Job Details
Highlights
- $70,000 - $80,000 salary + up to 10% bonus!
- Remote on Fridays!
- Fast growing company with tons of opportunity!
- Focus on Quality and Risk Management for Clinical Research!
**This is an on site position M-Th in Plymouth Meeting, PA. Candidates willing to relocate will be considered, but there is NOT a relocation package at this time**
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 responsible for helping the Clinical Research Site Management team get a holistic picture of what the risks are at the clinical research site:-
- Assess risk and create action plans on how to manage or mitigate that risk
- Lead and facilitate identification, investigation, and remediation of quality issues
- When a Quality issue arises, work to identify the root cause of the issue by running Root Cause Analysis and creating preventative actions.
- Facilitate development of robust corrective and preventive actions (CAPA).
- Lead team meetings on how to run CAPAs
- Assist with audit prep and conduct audits/inspections. Also support audit/inspections by sponsors.
- Partner with project teams to maintain an inspection-readiness
- Maintain compliance standards according to company, local, and federal laws
Requirements
- 3+ years experience working with Sponsor Backed clinical research trials
- 2+ years with a focus on quality and risk in clinical trials
- Experience with Root Cause Analysis and CAPA