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FSP CRA I & CRA II - Respiratory & Cardiovascular - Southeast region
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Full-time
bachelor degree
Posted 4d ago
~40 hrs/week
Remote in Orlando, Florida, United States
Responsibilities
You will coordinate all aspects of clinical monitoring and site management to ensure trials adhere to protocols, ICH-GCP guidelines, and regulatory requirements. This involves conducting remote or on-site visits to assess compliance, manage documentation, and maintain collaborative relationships with investigational sites.
Requirements
Candidates must hold a bachelor's degree in a life science field or a Registered Nursing certification, along with at least 6 months of travel monitoring experience. Proficiency in respiratory and cardiovascular therapeutic areas is preferred, and the role requires 60-80% travel.
Full job description
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as an FSP Clinical Research Associate (Level I & Level II) – 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 6 months minimum of travel monitoring is required)
Candidates must live within 60 miles of the nearest major airport. 60- 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 a wide range of scenarios • Ability to work in a team or independently as required • Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software • Good English language and grammar skills • Good presentation skills
Working Conditions and Environment: • Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment. • Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays. • Exposure to biological fluids with potential exposure to infectious organisms. • Personal protective equipment required such as protective eyewear, garments and gloves. • Exposure to fluctuating and/or extreme temperatures on rare occasions
Related keywords
Clinical Research AssociateFSPClinical TrialsRespiratoryCardiovascularICH-GCPSOPsRegulatory ComplianceSite ManagementRisk Based MonitoringLife ScienceRegistered NurseCOPDAsthmaData ReliabilityAudit Readiness
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
For more information, please visit www.thermofisher.com.
Offices: 168 Third Avenue, Waltham, MA, US
Analytical InstrumentsLaboratory Supply Chain Programs and eCommerceLaboratory EquipmentLab ServicesSpecialty DiagnosticsLife SciencesPharma Servicesand CDMOElectronicsHealth Care
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