Clinical Research Regulatory Specialist

Job Title :  Clinical Research Regulatory Specialist

Location :  Los Angeles, CA 90025

Duration :  13+ weeks contract

Description :-

Required:

* Bachelor's Degree

* 3 years of relevant clinic research experience

* Regulatory Experience - Ability to strictly adhere to regulatory requirements and ethical guidelines

* Experience with EDC systems (Medidata, VeevaVault, MedRio)

Preferred:

* Experience with Oncology/Chemo

* CCRP strongly preferred

Primary Duties and Responsibilities

• Submits continuations and amendments to ensure compliance with regulatory requirements and institutional polices.

• Completes forms and generates reports from multiple data sources to comply with the assigned protocols for the study and/or clinical trial.

• Maintains research files and may audit documentation pertaining to regulatory requirements for clinical trials.

• Responds to generally broad data requests and questions.

• Monitors the status of assigned regulatory submissions and amendments from end-to-end.

• Partners with research staff and investigators to ensure that all regulatory documents for the assigned research studies are up to date.

• Represents the unit in cross-functional meetings and provides updates on the status of assigned regulatory submissions.

• Supports the unit in internal and external auditing of regulatory documents.

• Identifies quality and performance improvement opportunities to support efficient workflows.

• Maintains strict patient confidentiality according to HIPAA regulations and follows guidance according to applicable law, research practices using Good Clinical Practice (GCP) guidelines.