Clinical Research Coordinator II - Psychiatry

Position Summary This position will assist the Principal Investigator (PI) in the planning, implementation, and coordination of clinical research studies focused on neuropsychiatric and neurodegenerative disorders, including studies involving cognitive and psychiatric assessment, biomarker collection, digital health technologies, and home-based neuromodulation interventions. The Clinical Research Coordinator II will support participant recruitment, study operations, data collection, regulatory compliance, and participant retention across clinic‑based and remote research settings. Principal Investigator: Davide B. Cappon, MS, PhD Job Overview This position will assist the Principal Investigator (PI) in planning and implementing clinical research studies as assigned. Minimum 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. Duties and Responsibilities Responsible for assisting in the recruitment of study participants. Organizes strategies for recruiting study participants, and screening study participants for eligibility on the telephone, in the clinic and other settings as required. Completes follow up with study participants in prescribed settings as required. Completes record abstraction of source documents, conducting required study measurements and completing study Case Report Forms in accordance with best practice methods. Complies with all institutional policies and government regulations pertaining to human subjects’ protections. Responsible for assisting with Institutional Review Board (IRB) requirements for each study including meeting institutional educational requirements, submitting documents for review, adverse event reporting and annual reviews. Performs basic laboratory activities as needed. Maintains patient confidentiality per HIPAA regulations and keeps study information in a safe and secure location. Adheres to FDA Good Clinical Practice Guidelines. Identifies and resolves problems with protocol compliance by notifying investigator and as necessary with the protocol sponsor. Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator. Performs necessary tests as needed and as appropriate to level of training such as EKGs, Walk tests, etc. Organizes and participates in site visits with the study sponsor to review completeness and accuracy of study documentation. Maintains inventory of all study supplies. Assesses potential patients and eligibility for inclusion in a particular protocol based on protocol requirements. Reviews all eligibility and ineligibility criteria in the patient’s record. Verifies information with the physician. Interviews patients to obtain information for eligibility assessment, explain the study, and obtains signature for the informed consent form. Conducts a QC check of completed CRFs prior to submission for data entry. Coordinates resolution of all data queries. Completes data entry as warranted. Maintains regulatory binders, case report forms, source documents, and other study documents. Monitors the occurrence of clinical adverse events, reporting any to the (PI), the study sponsor and Institutional Review Board. Physical Requirements Typical clinical and administrative office setting. Skills & Abilities High degree of organizational talents, data collection and analysis skills. Requires meticulous attention to detail. Excellent computer skills including word processing. Ability to prioritize quickly and appropriately. Excellent communication and interpersonal skills. Systematic record-keeping. Pay Range: $47,924.24 - $59,894.75 #J-18808-Ljbffr Tufts Medical Center, Inc.