Motivated and detail-oriented research professional skilled at data management, evaluation, building relationships, and educating patients and the community about public health concerns and research efforts.
Certified Tissue Bank Specialist
Certified Quality Inspector
Collaboration with VICC Office of Patient and Community Education to create educational material for patients.
Design data collection forms, known as case report forms (CRFs) coordinating with the ethics committee, which safeguards the rights, safety and well-being of all trial subjects managing regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs liaising with doctors/consultants or investigators on conducting the trial monitoring the trial throughout its duration, which involves remote visiting the trial sites on a regular basis verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV) collecting completed CRFs
from hospitals and general practices writing visit reports and filing and collating trial documentation and reports ensuring all unused trial supplies are accounted for discussing results with a medical statistician, who usually writes technical trial reports archiving study documentation and correspondence preparing final reports and occasionally manuscripts for publication ensuring all AEs and SAEs are
reported appropriately to the IRB and FDA Identify deviations and collaborate with quality staff to determine CAPA and ensure follow through in CAP requirements.
Research: aseptic technique, maintaining medical records, clinical research, clinical trials, conferences, data collection, filing, graphs, venipuncture in animals, obtaining vital signs, education and training Regulatory: GCP, HIPPA, SAE reporting, data monitoring, quality control and compliance, protection of human subjects, FDA regulation Training: mentoring, process improvement, quality improvement, safety, education and training
Regulatory: GCP, HIPPA, SAE reporting, data monitoring, quality control and compliance, protection of human subjects, FDA regulation
Training: mentoring, process improvement, quality improvement, safety, education and training
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