Clinical Research Coordinator

Found in: Appcast Linkedin GBL C2 - 2 weeks ago

East Northport, United States Medix™ Full time

Clinical Research Coordinator

  • Clinical Research Coordinator; experience as a CRC is REQUIRED
  • 24 hours per week, M, W & F but open to candidate preference
  • 4 month contract; NO opportunity for extension
  • 100% ON SITE
  • Experience with Phlebotomy & vitals highly preferred


Summary

The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI) on multiple ongoing research studies. While the Principal Investigator is ultimately responsible for the clinical trial, the CRC is responsible for the facilitation and coordination of the daily clinical trial activities and plays a critical role in the conduct of the study. The CRC works collaboratively with the entire site team, Sponsors, and clinical monitors to ensure ICH/GCP compliance, site productivity, and timely completion of studies.


Responsibilities

  • Ensure clinical study compliance with local and federal laws and regulations according to ICH/GCP Guidelines
  • Ensure study feasibility assessments for contracted Sponsor-initiated studies
  • Assist the Clinical/Site Ops leads on the set-up/start-up of research site to prepare for start-up and conduct of clinical trials
  • Lead oversight of pre-study, site initiation, and close-out visits with sponsor or CRO
  • Consult with Site leads, Sponsor, and CRO to determine the best recruitment practices for site and trials
  • Track study activities to ensure compliance with standard operating procedures (SOPs), protocols, and all related local, state, and national regulatory and institutional policies
  • Arrange screening and recruitment of potential study participants by scheduling visits to establish Informed Consent and perform intake assessments according to protocols
  • Create and maintain all essential documents and records related to the study
  • Acts as a point of reference for study participants by answering questions and keeping them informed on the study’s progress
  • Oversee and/or manages the inventory of equipment and supplies related to the study, including documentation, reporting of issues, and ordering clinical supplies as needed
  • Communicate with laboratories and clinical investigators to ensure review and reporting of lab results and other clinical testing results
  • Direct the request, collection, labeling, storage, or shipment of interventional products
  • Ensure collection of specimens, questionnaire information, and input of data and patient information into electronic clinical systems
  • Monitor enrollment status of participants at the site for each specific clinical study
  • Operate as primary contact for Sponsors/CROs to schedule and coordinate site visits and answer queries
  • Participate in meetings (ie., Investigator Meetings, Site Trainings) and seminars to update knowledge of clinical research and related issues
  • Prepare or participate in quality assurance audits and inspections performed by Sponsors/CROs, regulatory authorities, or exclusively designated review groups.
  • Provide regular updates to Site Clinical Investigator(s) and Clinical/Site Ops leads on study progress related to recruitment, compliance, and other study-related matters.

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