Job Description
In this role, the Senior Clinical Research Associate is responsible for field monitoring and management of clinical sites. This position focuses on all activities required to evaluate, initiate, monitor and close clinical sites in compliance with the Code of Federal Regulations and ICH/GCP Guidelines. This role may provide operational input to clinical study teams as directed.Some specifics about this advertised roleAct as liaison between the in-house team, vendors, and multiple clinical sites.Work collaboratively with investigative sites to develop strong, long-term, working relationships.Apply SOPs, Clinical Monitoring Plan (CMP), study manuals and other materials and guidelines as applicable.Help identify and qualify potential investigators. Perform Pre-Study Site Visits.Assist with start-up activities, including essential document review and collection as requested.Perform Site Initiation Visits.Provide initial and ongoing training to site personnel regarding the study protocol, applicable policies/procedures, and GCP.Perform Interim Monitoring Visits for assigned studies.
Responsibilities + Skills
FDA/EMA inspection experience is preferred.Proficiency in CFR and GCP/ICH Guidelines is required. Experience working on global clinical trials is preferred.Proficiency in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint) and other electronic systems (CTMS, EDC and eTMF).
Education
pharmaceutical/biotech experience. RN or health care professional preferred.Prior monitoring experience is required. Oncology/hematology clinical trial experience is essential.
Experience
