Boston Children’s Hospital
Clinical Research Assistant I
Boston Children’s Hospital, Boston, Massachusetts, us, 02298
The Department of Cardiology at Boston Children’s Hospital and Harvard Medical School is seeking a Clinical Research Assistant to join the Electrocardiogram Core Laboratory for two multicenter studies.
The Clinical Research Assistant will help coordinate daily operations including coordination with sites for ECG transfer, ECG tracking and reporting of results. In addition, the Research Assistant will take an active part in ILR for an interstage monitoring study. This is a prospective clinical trial evaluating the use of a monitoring device in patients with a single ventricle, performed under an investigational device exemption regulated by the FDA.
There will also be opportunities for participation in various single and multi-center efforts related to electrophysiology and pediatric cardiology. The Research Assistant will have opportunities to be included in the publication of manuscripts. This is a two-year position aimed at providing the Research Assistant with the skills and experience to further their career in medicine.
Primary Responsibilities:
Screening and consenting patients through personal interviews and written communications with patients/families.Data collection through medical record review.Contributing data to the existing databases.Submission of new research protocols to the scientific review committee and IRB.Maintenance of regulatory documents (IRB, FDA).Literature reviews.Coordination of team meetings (including agenda creation and summary documents).
Additional Responsibilities:
Provides detailed background information regarding studies to families, communicates all policies and procedures, and responds to all inquiries.Evaluates suitability of prospective study candidates and makes selections based upon clinical knowledge of each study.Serves as liaison to the families/patients in the research studies, conducted at both on-site and off-site locations, guiding and advising them throughout each phase of the study.Acts as a resource to study participants, addressing any concerns they may have and troubleshooting resolution of any issues that may arise throughout the study.Coordinates and prepares the necessary documentation for Institutional Review Board (IRB) and Committee on Clinical Investigations (CCI) submissions, together with the Principal Investigator of the study.Creates and prepares data collection statistical reports and analytical summaries for distribution to the study research team for review and analysis.Writes articles and summary papers of studies for submission to medical journals, as may be necessary/requested.Participates in the training of newly hired research study assistants, as required.Communicates project policies and procedures to personnel.Monitors and reviews data collection and data entry, and informed consent procedures ensuring consistency of application for each study.Requirements:
A Bachelor’s degree is required; a background in university-level science courses is preferred.Research skills and the ability to work independently are essential.Excellent organizational and communication skills, and the ability to keep meticulous records are required.Please include a cover letter with your resume.
Knowledge, Skills and Abilities:
Analytical skills to gather and interpret data in which the information or problems are moderately complex to complex.Advanced writing skills.
Boston Children’s Hospital offers competitive compensation and unmatched benefits.
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The Clinical Research Assistant will help coordinate daily operations including coordination with sites for ECG transfer, ECG tracking and reporting of results. In addition, the Research Assistant will take an active part in ILR for an interstage monitoring study. This is a prospective clinical trial evaluating the use of a monitoring device in patients with a single ventricle, performed under an investigational device exemption regulated by the FDA.
There will also be opportunities for participation in various single and multi-center efforts related to electrophysiology and pediatric cardiology. The Research Assistant will have opportunities to be included in the publication of manuscripts. This is a two-year position aimed at providing the Research Assistant with the skills and experience to further their career in medicine.
Primary Responsibilities:
Screening and consenting patients through personal interviews and written communications with patients/families.Data collection through medical record review.Contributing data to the existing databases.Submission of new research protocols to the scientific review committee and IRB.Maintenance of regulatory documents (IRB, FDA).Literature reviews.Coordination of team meetings (including agenda creation and summary documents).
Additional Responsibilities:
Provides detailed background information regarding studies to families, communicates all policies and procedures, and responds to all inquiries.Evaluates suitability of prospective study candidates and makes selections based upon clinical knowledge of each study.Serves as liaison to the families/patients in the research studies, conducted at both on-site and off-site locations, guiding and advising them throughout each phase of the study.Acts as a resource to study participants, addressing any concerns they may have and troubleshooting resolution of any issues that may arise throughout the study.Coordinates and prepares the necessary documentation for Institutional Review Board (IRB) and Committee on Clinical Investigations (CCI) submissions, together with the Principal Investigator of the study.Creates and prepares data collection statistical reports and analytical summaries for distribution to the study research team for review and analysis.Writes articles and summary papers of studies for submission to medical journals, as may be necessary/requested.Participates in the training of newly hired research study assistants, as required.Communicates project policies and procedures to personnel.Monitors and reviews data collection and data entry, and informed consent procedures ensuring consistency of application for each study.Requirements:
A Bachelor’s degree is required; a background in university-level science courses is preferred.Research skills and the ability to work independently are essential.Excellent organizational and communication skills, and the ability to keep meticulous records are required.Please include a cover letter with your resume.
Knowledge, Skills and Abilities:
Analytical skills to gather and interpret data in which the information or problems are moderately complex to complex.Advanced writing skills.
Boston Children’s Hospital offers competitive compensation and unmatched benefits.
#J-18808-Ljbffr