Job Information
Children's Hospital Boston Clinical Research Assistant II-Progeria Clinical Trials in Boston, Massachusetts
75641BRJob Posting Title:Clinical Research Assistant II-Progeria Clinical TrialsDepartment:Critical CareAutoReqId:75641BRStatus:Full-TimeStandard Hours per Week:40 Job Posting Category:ResearchJob Posting Description:Exciting opportunity to coordinate and manage clinical research as a part of the Progeria Clinical Trials team at Boston Children's Hospital. The coordinator will interact with research subjects and families during complex clinical trial visits and work with our sponsor in all aspects of the study.
This Clinical Research Assistant II will be responsible for:
Consents and recruits patients for research studies through personal interviews and written communications with patients/families. 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.
Maintaining and completing all regulatory documents that include: FDA annual reports, DSMB reports, updating Trial Master File (TMF), memo to files/updating protocol deviation log, reportable events/protocol deviations to IRB, complete queries as needed, and updating progeria team on CheRP.
Preparation of protocol applications for submission to the IRB, sponsor or regulatory authority
Scheduling of patient visit week tests, imaging, specialist meetings, typing up patient visit schedules, coordinate subject visit week with PRF coordinator, and oversee transport of study samples from Experimental Therapeutics Unit (ETU)/Trans lab.
Completion of Oncore and submission of accurate billing following patient visit week.
Responsible for data entry/oversight, collection/entry/QC of data sets, management of electronic data capture (EDC) system, and working with study Sponsor to fulfill data requests as needed
Serves as liaison to the families/patients in the research studies, guiding and advising them throughout each phase of the study. Coordinates follow-up visits as necessary. Acts as a resource to study participants, addressing any concerns they may have. Troubleshoots 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 Principle Investigator (PI) of the study.
Creates and prepares data collection statistical reports and analytical summaries for distribution to study research team for review and analysis. Writes articles and summary papers of studies for submission to medical journals, as may be requested/necessary.
Participates in the training of newly hired research study assistants, as required.
Coordinates activities between the hospital and research laboratories to ensure correct testing/processing and send out instructions specific to the study. 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.
In order to qualify you must have:
A Bachelor's Degree in STEM or Psychology.
Minimum of one year of work experience is required.
Work requires the analytical skills to gather and interpret data in which the information or problems are moderately complex to complex.
Work requires well-developed communication skills in order to provide critical information to patients, effectively deal with conflicting views or issues, and the ability to mediate fair solutions. Work also requires advanced writing skills.
Boston Children’s Hospital offers competitive compensation and unmatched benefits including flexible schedules, affordable health, vision and dental insurance, child care and student loan subsidies, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition and certain License and Certification Reimbursement, cell phone plan discounts and discounted rates on T-passes. Experience the benefits of passion and teamwork.
Office/Site Location:BostonRegular, Temporary, Per Diem:Regular Remote Eligibility :Part Remote/Hybrid