Essential Job functions:

• Together with Research Team and Research Review Committee, work with industry sponsor and physicians to identify appropriate protocols.
• Daily review of physician schedules for new diagnosis, change in diagnosis/treatment for entry onto oncology patient tracker.
• Assist in completion of completion of study start up and ongoing documents, including IRB submission.
• Coordinate and facilitate site qualification visits.* Assist in evaluation of all potential clinical research studies.
• Exhibit working knowledge of protocol(s), including objectives, rationale, and description of investigational product, inclusion/exclusion criteria, study visits and procedures, concomitant medications.
• Communicates with sponsor to assure receipt of necessary study supplies (i.e., lab kits, CRFs, tools, investigational product, binders…), documents and maintains logs.
• Identifies study specific lab and ancillary procedures, contacts appropriate personnel within each department, facilitates training, certification, validation/calibration, and establishes workflow(s).
• Assemble and maintain source document binders assuring the most current version of informed consent is available.
• Prepare and distribute study related advertisements/recruitment materials (i.e., brochures, flyers, screening worksheets, physician-to-physician letters, Sound-card).
• Screen patients in appropriate departments and via data base query, if applicable, documents screening efforts and enters information as per protocol requirements.
• Maintain communication and visibility with investigators and support staff to promote and encourage patient enrollment.
• Enroll patients as per protocol.
• Submit documents to sponsor, CRO and/or IRB.
• File regulatory documents, correspondence and communication approximately in a timely manner.
• Schedule/order patient visits accurately: informed consent discussion, investigator visits, lab, and ancillary as per protocol.
• Promotes protocol compliance by being available at all patient visits.
• Ensures study documentation is complete and accurate; completes CRFs/EDC at time of enrollments and all subsequent visits within 5 days of visit.
• Responds to queries/data clarifications adequately and within 5 days of receipt.
• Maintains minimum amount of queries/data clarifications.
• Ensures investigator receives reviews and signs all lab and ancillary tests within 48 hours of receipt.
• Follow enrolled patient for duration of study and ensure follow-up visits, labs, ancillary testing is complete.
• Together with licensed clinical research coordinator and investigator, monitor for adverse events/serious adverse events. Notify licensed clinical research coordinator and investigator immediately of any adverse event/serious adverse event. Notify sponsor/IRB as per protocol requirements. Assure accurate and timely documentation of any adverse event/serious adverse event.
• Coordinate monitor visits, ensure all source data is complete, accurate and signed and all CRFs/EDC are complete, all queries/data clarifications have been responded to.
• Available at all times during monitor visits for clarification and corrections.
• Knowledge of and works within guidelines of ICH/GCP and FDA regulations.
• Ensures all regulatory documents are filed in appropriate binder and correspondence/forms are submitted in timely manner; files regulatory documents within 5 days of receipt; maintains neat and orderly binders.
• Prepares patient for investigator visit by obtaining medical history, concomitant medications, vital signs, questionnaires, lab/diagnostic results, and change in health status.
• Able to complete IATA training and lab specimen shipping.