Description
We are seeking Experienced General Medicine Sr. CRAs to lead and support our Full Service Outsourcing team. The successful candidate will be based in a major hub location within the United States and will travel 60-70% of the time, with 8-10 days on site per month.
The role involves utilizing clinical judgement to provide high-quality care for participants in clinical trials and responding to emergency situations based on clinical research standards.
Responsibilities
- Conduct routine monitoring and close-out of clinical sites, maintaining study files, and liaising with vendors
- Manage site activities as outlined in project plans
- Perform general on-site monitoring
- Ensure study staff have necessary materials and instructions to safely enter patients into the study
- Verify informed consent procedures and protocol requirements are followed according to regulatory requirements
- Protect study patients by ensuring data integrity and identifying missing or implausible data
- Manage registry activities as prescribed in project plans, including feasibility work
- Complete Serious Adverse Event (SAE) reporting and follow-up
- Independently review CRFs, generate queries, and resolve issues against established guidelines
- Assist with training new employees and coordinate clinical projects as a Local Project Coordinator
- Perform other duties as assigned by management
Requirements
- University or college degree, or certification in a related allied health profession (e.g., nursing licensure)
- 1-3 years of Clinical Monitoring experience
- Ability to work in a fast-paced environment with changing priorities and constant adaptation
- Strong teamwork and people skills, with the ability to work effectively in a technology-based environment
What do you get?
- Comprehensive benefits package, including medical, dental, vision, life, and disability insurance
- 401(K) plan
- Paid time off (PTO) – Flex Plan
- Employee recognition awards
- Multiple ERG's (employee resource groups)
- Target pay range: $105-140K per year