Clinical Research Monitor 1, Research Administration, FT, 08:30A-5P
About The Position
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.
Requirements
- Bachelor‘s degree 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
Nice To Haves
- Master‘s degree and CCRA (Certified Clinical Research Associate) preferred.
- Prior experience in Oncology preferred.
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
