What are the responsibilities and job description for the Clinical Research Regulatory Specialist - Now Hiring position at Actalent?
Seeking a Clinical Research Regulatory Specialist
Description:
- Organizes and maintains the regulatory binder; file essential documents, obtain signatures for delegation logs, training logs and other essential study documents.
- Reviews sponsor template and site level Informed Consent Forms (ICF) to assure compliance with GCP and International Conference on Harmonization (ICH) guidelines.
- Participates in the regulatory review, preparation, and submission of clinical study documentation (e.g. investigator brochure, Investigational Device Exemption (IDE), Investigational New Drug (IND), treatment and compassionate/emergent use, etc) as required.
- Ensures timeliness and accurate submission of all protocol amendments, ICF, Investigator Brochure and other administrative items to the IRB of record.
- Arranges for receipt and/or transmission of administrative and regulatory documents and files Serious Adverse Event (SAE) and IND safety reports.
- Reviews and interprets IRB correspondence with the research team and notifies team of all determinations that may affect the safety and welfare of human subjects.
Experience Level:
Intermediate Level
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Salary : $22 - $40
