Participate in the development of NDA including general medical report and safety summaries.Participate in analysis of collect data from cancer patients.Insure follow up of SAE data by liaison with clinical study monitors, name safety contacts and CROs as appropriate.Develop an understanding of the clinical research/trial process in compliance with standard operating procedures (HIPAA, etc.Transfer the clinical measurement methods used to local CRO so they can perform testing at a significant cost reduction.Coordinate the release of client medical records and create detail summary forms of clients' oncology and medical histories.Interact with investigators and think leaders in oncology to facilitate the design of clinical synopses and protocols.Follow GCP, GLP and CLIA laboratory standards to prepare, carry out and report experiments.Evaluate CROs and vendors (patient recruiting services, labs, centralize ECG, etc.Review serious adverse event reports receive from other local country sectors for expediting to the FDA.Identify grant funding opportunities and prepare scientific grant applications (NIH and non-NIH).Conduct multiple HIPAA training sessions.Function as member of the FDA audit preparation team in support of the filed NDA.Manage and work collaboratively with CRO management to initiate and update contract/consultancy agreements/amendments on an ongoing basis.
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