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.
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