Clinical Research Monitor 1, Research Administration, FT, 8A-4:30P
1 month ago
Baptist Health South Florida is the largest healthcare organization in the region, with 12 hospitals, more than 24,000 employees, 4,000 physicians and 100 outpatient centers, urgent care facilities and physician practices spanning across Miami-Dade, Monroe, Broward and Palm Beach counties.
A not-for-profit organization supported by philanthropy and committed to its faith-based charitable mission of medical excellence, Baptist Health has been recognized by Fortune as one of the 100 Best Companies to Work For in America and by Ethisphere as one of the World's Most Ethical Companies.
Everything we do at Baptist Health, we do to the best of our ability. That includes supporting our team with extensive training programs, millions of dollars in tuition assistance, comprehensive benefits and more. Working within our award-winning culture means getting the respect and support you need to do your best work ever. Find out why we're all in for helping you be your best.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.
(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 $ $ / 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:
EOE
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