Monitor and own the progress of clinical studies at investigative sites
Ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards
Coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits)
Work with 2-3 protocols on average and support Project Managers with trials that are larger in scope
Interact directly with clients, initiate payments, and participate in proposal activities, including development and client presentations

Requirements

4-year college degree or equivalent experience
2+ years CRA experience within the CRO to be considered for a CRA II.
Experience in monitoring cardiology or Lupus
Availability for domestic travel including overnight stays, up to approximately 50-60% travel commitment
Fluency in English and for non-English speaking countries the local language of country where position based.

Benefits

Health insurance
401(k) matching
Paid time off
Volunteer time off
Parental leave

Applicant Tracking System Keywords

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

Hard skills

clinical study monitoringregulatory submissionsprotocol adherenceSOPsICH-GCPdata reportinginvestigator identificationpre-study visitsinitiation visitscardiology monitoring

Soft skills

client interactionpresentation skillsorganizational skillscommunication skillsteam collaborationproblem-solvingtime managementadaptabilityattention to detailleadership