Description
Clinical Trial Management responsibilities:Assist with the identification, selection and monitoring of investigational sites for clinical studies; prepare accurate and timely visit reports from all site interaction visits
Develop and maintain good working relationships with investigators and study staff, serving as an ambassador to promote the company high quality and ethical standards
Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures
Track progress of study including patient enrollment, monitoring visits
Review key study quality metrics (e.g., eligibility, tumor assessments, primary endpoint data, etc.) and follow-up with the SET to determine appropriate action
Investigate queries, monitor discrepancies
Manage investigational product (IP) accountability and reconciliation process
Responsible for the review of IP release packages
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Assist with the negotiation and management of the budget and payments for investigative sites, if applicable -
Contribute to the preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents -
Assist with clinical data review of data listings and summary tables, including query generation -
Partner with 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 -
Ensures that all essential clinical documents and business documents are in place for assigned sites to ensure timely site initiation and subject/patient enrollment
Maintains all essential clinical documents and business throughout the assigned clinical study
Requirements:
Minimum of 3 years of clinical research monitoring experience (including site qualification, initiation, routine monitoring, and closeout visits)
Oncology experience preferable
Good computer skills (MS Office)
Strong working knowledge of FDA & ICH/GCP regulations and guidelines
Thorough knowledge of clinical monitoring procedures
Good analytical and assessment skills
Good judgment and problem solving skills
To find out more about Real please visit www.realstaffing.com