Clinical Research Monitor 1, Research Administration, FT, 8A-4:30P
About the position
The Clinical Research Monitor will be responsible for all aspects of study site monitoring, which includes routine monitoring and close-out of clinical sites, maintenance of study files, and conducting pre-study and initiation visits, with or without guidance. This role is crucial in ensuring that clinical trials are conducted in compliance with regulatory requirements and that the integrity of the data is maintained throughout the study. The Clinical Research Monitor will perform site visits, which can be on-site or remote, including Pre-Study, Initiation, Routine, and Closeout visits. They will ensure that study staff have received the proper materials and instructions necessary for safely entering patients into the study. Additionally, the monitor will review the completion of informed consent procedures according to applicable regulatory requirements and ensure the integrity of the data collected during the study. The responsibilities also include interpreting data to identify any protocol deviations and risks to subject safety or data integrity. The Clinical Research Monitor will generate queries and manage resolutions with site personnel, perform investigational product accountability as per the protocol and Study Monitoring Plan, and evaluate the execution of the study protocol at the site level. Conducting audits of essential regulatory documents to ensure completeness, accuracy, and regulatory compliance is also a key responsibility. All activities must be documented via confirmation letters, follow-up letters, and other required study documents as per Standard Operating Procedures (SOP) and the Study Monitoring Plan. The estimated salary range for this position is $64,862.42 - $84,321.15 per year, depending on experience.
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 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.
Requirements
• 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, and Excel.
,
• 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.
,
• Knowledge of basic human anatomy, physiology, and medical terminology.
,
• Prior experience in Oncology preferred.
,
• Ability to communicate effectively and with a high level of professionalism across various stakeholders.
Nice-to-haves
Benefits
Apply Now
The Clinical Research Monitor will be responsible for all aspects of study site monitoring, which includes routine monitoring and close-out of clinical sites, maintenance of study files, and conducting pre-study and initiation visits, with or without guidance. This role is crucial in ensuring that clinical trials are conducted in compliance with regulatory requirements and that the integrity of the data is maintained throughout the study. The Clinical Research Monitor will perform site visits, which can be on-site or remote, including Pre-Study, Initiation, Routine, and Closeout visits. They will ensure that study staff have received the proper materials and instructions necessary for safely entering patients into the study. Additionally, the monitor will review the completion of informed consent procedures according to applicable regulatory requirements and ensure the integrity of the data collected during the study. The responsibilities also include interpreting data to identify any protocol deviations and risks to subject safety or data integrity. The Clinical Research Monitor will generate queries and manage resolutions with site personnel, perform investigational product accountability as per the protocol and Study Monitoring Plan, and evaluate the execution of the study protocol at the site level. Conducting audits of essential regulatory documents to ensure completeness, accuracy, and regulatory compliance is also a key responsibility. All activities must be documented via confirmation letters, follow-up letters, and other required study documents as per Standard Operating Procedures (SOP) and the Study Monitoring Plan. The estimated salary range for this position is $64,862.42 - $84,321.15 per year, depending on experience.
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 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.
Requirements
• 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, and Excel.
,
• 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.
,
• Knowledge of basic human anatomy, physiology, and medical terminology.
,
• Prior experience in Oncology preferred.
,
• Ability to communicate effectively and with a high level of professionalism across various stakeholders.
Nice-to-haves
Benefits
Apply Now