Clinical Research Associate

Hungarotrial; Town of Poland (NY); Remote; USD 70,000 - 95,000; Full time

Benefits offered by this job

Attractive and competitive salary

Dedicated and supportive team

Multinational environment

Regular team buildings and company events

Full home based work possible

Job summary

A health care company is seeking a Clinical Research Associate to manage clinical trials while ensuring compliance with regulations and ICH-GCP guidelines. Responsibilities include initiating, monitoring, and closing studies, preparing regulatory submissions, and supporting contracting processes. Required qualifications include a bachelor's degree in life sciences and at least two years of CRA experience. The role offers an attractive salary and a supportive team environment, with remote working options available.

Qualifications

• Minimum of 2 years experience in CRA role.
• Advanced level of English.
• Valid Driver’s license.
• Driver’s license.
• Strong communication and teamwork.

Responsibilities

• Initiate, monitor, and close-out clinical studies as per regulations.
• Prepare regulatory and ethics submissions for approval.
• Support contracting procedures between sponsor and sites.
• Document activities following ICH-GCP and SOPs.
• Prepare activity summaries as required by the Manager.

Skills

Effective communication

Customer focus

Teamwork

Time management

Motivation to learn and develop

Education

Bachelor degree in life sciences

Job description

As a Clinical Research Associate you will be responsible for a variety of monitoring tasks and you will have a chance to work on clinical studies in different therapeutic indications, ensuring the clinical trial is conducted in compliance with study protocol and procedures, ICH-GCP guidelines and the applicable regulations and SOPs.

Main duties and responsibilities

• Initiate, monitor and close-out clinical studies on study sites in accordance with applicable regulations, guidelines of ICH-GCP and standard operation procedures;
• Prepare and perform regulatory and ethics submission (drug, medical device, non-interventional) for approval in accordance with applicable regulations, guidelines of ICH GCP and standard operation procedures of HungaroTrial (e.g. able to perform initial CA and EC submissions, amendment, notification, progress and safety report submissions, contract negotiations without direct supervision);
• Support contracting procedure between Sponsor and Investigational sites;
• Perform feasibilities and pre-study evaluations;
• Document activity in accordance with ICH-GCP and standard operation procedures of HungaroTrial;
• Prepare a summary (report) of activities as requested by the Manager.

Requirements

• Bachelor degree in life sciences
• at least 2 years experience in CRA role
• Advanced level of English
• Driver’s license
• effective communication, customer focus, teamwork, time management, motivation to learn and develop

What we can offer

• Attractive and competitive salary
• Dedicated and supportive team
• Multinational environment
• Regular team buildings and company events
• full home based work is possible

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