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.
Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.).
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 to guarantee subjects rights, well-being and data reliability.
Ensures audit readiness.
Develops collaborative relationships with investigational sites.
Monitors investigator sites with a risk-based monitoring approach.

Requirements

Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1+ year as a clinical research monitor)
Valid driver's license where applicable.
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

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 compliancerisk-based monitoringdocumentation managementaudit readinessICH-GCP guidelinesSOPs

Soft Skills

collaborative relationshipsinterpersonal skills

Certifications

Bachelor's degree in life sciencesRegistered Nursing certification