Clinical Research Monitor

Position Title: Clinical Research Associate
Department: CTNI, Psychiatry
Location: Remote
Reports to: Director, Operations
Time: Full-time
Status: Exempt

Expectations for All Employees:
Supports the organization's missions, vision and values by exhibiting the following behaviors; excellence and competence, collaboration, innovation, respect, personalization, commitment to our community, and accountability and ownership

Position Summary:

Competencies Required:
* Excellent oral and written communication skills
* Sound interpersonal skills
* Ability to work independently
* Ability to travel up to 50% of time
* Ability to identify problems and develop solutions
* Exceptional attention to detail
* Ability to navigate and utilize multiple online systems and software

The primary responsibility of the Clinical Research Associate is to conduct site monitoring visits in accordance to CTNI's SOP's, ICH GCP guidelines and federal regulations to ensure that 1.) the rights and well-being of human subjects are protected and 2.) electronic case report forms (e-CRF) are accurate, complete, and verifiable from source documents.
Primary Duties:

• Responsible for conducting study monitoring visits (Site Qualification Visit to Close Out Visit) to assess protocol and regulatory compliance per the approved monitoring plan.
• Review and compare source documentation to eCRFs to ensure data is complete and accurate.
• Provide Investigator and study staff training at study initiation and as needed through the course of the trial.
• Review study specific site documents including: regulatory documents, drug accountability logs, training logs, delegation of authority logs
• Maintain regular communication with assigned sites to support site enrollment, data entry, query resolution, and patient retention.
• Document site visit findings and observations via trip reports and letters.
• Escalate major visit findings as described in the monitoring plan to appropriate study team members.
• Participate in weekly meetings with study team.

Other Tasks, as required:

• Participate in the site and/or investigator identification, evaluation, and selection processes.
• Attend and participate in investigator and coordinator meetings, as needed.
• Submit monitoring visit expense reports in a timely manner.
• Assist with central monitoring and site management duties.

Education and Experience:

BA or BS in life sciences related field or registered nursing certificate
Minimum of 3 years monitoring experience
Pain research experience is a plus
Must be knowledgeable of clinical trial systems and Microsoft office applications
Must have the capability to complete primary duties for multiple studies

Benefits:

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund