Sponsor Perm Remote Site Manager
Our Sponsor is seeking multiple high-quality Remote Site Managers / CRA IIs who are excited to join their team as permanent employees. This is an exceptional opportunity to work directly with a Sponsor whose life-saving products are impacting thousands of patients every year, while offering a collaborative environment and strong growth potential.
The Site Manager role is primarily remote, with approximately 10% travel that is mainly for team meetings. Candidates must have at least two years of experience as a Remote Site Manager or CRA within a CRO or Sponsor organization, be located in the United States, and hold a Bachelor’s degree. Study Start-Up experience is required, and while Cardiology or Medical Device experience is not mandatory, it is considered a plus.
If you’re looking for a long-term opportunity with a mission-driven organization that values its employees and is driving innovation in patient care, apply below!
- Act as the "Site Manager" ensuring relationship with site(s) are positive, issues are resolved quickly, and communications are strong across all verticals.
- Assist with the development of study manuals, CRFs, monitoring standards, site study tools and other study materials as required.
- Develop and implement site recruitment, selection and initiation plan.
- Manage and drive patient recruitment and enrollment tracking.
- Provide training to sites on the study protocol, study conduct, CRF completion and data management expectations.
- Ensure essential document collection for completeness per regulatory requirements.
- Serve as a liaison with Investigators, Institutions and sites to provide support during the conduct of the clinical trial and serve as a resource for protocol and procedures.
- Demonstrate knowledge of on-site monitoring to ensure compliance with GCPs, study protocols, and SOPs.
Manage one or multiple studies. - Monitor product supplies/accountability including proper storage, dispensation, and disposal.
- Manage study completion activities including CRF collection, query resolution, record archiving and site closeout activities.
- Review in-house data and study tables.
- Mentor, coach and provide guidance to clinical staff as appropriate.
- Supervise and train other employees as appropriate.
- Must have at least 2 years' recent experience working as a CRA/Site Manager for a CRO or Sponsor
- 100% Utilization required
- Must be located in the US
- Must be able to do 10% travel, mainly for team meetings
- Study Startup experience required
- A Bachelor's degree is required
- No therapeutics are required, but it is a plus if you have experience working in Cardiology, Device, and/or Cardiac Device experience, in any role
- It is a plus if you are fluent in French
- It is a plus if you have experience with Health Canada
- It is a plus if you have RBM experience (Risk-Based Monitoring)
- It is a plus if you have experience with Inpatient or surgical, in any role
- Competitive Hourly Rate (Pay is in alignment with experience level)