MCR803 Final Fall Exam

The purpose of this course was to have you learn and understand the requirements for the successful conduct of clinical research from the perspective of a Clinical Research Coordinator (CRC) at a research site. Complete this Final Exam as follows:

  1. The first column in the table below contains the individual responsibilities of a CRC at the Dana-Farber Cancer Institute (DFCI)
  2. For each of the individual responsibilities, you are to create one (1) key question that a hiring manager would ask during a face-to-face interview
  3. For each of the key questions, you need to provide an accurate and detailed response from the person being interviewed
  4. REMEMBER – this Final Exam is worth a total of 140 points (7 points for each of the 20 rows) – the rows are expandable to accommodate any length of response. Expectations are that you identify a specific key question that, if answered correctly, will clearly demonstrate that the job applicant knows what they are talking about. Therefore, your key question should not be simply. “So tell me how you would…”
  5. Finally, save a copy of your completed exam, as it will be useful some day in the future if you interview for a CRC position.

Job Responsibility from DFCI Position DescriptionKey Question to be Posed by InterviewerResponse by Interviewee
“support the research team in the overall conduct of clinical trials using GCP”  
“responsible for the primary data collection of patient clinical information as it pertains to participation in clinical trials”  
“responsible for the management of patient clinical information as it pertains to participation in clinical trials”  
“Ensures timely collection of protocol related samples including shipment to outside entities as required”  
“Maintains regulatory binders in compliance with all state, federal, and IRB requirements”  
“Ensures study compliance with all state, federal, and IRB requirements”  
“May be responsible for IRB protocol submissions (amendments, continuing reviews, and minimal risk protocols)”  
“This individual may also screen patients for protocol eligibility, obtain informed consent, and register study participants to clinical trials”  
“Oversight of the clinical trials start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities”  
“Responsible for data reporting and management”  
“Responsible for collection of source documents”  
“Responsible for adverse events reporting”  
“Responsible for filing and archiving of study records”  
“Responsible for resolution of data queries”  
“Prepare and or complete regulatory related reports and IRB submissions”  
“Ensure all study related samples are collected, properly prepared and shipped according to the protocol requirements and IATA/DOT regulations”  
“Responsible for organizing and preparing for both internal and external auditing and study monitoring visits”  
“Coordination and management of clinical trials, including communication with Sponsors and regulatory authorities”  
“Close-out of clinical trials, including contributing to research articles, audit preparation, and communication with regulatory agencies and other disciplines involved”  
“Interact with study participants as directed/required by the protocol and/or study team”  

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