Job Overview: -Site monitoring visits to perform source data verification, documentation of informed consent and drug accountability; EA reporting; and verify protocol, GP, and regulatory compliance -Prepare and distribute site monitoring reports within established timelines -Work with sites to resolve data discrepancies -Conduct training sessions for site personnel on GP, study protocol requirements, company's data systems, and data management practices *No Travel required for this positionJob Description* Performs site level drug accountability, reconciliation and destruction activities.
Verify storage and shipment requirements are within study standards.
Ensure timely completion of paperwork for shipment and storage deviations.
* Verify storage and shipment of biological samples and other protocol specific diagnostic requirements.
* Ensure regulatory files at the sites and in NI archives are current and in compliance with GCPs and NI SOPs.
Verify timely submission of study documentation (including AEs/SAEs/Pregnancy Forms/safety reporting) according to local and NI requirements.
* Responsible to ensure quality of the data recorded at the site as well as retrieved meet expectations.
Accountable for meeting data retrieval timelines.
* Attends protocol training, teleconferences/web meetings, including timely follow-up of action items as requested.
* Build and maintain professional relationships with clinical investigative sites by communicating in an effective, consistent and timely manner.
Previous experience with Electronic Data Capture (DEC) and a Clinical Trial Management System preferred.
Required Skills: 3 yrs experience monitoring, CRC experience 2-5 yrs, CLINICAL ONCOLOGY STUDIES, INFECTIOUS DISEASEJoin Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation.
Due to our growth, we’re constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities.
At Aerotek Scientific, we know it’s more than just your day-to-day responsibilities that can make or break a job. It’s the support you get. That’s the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more.
Don’t put your career in the hands of just anyone, put it in the hands of a specialist.
Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers and will consider all applications without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law.
Clinical Research Associate MD Job in Bethesda 20825, Maryland US
lans, implements safety policy & procedures in Compliance with Federal/State rules and regulations.