Clinical Research Monitor 1, Research Administration

Baptist Health is the region’s largest not-for-profit healthcare organization, with 12 hospitals, over 28,000 employees, 4,500 physicians and 200 outpatient centers, urgent care facilities and physician practices across Miami-Dade, Monroe, Broward and Palm Beach counties. With internationally renowned centers of excellence in cancer, cardiovascular care, orthopedics and sports medicine, and neurosciences, Baptist Health is supported by philanthropy and driven by its faith-based mission of medical excellence. For 25 years, we’ve been named one of Fortune’s 100 Best Companies to Work For, and in the 2024-2025 U.S. News & World Report Best Hospital Rankings, Baptist Health was the most awarded healthcare system in South Florida, earning 45 high-performing honors.

What truly sets us apart is our people. At Baptist Health, we create personal connections with our colleagues that go beyond the workplace, and we form meaningful relationships with patients and their families that extend beyond delivering care. Many of us have walked in our patients’ shoes ourselves and that shared experience fuels out commitment to compassion and quality. Our culture is rooted in purpose, and every team member plays a part in making a positive impact – because when it comes to caring for people, we’re all in.

Description:

The Clinical Research Monitor will be responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, with or without guidance. Responsible for all aspects of monitoring management as prescribed in the monitoring plan. (S)he is responsible to: 1) Perform site visits (on-site or remotely), including Pre-Study, Initiation, Routine and Closeout visits, 2) Ensure study staff have received the proper materials and instructions to safely enter patients into the study, 3) Review completion of proper informed consent procedures according to the applicable regulatory requirements, 4) Ensure the integrity of the data, 5) Interpret data to identify protocol deviations and risks to subject safety/data integrity, 6) Generate queries and manage resolutions with site personnel, 7) Perform investigational product accountability as per the protocol and Study Monitoring Plan, 8) Evaluate execution of study protocol at the site level, 9) Conduct audits of essential regulatory documents to ensure completeness, accuracy, and regulatory compliance, 10) Document activities via confirmation letters, follow-up letters and other required study documents as per SOP and Study Monitoring Plan. Estimated salary range for this position is $65835.36 - $85585.97 / year depending on experience.

Qualifications:

Degrees:

• Bachelors.

Additional Qualifications:

• Bachelor‘s degree required.
• Master‘s degree and CCRA (Certified Clinical Research Associate) preferred.
• 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.
• Prior experience in Oncology preferred.
• Ability to communicate effectively and with a high level of professionalism across various stakeholders.

Minimum Required Experience: 5 Years

EOE, including disability/vets