Research Specialist-EPID

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For positions that have only a rate listed, the displayed rate is the hiring rate but could be subject to change based on shift differential, experience, education or other relevant factors.

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• Coordinate follow-up patient/subject visits, tests and procedures as per request of Physician. Percentage of time: 20%
  * Patients are scheduled on a timely basis according to protocol. Provide clear and accurate direction to patient and parent. Communication of progress with research team is maintained
  Conduct required data entry Percentage of time: 15%
  * 100% accuracy and high quality data collected and submitted in research database
  Assists Research Assistant with day to day management of Clinical Trials Percentage of time : 15%
  * Ensure adherence to study protocols and IRB regulations
  Maintain subject charts and database and reports adverse events according to defined standards Percentage of time: 10%
  * Prepares and presents data for analysis and interpretation by Principal Investigator an/or research team. Expect 100% compliance with pertinent regulations
  Assists Principal Investigator (PI) and research team with development of research protocols and grant writing Percentage of time: 10%
  * Provides creative and administrative support during grant and clinical research protocol writing process.
  Educate patients and parents about the study Percentage of time: 5%
  * Patient and parent(s) have complete understanding of study requirements, expectations, risks and potential benefits
  Perform informed consent process in a manner consistent with legal and ethical standards Percentage of time: 5%
  * Zero tolerance for deviation from full adherence to good clinical practice guidelines and accuracy of data collection
• Assure that study patients who are recruited into the study are eligible and have received informed consent, as per IRB regulations Percentage of time: 3%
  * Successful patient recruitment as per study protocol
  Responsible for fulfilling regulatory requirements as set forth by IRB and GCP including but not limited to: completing registration forms of patients on study, preparing progress reports and renewal applications, and keeping records of amendments Percentage of time: 5%
  * Meets IRB deadlines, keep meticulous research records, follows IRB guidelines exactly. 100% accuracy
  Develops work flow policies and procedures, prepares manuals and documents related to operations of the function Percentage of time: 5%
  * Policies and procedures are discussed with team and approved by Division chief
  Participates in grant related meetings with Principal Investigator and/or Research team.
  Percentage of time: 5 %
  * Protocol issues and project developments are discussed with PI and research team.
  Prompt and effective communication with investigators and other participants of the study program team regarding patient study issues.
  * Prompt reporting of any identified issues affecting patient safety and/or study guidelines
  Perform clerical and secretarial tasks as required and relevant to clinical research work. This will include shipping of samples. 2%
  * Timely completion of tasks in order to meet department needs
  Practices Monte Excellence Standards (R-E-S-P-E-C-T)
  * Demonstrates Monte Excellence standards in all encounters

• BS Required
• MS Preferred
• 1-3 years Previous experience working with Clinical Trials, GCP guidelines, Completion of CITI course
• 1-3 years Clinical Trials or Clinical Research experience
• Experience working in a hospital setting
• Experience with industry sponsored trials
• Experience with IRB protocol submissions
• Proficiency with computer and data entry required, including Microsoft Office Suite, and familiarity with electronic data registries.
• Excellent communication and coordinating skills necessary.
• Ability to work independently as well as ability to work as a team member.
• OHS Annual Assessment
• OHS Fit Test