Clinical Research Coordinator 1

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The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Clinical Research Coordinator to work at the UHealth medical campus in Miami, Fl.

CORE SUMMARY:

The Clinical Research Coordinator (CRC) will assist the Principal Investigator in the conduct all aspects of the clinical trial, including regulatory tasks, under the direct supervision of the Principal Investigator, and Clinical Research Manager.  The CRC provides operational and administrative support in the management of patients accrued to multiple research protocols to assure subjects’ safety and regulatory compliance.  The CRC is responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, Standard Operating Procedures and all applicable regulations and guidelines and ensuring effective data flow associated with research protocols.

The CRC is critical to ensuring the safety of patients enrolled on a clinical trial. Patient duties include but are not limited to:

Meeting with the patient in clinic and providing information on the specific clinical trial; answering the patient questions and facilitating the informed consent process Providing the patient a point of contact for all clinical trial questions or concerns Being available and present in clinic and in the Chemotherapy Treatment Unit when the patient is dosed Meeting the patient in clinic for all visits during treatment and follow up to ensure the patient is fully informed and any questions or concerns addressed Being available in the clinic to the physician and the patient to ensure protocol compliance and source data is documented appropriately and according to Good Clinical Practice Attending clinic at the time of the patient visit to ensure all adverse event documentation and concomitant medication information is documented according to the protocol requirements Ensuring all patient protocol appointments are scheduled as required

CORE JOB DUTIES & RESPONSIBLITIES:

• Assists the Monitors and PIs in the organization and preparation of Site Initiation Visits (SIV) and in providing the patients and their families with a thorough description of the research protocol.
• Attends site disease group tumor board meetings and site disease group collaborative meetings.
• Assures that all protocol revisions, informed consents, continuing reviews, serious adverse events are submitted to the appropriate IRB of record in a timely manner.
• Compiles patient data and presents those to the PI for their determination of patient eligibility for protocol enrollment.  Ensures eligibility forms are completed as required.
• Assists PI in obtaining informed consent and documents the informed consent process as required.  Enters required protocol enrollment report to CRIS Office and JHS CTO according to established procedures.  Complete sand submits to the CRIS Office and/or JHS CTO Office protocol specific forms as required per UM and/or JHS policies.
• Ensures study protocol adherence, including completion of protocol specific procedures and the completion of protocol specific documents while obtaining relevant medical information from patient clinic charts/medical records.  
• Establishes and maintains contact with patients/participants, health care providers, community agencies, study sponsors.  Updates appropriate agencies such as sponsors, IRB, etc. regarding current status of research projects as required and under the supervision of the PI.
• Maintains /logs progress reports to track both currently enrolled as well as follow-up participants. 
• Provides protocol specific study documentation required in the management of study patients as per the protocol, federal regulations, sponsor requirements, SOPs and UM policies while maintaining logs to track progress reports to both currently enrolled as well as follow-up participants. 
• Enters data onto case report forms and/or into computer database. Completes corrections/queries required at audits/monitor visits in a timely manner. Ensures data integrity and consistency in computer database and written records by reviewing entered data for accuracy.
• Execute the plan developed for colle