Clinical Research Coordinator II - Psychiatry

Job Description

The Clinical Research Coordinator II will assist the Principal Investigator (PI) in planning, implementing, and coordinating clinical research studies focused on neuropsychiatric and neurodegenerative disorders. Duties include:

• Assisting in the recruitment of study participants.
• Screening study participants for eligibility on the telephone, in the clinic, and other settings as required.
• Completing follow-up with study participants in prescribed settings as required.
• Completing record abstraction of source documents, conducting required study measurements, and completing study Case Report Forms in accordance with best practice methods.
• Complying with all institutional policies and government regulations pertaining to human subjects' protections.
• Supporting Institutional Review Board (IRB) requirements for each study, including meeting institutional educational requirements, submitting documents for review, adverse event reporting, and annual reviews.
• Maintaining patient confidentiality per HIPAA regulations and keeping study information in a safe and secure location.
• Adhering to FDA Good Clinical Practice Guidelines.
• Identifying and resolving problems with protocol compliance by notifying the investigator and as necessary with the protocol sponsor.
• Arranging necessary tests and procedures in accordance with protocol requirements and reporting results to the investigator.
• Performing necessary tests as needed and as appropriate to level of training such as EKGs, Walk tests, etc.
• Organizing and participating in site visits with the study sponsor to review completeness and accuracy of study documentation.
• Maintaining inventory of all study supplies.
• Assessing potential patients and eligibility for inclusion in a particular protocol based on protocol requirements.
• Interviewing patients to obtain information for eligibility assessment, explaining the study, and obtaining signature for the informed consent form.
• Conducting a Quality Control (QC) check of completed CRFs prior to submission for data entry.
• Coordinating resolution of all data queries.
• Completing data entry as warranted.
• Maintaining regulatory binders, case report forms, source documents, and other study documents.
• Monitoring the occurrence of clinical adverse events, reporting any to the PI, the study sponsor, and Institutional Review Board.

Qualifications

• Bachelor’s degree OR High School Diploma or equivalent AND Four (4) years of related experience.
• Basic Life Support (BLS) certification may be required based on specific role requirements.
• Two (2) years in research related activities.
• Preferred Qualifications: Five (5) years in research related activities. Previous experience in clinical trials. IATA Hazardous Good Shipping certification. CITI Human Research Protection certification. 2-5 years experience in research related activities, preferably in psychiatry, neurology, neuroscience, psychology, aging, or related clinical research settings.