Clinical Research Associate Job at HonorVet Technologies

Job Description

The Clinical Research Associate (Monitor) is responsible for supporting clinical activities for domestic and international studies as well as support other related initiatives, as required.

Job Responsibility

Collaborate with team members in the evaluation and establishment of clinical study sites by performing site qualification visits and site initiation visits to ensure applicability of sites for planned study according to application regulatory requirements
Collaborate with Senior Clinical Research Associate to create source documentation/CRFs in alignment with protocol requirements
Collaborate with sites and internal stakeholders to align and implement site specific language for each consent/assent and support Institutional Review Board (IRB) submissions
Train site staff on protocol requirements, source documentation, and case report form completion
Conduct regular monitoring visits to ensure study protocol compliance, primary data collection is recorded properly, and appropriate reporting is being conducted
Conduct clinical study site close-out visits and ensure site files are complete, accurate and up to date
File site related documents real-time to ensure Trial Master Files are complete and accurate at all times
Provide study specific information and support report validation activities as requested for clinical study reports
Participates in team meetings and document meeting minutes and tracks action items
Ensure compliance with SOPs and local regulations, and ICH and GCP guidelines
Performs other duties as required

Requirements

B.S. or B.A. and/or an equivalent combination of education or experience
Minimum of 3 years of experience directly related to the execution of clinical research studies
Available to travel (up to 60%) on short notice and independently manage travel schedules
Must have analytical skills, be detail oriented and have good interpersonal skills
Knowledge of agency guidelines and requirements
Effective written and verbal communication skills
Ability to communicate at all levels of an organization
PC skills
word processing, spreadsheet, database, Internet search and utilization
Flexible and able to work in a fast-paced environment
Team player
Ability to organize and judge priorities
Excellent ability to generate and maintain accurate records

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