Clinical Monitoring Associate

Axsome Therapeutics•New York, NY

3d•Hybrid

About The Position

Axsome Therapeutics is seeking a Clinical Monitoring Associate (CMA). Supporting the study Lead Clinical Research Associate (LCRA), the CMA provides administrative and operational support to assist effective site management and oversight of clinical monitoring for assigned protocols. With guidance from the LCRA, the CMA maintains study documentation and tracking tools and supports study activities from start-up through closeout. The CMA also assists with identifying and escalating quality issues related to monitoring activities and partners with the study team to document and implement action plans to address them. This role is based at Axsome’s HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.

Requirements

BA/BS or equivalent degree required, preference for a background in a scientific discipline or related healthcare field.
Minimum of 1 year of clinical research experience in pharmaceutical, biotechnology, CRO industry.
1 year of clinical monitoring and/or Clinical Trial Associate (CTA) experience preferred.
Excellent judgement, and problem-solving skills.
Strong organizational, communication, time management and multi-tasking skills.
Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles.
Demonstrates core understanding of medical terminology and/or clinical trial activities.
Knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines, required.
Experience in CNS preferred.
Ability to work on complex and/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 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 company environment and able to adjust workload based upon changing priorities.
Willingness to travel up to 20%.

Responsibilities

Support the LCRA team, in overseeing clinical monitoring operational execution of assigned clinical studies(s).
Assist the LCRA in compiling and analyzing monitoring metrics and study data, documenting results in the relevant trackers, and verifying monitoring compliance to support adequate oversight of clinical monitoring personnel.
Provide administrative support and tracking, which may include (but is not limited to) the following: Confirm required CRA study training completion documentation. Perform eTMF reconciliation activities (as assigned). Maintain IP and freezer temperature log trackers. File CRA meeting minutes and agendas in the eTMF. Document oversight follow-up (e.g., track reasons for delayed report drafts and revisions). Verify documents listed as collected in Monitoring Visit Reports (MVRs) are filed in the eTMF. Review and maintain study site monitoring visit trackers.
May assist in the development/revision 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.
May review clinical monitoring reports to ensure timely completion/finalization and identification of issues.
May participate in the Study Oversight meeting(s) with the Study team.
Review time sheets, expense reports and invoices.
Perform other work-related duties as assigned and under the direction of the Senior Director, Clinical Monitoring or Sr. LCRA.