Execute, manage and conduct projects associated with the company clinical study plans.
Responsible for site management deliverables on assigned protocols and may act as a lead CRA for the study, providing guidance and support to other CRAs on the team.
Establish and maintain primary Sponsor communication with clinical sites for in-house and outsourced studies.
Conduct oversight visits for outsourced studies to promote study engagement, enrollment and foster sponsor/site relationships.
Serve as a point of contact for investigators and site staff.
Maintain regular contact with study sites to ensure GCP/ICH/Protocol compliance, assessment of accrual rates.
Facilitate communication between the project team and site personnel to ensure that they are appropriately trained and remain current with project requirements.
Support the Clinical Study Manager in developing study-specific training materials.
Conduct thorough site qualifications visits and efficient site initiation visits.

Bachelor’s Degree in field as outlined in essential duties or Associate degree with a minimum of 6 years of monitoring experience or equivalent experience.
Highschool Diploma with a minimum 8 years of monitoring experience or equivalent experience.
4+ years clinical research monitoring experience or equivalent experience.
Proficiency in data management, including progressive experience in data entry, validation, and cleaning.
Familiarity with Electronic Data Capture (EDC) systems.
Understanding of regulatory compliance to ensure adherence to applicable regulations and requirements.
Knowledge and experience in informed consent procedures, adverse event reporting, documentation, and record-keeping practices.
Meticulousness with a focus on accuracy and precision in all tasks and activities.
Demonstrated ability to work well within a team and convey information effectively.
Authorization to work in the United States without sponsorship.

paid time off (including days for vacation, holidays, volunteering, and personal time)
paid leave for parents and caregivers
retirement savings plan
wellness support
health benefits including medical, prescription drug, dental, and vision coverage

Senior Clinical Research Associate

Key skills