Clinical Research Associate

Responsible for pre-clinical trial set up, initial and ongoing regulatory submission and IRB activities, subject screening and enrollment, specimen collection and transmittal, data collection and management, adverse event management to ensure protocol compliance in conjunction with the PI, clinical team and clinical research nurses and team.

• Assist in new IRB application and annual renewal process of COG, sponsored, local and other multi-institutional protocols.
• Screen and enroll patients onto clinical trials in collaboration with clinical team, ensure protocol compliance; coordination of specimen collection and transmittal in collaboration with clinical team.
• Ensure compliance with the Good Clinical Practice guidelines in clinical research.
• Monitor study patients for adverse events in collaboration with clinical team and report as required.
• Enter data on Hematology, Oncology and Stem Cell Transplant patients on electronic data capture forms; prepare for routine data audits and maintain source documents and regulatory binders. Manage communications- mail, phone, fax, e-mail for COG, sponsored, local and multi-institutional studies. Act as liaison between NYMC and Westchester Medical Center, regarding new study requirements.

requirement: BS

Other skills/requirements: Must have a keen attention to detail, be able to multi-task and prioritize assignments.