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Columbia University, New York, NY, USA

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"Project Coordinator"

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Project Coordinator

Position Summary

Study Coordinator for Alzheimer’s Disease and Related Disorders (ADRD) clinical trials. Alzheimer’s Clinical Trials Consortium (ACTC) Site Liaison.

Responsibilities

  • Study Coordinator: Perform all study related procedures including but not limited to:
  • Conduct and coordinate consortium (ACTC/ADCS) and industry clinical trials in neurodegenerative disease under the direction of the principal investigator
  • Complete and maintain regulatory documentation
  • Initiate and maintain submissions for CUIMC IRB and central IRBs
  • Create and maintain source documents
  • Consent study participants according to CGP guidelines
  • Ensure that GCP and FDA guidelines are followed
  • Complete study-related data entry and chartings in a timely manner
  • Prepare study related correspondence
  • Perform study-related ECGs, vital signs and blood draws as necessary
  • Arrange research-related imaging and other auxiliary research related studies
  • Travel to investigator meetings as needed
  • Ensure participant compliance to study protocol
  • Dispense and account for investigational product and research study samples
  • Arrange study participant reimbursement via the standard CU policies and procedures
  • Work with sponsor and consortium entities to ensure that all required duties are completed
  • Maintain productive working relationship between sponsor/consortium staff, study monitor, site staff and principal investigator
  • Perform neuropsychological and other testing scales and assessments
  • Recruit research participants by phone
  • Explain studies to potential participants by phone and in person
  • Schedule appointments for research participants screening visits and regular study visit
  • ACTC Site Liaison:
  • Travel to investigator meetings
  • Primary point person across all the ACTC projects
  • Clinical trials coordinator for the ACTC projects
  • Attend ACTC Steering Committee Meetings three times a year
  • Participate in monthly ACTC Site Liaison Meetings

Minimum Qualifications

  • Bachelor's degree or equivalent in education and experience.
  • Certifications in CDR, Alzheimer’s Disease Assessment Scale Certification, CANTAB, GDS, MoCA, NPI-Q, ADCS-ADL, MMSE.

Preferred Qualifications

  • >3 years hands-on experience in ADRD research testing.
  • Certifications in CDR, C-SSRS, Alzheimer’s Disease Assessment Scale Certification, RBANS/, CTT, LNS, PF, GDS, MoCA, NTB, CIBIC-Plus and VaDAS, CANTABelect, CGIC, S-STS,CFT, Cogstate battery, NPI, ADCS-ADL, NPI, MMSE, TUG, CFT, LFT, CFT, NACC battery.
  • Spanish fluency.
10

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