Address
Form of workJob Summary:
Prepares and submits large and/or complex protocols and supporting documentation to regulatory bodies and research committees involved in the pre-award and post-award process. This includes initial IRB applications, continuations and amendments as well as IND and FDA applications, preparing for and coordinating monitor visits and internal/external audits, ICF development, and ensuring completion and maintenance of regulatory documentation across study lifecycle. This role is a Team Lead and evaluates and works to improve the operational workflow by establishing priorities and delegating tasks within the unit.
- Prepares and submits continuations and amendments to ensure compliance with regulatory requirements and institutional polices.
- Advises and directs the regulatory documentation workflow within the unit as well as provides consultation to staff engaging in new clinical trails
- Develops and governs the standard operation procedures in order to achieve consistent results
- Develops and trains internal and external customers on regulatory workflows.
- Leads the implementation of new applications and/or systems within the unit
- Responds to escalated data requests and questions.
- Leads cross functional meetings and provides updates on the status of all regulatory submissions.
- Coordinates site qualification visits with industry sponsors.
- Identifies quality and performance improvement opportunities and provides recommendations to improve operational efficiency within the unit.
Qualifications:
- Bachelor's Degree required.
- CCRP certification preferred.
- 5 years regulatory/research experience required.
Physical Demands:
Sitting, standing, walking
