Job Description

ABOUT THE ROLEThis role will assist with the coordination of research in an exciting new environment, with the full backing of a new type of research architecture and a top-tier technology team, challenging the paper-heavy, old-school way that studies are run. This role will require the desire to learn and grow rapidly, and include the opportunity to work closely with Topography’s partner healthcare groups. This role will be evaluated on patient experience, protocol management and adherence, and data quality. You will need to be able to thrive with multiple balls in the air, and where independent problem solving is a daily need. You will need to lead with empathy for patients, and care deeply about creating new access to clinical research in communities across the country.

KEY RESPONSIBILITIESAct as research assistant to clinical trials conducted within physician practices, including but not limited to:Visit preparation activitiesVisit follow-up activitiesSupply and inventory coordinationThird party vendor coordinationPatient recruitment and identificationAssist with patient study visitsAssist with clinical and lab procedures such as ECG, phlebotomy, vitals signs and body measurements, laboratory processing, etc.Assist with the informed consent process with care and quality Adhere to study protocol and GCPProvide high quality source data capture and documentationSupporting the IP distribution and accountability processAdverse Event tracking and follow-upData entry to CRF/EDC and query resolutionProtocol deviation tracking, reporting, and reconciliationAttending sponsor visits including SIVs, IMVs, and COVs, as neededUse and help improve Topography’s proprietary tool setUnderstand and comply with all regulations, policies, and guidelines applicable to clinical research, including our SOPsFollow the study protocolsMaintain meticulous accuracy in completing all documentationAny other duties assigned by manager 

MINIMUM QUALIFICATIONSHigh School Diploma or EquivalentKnowledge of FDA regulations and ICH/GCP guidelinesAbility to draw blood, run labs, take vitalsStrong communication skills, teamwork, cooperation, self-awareness, and flexibility