Performs and coordinates all aspects of the clinical monitoring and site management process
Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation
Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs
Ensures audit readiness
Develops collaborative relationships with investigational sites

Requirements

Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification
Must be legally authorized to work in the United States without sponsorship
CRA Level II: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 year as a clinical research monitor)
Sr CRA Level I: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor)
Proven clinical monitoring skills, ideal candidates will have monitoring experience with oncology, HIV, respiratory and or vaccine/flu
Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software

Benefits

A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical monitoringsite managementprotocol complianceregulatory compliancedocumentation managementaudit readinessoncology monitoringHIV monitoringrespiratory monitoringvaccine monitoring

Soft Skills

collaborative relationshipsinterpersonal skills

Certifications

Bachelor's degree in life sciencesRegistered Nursing certification