Clinical Research Monitor 1, Research Administration, FT, 08:30A-5P jobs in United States
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Baptist Health · 1 day ago

Clinical Research Monitor 1, Research Administration, FT, 08:30A-5P

Baptist Health is the region’s largest not-for-profit healthcare organization, and they are seeking a Clinical Research Monitor to oversee study site monitoring. The role involves conducting site visits, ensuring compliance with regulatory requirements, and maintaining the integrity of clinical data.

Hospital & Health Care
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H1B Sponsor Likelynote

Responsibilities

Perform site visits (on-site or remotely), including Pre-Study, Initiation, Routine and Closeout visits
Ensure study staff have received the proper materials and instructions to safely enter patients into the study
Review completion of proper informed consent procedures according to the applicable regulatory requirements
Ensure the integrity of the data
Interpret data to identify protocol deviations and risks to subject safety/data integrity
Generate queries and manage resolutions with site personnel
Perform investigational product accountability as per the protocol and Study Monitoring Plan
Evaluate execution of study protocol at the site level
Conduct audits of essential regulatory documents to ensure completeness, accuracy, and regulatory compliance
Document activities via confirmation letters, follow-up letters and other required study documents as per SOP and Study Monitoring Plan

Qualification

Clinical Practice (GCP)FDA RulesRegulationsClinical Trials KnowledgeCertified Clinical Research Associate (CCRA)Oncology ExperienceMulti-taskingComputer SkillsAnatomyMedical TerminologyProblem SolvingCommunication Skills

Required

Bachelors Degree is required
Ability to problem solve and multi-task, excellent computer skills
Proficient in Windows, MS Word, Excel
Possesses knowledge of Good Clinical Practice (GCP), FDA Rules and Regulations in relation to clinical trials, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical trials, and NCI common toxicity definitions
Knowledge of basic human anatomy, physiology, medical terminology
Ability to communicate effectively and with a high level of professionalism across various stakeholders
Minimum Required Experience: 5 Years

Preferred

Master‘s degree and CCRA (Certified Clinical Research Associate)
Prior experience in Oncology

Company

Baptist Health

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Baptist Health South Florida is the region’s largest not-for-profit healthcare organization with 12 hospitals, more than 29,000 employees, 4,500 physicians, and 200 outpatient centers, urgent care facilities, and physician practices spanning across Miami-Dade, Monroe, Broward, and Palm Beach counties.

H1B Sponsorship

Baptist Health has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (4)
2023 (2)
2022 (3)
2021 (20)
2020 (6)

Funding

Current Stage
Late Stage

Leadership Team

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Bill Ulbricht
Chief Executive Officer - Baptist Hospital Miami
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Drew Grossman
Chief Executive Officer
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Company data provided by crunchbase