Description
Duties:-Identify, select, and monitor investigational sites for clinical studies; prepare accurate and timely visit reports from all site interaction visits; review and finalize visit reports
-Develop and maintain good working relationships with investigators and study staff
-Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures
-Track and report on progress of study including site activation, patient enrollment, monitoring visits
-Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and follow-up with study leadership to determine appropriate action
-Investigate queries, monitor discrepancies
-Manage investigational product (IP) accountability and reconciliation process
-Responsible for review of IP release packages
-Support the payments for investigative sites, if applicable
-Contribute to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents
-Clinical data review of data listings and summary tables, including query generation
-Oversee performance of CROs, third party vendors, and field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to manager or CRO as appropriate
-Perform initial review of CRO and other third party study vendor invoices to ensure that work is performed in accordance with scope of work
-Assist with CRA and third party vendor training on protocols and practices
-Assist in identification and hiring of appropriate CROs and third party study vendors
-Other duties as assigned
Experience:
-Sponsor experience preferable
-Cardiovascular and/or late-stage study experience preferable
-Previous experience working with an electronic data capture system and CTMS system required
-Proficient with MS Word, Excel, Project and PowerPoint. Experience with MS Access and MS Project a plus
-Strong interpersonal, communication (written and verbal), and organizational skills
-Demonstrated ability to work independently as well as part of a multi-functional study team
-Able to motivate a team to work effectively under a changing environment
-Able to solve problems under pressure