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Summary:
Assist the Clinical Operations Team in a multifunctional capacity to carry out all assigned tasks associated with the collection, documentation, and maintenance of clinical data including phlebotomy/laboratory, data entry and administrative responsibilities.
Responsibilities:
study protocol, GCP, ICH Guidelines, and companies SOPs
collection within scope of the protocol and local law and
regulations
phlebotomy, ECG, etc) within scope of the protocol, local law
and regulations
per protocol and IATA regulations, if applicable
related supplies throughout course of the clinical trial
portal and resolve basic queries in a timely manner under the
direction of the Clinical Research Coordinator
sponsors, CROs, and vendors under the direction of the
Clinical Research Team
transferring data to sponsor/CRO data capture systems and
resolving queries under the direction of the Clinical Research
Coordinator
ensuring initial and ongoing consent of study subjects
required to initiate, maintain and close a clinical research trial
but not limited to pre screening potential subjects for clinical
research trials either via phone or in person
sponsor confidential information and company confidential
information
adverse events, serious adverse events, and adverse events of
special interest to the Clinical Research Team
lab equipment areas as needed
records and study related documents as required.
to answering phones, scheduling subjects, making reminder
calls and updating patient tracking systems.
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