Job Title : Clinical Research Site Manager
Job Description
We are seeking a Clinical Research Site Manager for our site in Waco, Texas. The Site Manager will lead a team of two Clinical Research Coordinators (CRC) and focus on driving the site and physicians forward.
The Waco market currently has 12 cardiologists who need management and education, as they are research-naïve. The ideal candidate will have experience running a site, especially with multiple Principal Investigators (PIs).
You will coordinate the execution of clinical study protocols while maintaining Good Clinical Practice (GCP) and adhering to FDA regulations.
Your main responsibilities include conducting multiple clinical trials, working closely with the Principal Investigator, Sub-Investigators, and support staff.
Hard Skills
- Interpreting protocols
- Educating patients and healthcare professionals on study protocols
- Reviewing medical records for inclusion / exclusion criteria
- Presenting information and responding to questions professionally
- Maintaining and preparing lab kits
- Coordinating subject visits with the Investigator Team
- Maintaining clinical source records
- Organizing Investigator Site Files
- Ensuring accurate call notes and documentation
- Complying with regulatory requirements and guidelines
- Preparing IRB submissions and regulatory documents
- Coordinating and maintaining necessary logs
- Coordinating site training
- Transcribing source data to EDC platforms
- Hosting sponsor and monitor visits
Soft Skills
- Integrity
- Teamwork
- Respect
- Accountability
Job Type
This is a permanent position.
Work Site
This is a fully on-site position in Waco, Texas.
Work Environment
This is an onsite position based in Waco, Texas, working 5 days a week.