Overview

Clinical Research Associate I/II/Sr Job at Axsome Therapeutics – Remote

Axsome Therapeutics is currently searching for a Clinical Research Associate.

JOB SUMMARY

The CRA will be responsible for site management and monitoring activities at assigned sites across assigned programs and ensuring the trial is conducted in compliance with the protocol, ICH/GCP, applicable regulatory requirements, and applicable SOPs or Work Instructions. A CRA may be selected to function as the Lead CRA on a study.

JOB RESPONSIBILITIES

Assist with the execution and the timely implementation of clinical research activities for assigned projects

Perform clinical monitoring activities (site evaluation, initiation, interim monitoring visits, remote, and close-out) and provides overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations

The Lead CRA role also tracks site performance metrics

Monitor investigative sites and activities to verify the protocol is being followed and study activities are being performed by sites are being met

Create thorough monitoring visit reports

Act as primary point of contact for assigned investigational sites and cross functional teams and escalates to the study lead, as necessary

The Lead CRA supports the development/review of clinical study plans, presentations or project/study-related documents related to monitoring activities

Perform and potentially lead in-house review of clinical data listings for completeness and accuracy and escalate issues to the Lead CRA or CTM and Study Director, as needed

Responsible to verify study newsletters are present in the Investigator Site File and tracking/reporting of recruitment updates for their assigned sites

Participates in the evaluation and training of investigative sites

In a lead role, a CRA could assists with providing oversight of CROs, contract CRA(s) and vendors, including being a liaison for cross-functional teams

In a lead role, a CRA could reviews monitoring trip reports and track resolution of all action items

May participate in co-monitoring and/or training visits with junior team members for training purposes

Assist with the organization and management of internal team meetings, investigator meetings, and other trial specific meetings, as required

Maintain completion of required corporate training on standards, policies, and work instructions

Perform other work-related duties as assigned and under the direction of the Clinical Trial Manager or Director

REQUIRED EDUCATION AND EXPERIENCE

BA/BS or equivalent degree in a scientific discipline or related healthcare field preferred, but not required

Minimum of 3 years of clinical trial experience in a pharmaceutical, biotechnology, CRO, and/or healthcare setting (including 1+ years on-site monitoring experience)

Demonstrates core understanding of medical terminology or clinical trial activities

Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines

Ability to work on complex or multiple projects and exercise critical thinking with minimal supervision

Solid attention to detail and excellent organization skills

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

Demonstrates problem solving and leadership skills

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

Willingness to travel (up to 70%)

Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities

Experience in interactions with outside vendors, e.g., CROs and other vendors preferred

Experience in CNS preferred

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About the Company

Company: Axsome Therapeutics –

Company Location:  Remote

Estimated Salary:

About Axsome Therapeutics -