Experienced CRA II/Sr CRA - US Northeast Region - Multiple Therapeutic Areas

Before you apply

Job source

Himalayas

Applying on

himalayas.app

Workplace

Fully remote

US state

Nationwide remote

Category

IT

Link last checked

Not checked yet

Posted

4 days ago

Closes

11/13/2026

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About the role

Job Title: Experienced CRA II/Sr CRA - US Northeast Region - Multiple Therapeutic Areas Job Location: Remote, Massachusetts, USA Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Job Description Join Us as an FSO Experienced CRAs – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotech, spanning 2,700 clinical trials across 100+ countries in the last five years. As part of our global team, you'll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix. As part of our global team, you’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix. Education and Experience Requirements: Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 year of travel monitoring experience is required) Ideally looking for respiratory or cardiovascular therapeutic areas preferred. Valid driver's license where applicable. Candidates must live within 60 miles of the nearest major airport. Up to 80% travel is expected. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, including a drug screening. Knowledge, Skills and Abilities: • Proven clinical monitoring skills • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology • Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents • Well-developed critical thinking skills, including but not limited to: critical mindset, in-depthinvestigation for appropriate root cause analysis and problem solving • Ability to manage Risk Based Monitoring concepts and processes • Good oral and written communication skills, with the ability to communicate effectively with medical personnel • Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues • Good organizational and time management skills • Effective interpersonal skills • Attention to detail • Ability to remain flexibile and adaptable in

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