Abby A.

About Abby A.

Seasoned CRA with over 7 years of clinical monitoring experience. Excellent knowledge in…

Experience

1. Senior Clinical Research Associate

   Corbus Pharmaceuticals

   Apr 2019 — Present

   Perform investigator site pre-study site qualification visits including collection of site regulatory documents • Assist with site start-up activities including site contracts and budget development/negotiation, and preparation of IRB submissions • Prepare the study reference manual, including liaising with the Contract Research Organization (CRO) team (i.e, central lab, specialty labs and vendors) to ensure efficient preparation and delivery of study materials to investigator sites • Responsible for ensuring investigator sites have met all contractual and regulatory requirements for site initiation and first release of study drug • Participate in Investigator Meetings, ensuring the study staff conducting the study have received the proper materials, instructions and training to safely and accurately conduct the study in line with protocol requirements • Assist in the development of study/program plans • Track the movement of laboratory samples and the resulting data, including the trans-shipment of samples to specialty laboratories, or movement of samples to sample-management storage. • Manage patient recruitment strategies, proactively identifying barriers to recruitment while proposing solutions (i.e, study-site webinars, newsletters or other potential creative solutions) • Monitor recruitment, data quality and patient safety while on site and remotely through EDC systems and direct site communication • Liaise with study site personnel to ensure timely and correct entry of data into eCRF, including the timely resolution of data queries • Identify and complete follow- up of SAEs at study sites • Assist with data listing, data coding, patient profile reviews, database lock, and site close-out activities • Ensure appropriate and timely submission of documents to the Trial Master File • Reviewing and approving trip reports. • Mentoring and training new CRA’s. • Performing Central monitoring for US and ROW.