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.

Job Type: Contract
Pay: $40.00 - $50.00 per hour
Expected hours: 40 per week
Work Location: In perso

• 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