatory staff in the maintenance of regulatory documents in accordance with Walgreens SOPs and applicable regulations.
  • Communicate and collaborate 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.
  • Maintain study supplies and issue appropriate participant stipends.
  • Ensure 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.
  • Contribute to the development and implementation of tools, processes, and training to enhance the administration and execution of clinical studies.
  • 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.

Requirements:

  • 3-5 years of experience in clinical trial space.
  • Proficiency in ICH-GCP, US CFR, and HIPAA regulations.
  • Demonstrated ability to work independently, make informed decisions, and drive clinical trials forward.
  • Track record of managing multiple clinical trials simultaneously with meticulous attention to detail.
  • Strong prioritization skills, adept at meeting deadlines, and flexible in adapting to shifting priorities.
  • Proficiency in phlebotomy (certification not mandatory).

Additional benefits offered may include; medical health insurance and dental insurance, life insurance, and eligibility to participate in 401k plan with company match.

About Aquent Talent:

Aquent Talent connects the best talent in marketing, creative, and design with the world's biggest brands.

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