Highlights
- $50,000 - $65,000 salary
- Full Benefits and Consistent M-F schedule
- Stepping stone into Regulatory focused careers
**This is an on site position in Ravenswood area of Chicago. Please do not apply if you are seeking Hybrid or remote**
The Company:
Our client is a clinical research site management organization that has a proven track record of success in clinical research. They have partnership with a vast network of community based physicians and they make it easier for diverse patient populations to participate in clinical trials and by consistently delivering reliable results & quality data. They are fast growing, constantly partnering and acquiring new sites and organizations! They are on track to become one of the largest site networks in the country!
The Role:
You will be helping with IRB Submissions, training, adhering to SOPs and Guidelines, helping the research staff with internal audits, ensuring they adhere to protocols, and helping with deviations and ICFs.
- Represent site in a professional way when interacting with site staff, sponsors, IRBs, patients/subjects, nursing and medical staff
- Facilitate the initiation of new studies, including protocol development and regulatory submissions.
- Completion and accurate submission of all amendments to the Institutional Review Board (IRB), adhering to regulatory guidelines and protocols.
- Editing and reviewing Informed Consent Documents to ensure clarity, accuracy, and compliance with regulatory standards.
- Compile and prepare comprehensive progress reports for IRB renewal of ongoing studies, summarizing key findings and milestones achieved.
- Facilitate the collection, completion, and submission of regulatory documents to various regulatory entities, ensuring compliance with regulatory requirements.
- Maintenance of Regulatory Binders
- Review and process safety reports to the IRB
Qualifications:
- Bachelor's Degree
- Experience working with clinical research regulatory documentation
**CRCs or Assistants looking to transition their career to focus on regulatory high encouraged to apply!**
