Position: Other Employer: Stanford University Location: 450 Serra Mall, 94305 Stanford, California, United States of America (USA)
The Department of Medicine has an opening for a full-time (100% FTE) Clinical Research Coordinator (CRC). The CRC will be handling management and coordination of an assigned set of research
protocols to assure efficiency and regulatory compliance. S/he will support the Principal Investigator and supervise the study team assigned to the trial. Responsibilities include initiating and
maintaining current and accurate protocols involved in the implementation of clinical trials in critically ill patients. The position requires clinical trial experience and knowledge of patients in
acute care settings. Critical care experience is strongly encouraged. The position is full-time but will not be M-F, 9 to 5. The position provides/requires flexibility of work hours. Some days may
only require a few hours of screening and record keeping but candidates must be available after hours or on weekends as dictated by timing of patient eligibility.
Duties include the following:
Administer Protocols involving studies in patients with medical/surgical history, admitted to hospital. Comprehend study design and implementation and coordinate protocol activities.
Patient screening for evaluation and entry into study. Thorough review and interpretation of patient’s charts and medical history. Interaction with patient’s treating physician to establish
Obtain Consent of Patient or appropriate surrogate decision maker.
Maintenance of study protocol once consent has been obtained patient has been enrolled in the study protocol, including being randomized and treated. Follow patient for signs of adverse events
and report accordingly. Follow up if patient is transferred to another hospital. Handle laboratory specimens for shipping.
Completion of Case Report Forms (CRF) in a timely fashion. Provide source documentation for all study entry, including laboratory, pharmacy and medical record retention.
Maintain proper communication with Institutional Review Board (IRB) regarding Serious Adverse Events (SAE) reporting, protocol violations and amendment reviews and revisions.
Requires Bachelor’s degree (4 year).
Requires at least 1 year as role of study coordinator
Requires ability to comprehend study design/ implement, administer and coordinate protocol activities during standard of care to Intensive Care Unit patients.
Requires strong knowledge of hospital function and care of medical and surgical patients and disease states of HIPAA compliancy during screening process.
Requires knowledge of handling lab specimens for shipping.
Requires knowledge of International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines.
Requires strong interpersonal skills to deal with patient’s critical illness and complex situation, as well as interact with treating physicians, nurses, pharmacy and other health care
Requires knowledge of Institutional Review Board (IRB) policy regarding consenting procedures and be able to maintain proper communication with IRB regarding Serious Adverse Event (SAE)
reporting, protocol violations and amendment reviews and revisions.
Requires ability to provide source documentation for all study entry, including laboratory, pharmacy and medical record retention.
Requires good computer Skills (able to use Microsoft Word and Excel).
Experience in all phases of clinical trials, including Industry, NIH and grants.
Knowledge of illnesses that occur in acute care settings. Critical care experience is strongly encouraged.
Background in medicine or nursing desired
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