Sponsor Contract to Perm Clinical Research Associates
We’re seeking an experienced contract-to-perm Clinical Research Associate who is based out of the United States, with at least five years of recent monitoring experience gained directly with a sponsor or CRO. Come join a sponsor that is a recognized innovator in the cardiac device space and has helped thousands of patients through its advanced technologies and therapies. This organization is known for its strong clinical track record, FDA-approved technologies, and a culture that blends collaboration, growth, and a clear, patient-centered mission.
As a Clinical Research Associate here, you won’t just be monitoring studies, you’ll be contributing to meaningful advances in care while working alongside teams who are genuinely passionate about improving patient outcomes.
- 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.
- A minimum of 5 years’ experience as a fully dedicated regional, home based, field monitor for a CRO, Device or pharma is required, with this monitoring experience been no longer than 2 years ago
- Recent experience with site management is required
- Able to travel two weeks out of the month / i.e. - up to 50%
- Must have a Bachelor's degree (preference in Life Sciences but open as long as Bachelor's)
- Must have COVID-19 vaccine
- Experience working on cardiovascular studies is preferred (any experience will be accepted, even as a nurse/MD or coordinator)
- Experience working within a surgical or inpatient environment is preferred (any experience will be accepted, even as a nurse/MD or coordinator)
- Monitoring experience in Device studies is preferred, even stronger if it is in Cardiac Device
- Experience performing Risk-Based monitoring is preferred
- Experience in Study Start-up is preferred, while working directly for a CRO or Sponsor
- It is a plus if you are fluent (speaking and writing) in both English and French and have experience with Health Canada
- It would be wonderful if you have experience mentoring junior level team members
- Competitive hourly to salary rate