Senior In-House Clinical Research Associate Job in Gaithersburg 20876, Maryland US
Our client is looking for a Senior In-House Clinical Research Associate to join a large Pharmaceutical organization in Gaithersburg, MD. Sponsor experience with Oncology is required. This is a 6 month contract and we are looking to interview immediately. Duties are standard for a sponsor company, in-house CRA position, centered mostly on managing our contract monitors, site issues, and data quality.
Job Responsibilities:
· Work with Clinical Project Management
· Oversee protocol development and other critical study documents and templates.
· Participate in protocol and informed Consent Form review sessions
· Work with Clinical Trial Team to ensure timely resolution of clinical trial project issues
· Use e-clinical components of the study (E.G IXRS, EDC, CTMS, Etc)
· Defining and testing data checks, system User Acceptance Testing
· Manage contract monitors and site issues
· Ensure clinical staff are assigned to specific clinical research projects, complete task in accordance with the project guidelines, policies, ICH-GCP, application regulations, and applicable SOPs