Lead Clinical Research Associate (LCRA)

Axsome Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City. 

About This Role

 Axsome Therapeutics is seeking a Lead Clinical Research Associate (LCRA). The LCRA is responsible for providing direction and leadership to the study Clinical Research Associate team(s). The LCRA will provide daily study management of internal and/or contract CRAs and coordinate and manage clinical monitoring activities from study/site start up to study/ site closeout. This role will need to effectively manage multiple clinical studies/sites to ensure accurate and timely initiation, enrollment, conduct and completion for assigned clinical trials while providing moderate level study management support. The LCRA ensures adequate study monitoring resources are in place for the study. They will also identify quality issues related to clinical monitoring activities and establish action plans along with the study team to address them. 

Job Responsibilities and Duties include, but are not limited to, the following

• Ensure that clinical monitoring activities of their study CRA team(s) are performed in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices (GCP), Key Performance Indicators (KPs), and study-specific requirements. 
• Develop/Revise and/or provide input in the development of clinical trial related documents including but not limited to: study tools, monitoring tools, presentations, meeting materials, case report forms, informed consents, timelines, clinical monitoring plans, site reference manuals, pharmacy manuals, laboratory manuals, protocols, and training materials. 
• Perform qualification, initiation, interim and close out visits and provide visit reports as per monitoring guidelines, as needed. 
• Review of clinical monitoring reports to ensure timely completion/finalization and identification of issues. 
• Responsible for entering study data metrics into the Oversight tracker and participate in the Study Oversight meeting with the Study team. 
• Support and/or interface with external vendors and clinical site personnel, as needed. 
• Responsible for the oversight of the study CRA Team(s) training. 
• Lead/ conduct/ document meeting agendas and minutes for study CRA Team meetings. 
• Provide leadership, protocol, and monitoring support including co – monitoring and visit coverage for CRAs allocated to assigned clinical studies, including resolution of team member conflict and communication issues, with support from Study Managers and others, as needed. 
• Oversee the study specific performance of the CRA team(s) and implements plans of action as needed. Escalate performance issues to the Manager, Clinical Monitoring / Sr. Director of Clinical Monitoring. 
• Responsible for compiling and analyzing data to ensure adequate oversight of the clinical monitoring personnel. 
• Review, track, and report study specific clinical monitoring metrics per established KPIs with Manager, Clinical Monitoring / Sr.Director, Clinical Monitoring, Clinical Study Team(s) and clinical monitoring personnel. 
• Completes the Clinical Monitoring Summary Report (CMSR)and presents the CMSR data to the study team on a defined frequency. 
• Conduct Site Assessment Visits (SAV) with CRAs and completes thorough assessment reports per SOPs. 
• Assist with assessing and interviewing potential clinical monitoring candidates and making hiring recommendations and/or decisions on new staff. 
• Review and approve time sheets and expense reports. 
• Assist Manager, Clinical Monitoring / Sr. Director, Clinical Monitoring with conducting Department Team Meetings. 
• Collaborate with Manager, Clinical Monitoring / Sr. Director, Clinical Monitoring to develop and administer an effective orientation/on-boarding process for new CRA staff. 
• Assist Clinical Operations Management with review and revision of departmental SOPs and policies. 
• Assist Manager, Clinical Monitoring /Sr. Director, Clinical Monitoring to create and deliver new department initiatives, improvement plans or training 
• Assist Manager, Clinical Monitoring /Sr. Director, Clinical Monitoring with development of strategic departmental goals which correlate with corporate goals and formalize departmental action plans to meet those goals. 
• Support the training and development of clinical monitoring personnel. 
• May serve as CRA for projects as directed. 
• Perform other work-related duties as assigned and under the direction of the Sr. Director, Clinical Monitoring.