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.

Requirements / Qualifications

• Minimum of 6 years of Clinical Research experience in a pharmaceutical, biotechnology, CRO industry, including a minimum of 3 years of clinical monitoring
• BA/BS or equivalent degree in a scientific discipline or related healthcare field
• Knowledge of Clinical Research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines, required
• Experience in CNS preferred
• Willingness to travel up to 60%

Experience and Knowledge

• Excellent leadership, judgement, and problem-solving skills
• Strong organizational, communication, time management and multi-tasking skills
• Demonstrates core understanding of medical terminology and/or clinical trial activities
• Ability to work on complex or multiple projects and exercise critical thinking with minimal supervision
• Solid interpersonal skills and communication skills (both written and oral)
• Excellent team player, willingness and ability to fill functional gaps in a small but growing organization
• Ability to establish priorities, excellent sense of urgency and desire to collaborate (interpersonal, relationship management) with the study team, cross functional team members and external partners/vendors
• Self-motivated and adaptable to a dynamic environment
• Computer skills including proficiency in the use of Microsoft Office, CTMS, eTMF and eCRF platforms and organization tools.
• Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities

Salary & Benefits

The anticipated salary range for this role is $150,000 - $170,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.

Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.

Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.