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Sr. Clinical Research Coordinator

3 months ago

New York, New York, United States Insight Global Full time

Senior Clinical Research Coordinator Opportunity

This exciting opportunity involves being a key player in clinical trials conducted at a local pharmacy to bring cutting-edge treatments to the community.

About the Company:

We are dedicated to fostering diverse and inclusive workplaces where individuals can fully express themselves every day.

As an employer, we are committed to equal opportunities and affirmative action, valuing each person's unique identity.

If you require support or accommodations due to a disability during the application process, please make a request.

Responsibilities:

  • Manage day-to-day clinical trial operations with participants
  • Interact with participants to determine eligibility and consent
  • Create SOPs complying with FDA and OHRP regulations
  • Train staff and ensure compliance with trial requirements
  • Act as the main contact for participants, keeping them informed
  • Handle participant scheduling, troubleshoot issues, and document safety events
  • Collect and report data accurately in databases
  • Support regulatory staff in maintaining documents
  • Communicate study requirements to the team and stakeholders
  • Maintain contact with the Principal Investigator and team on study progress
  • Manage study supplies and participant stipends
  • Facilitate meetings with monitors, auditors, and investigators
  • Ensure timely responses to study-related matters
  • Contribute to improving tools and processes for clinical studies
  • Ensure site compliance with safety reporting
  • Demonstrate professionalism and leadership in all aspects of the role
  • Train and support team members in communication and teamwork
  • Perform other duties delegated by the Principal Investigator

Required Skills & Experience:

  • Onsite presence required 100% of the time
  • Minimum 35 years of experience as a Clinical Research Coordinator
  • Experience with decentralized/hybrid clinical trials
  • Overseeing multiple trials with attention to detail
  • Experience in diabetes, obesity, and weight loss management trials
  • Knowledge of ICH-GCP, US CFR, and HIPAA regulations

Nice to Have Skills & Experience:

  • Phlebotomy certification (preferred)

Benefits:

Benefit packages start on the 31st day of employment, including medical, dental, and vision insurance, HSA, FSA, DCFSA accounts, and 401k with employer matching.

Employees also receive paid sick leave and other time-off benefits as per the law.