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Children's Hospital Boston Clinical Research Assistant II - Progeria Team in Boston, Massachusetts

58426BRTitle:Clinical Research Assistant II - Progeria TeamDepartment:Critical CareAutoReqId:58426BRStatus:Full-TimeStandard Hours per Week:40 Job 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 oversee collection, maintenance and retrieval of study data, and develop/implement systems and procedures to ensure accuracy, consistency and conformance with research protocol requirements. The coordinator will assist study investigators in various study procedures, maintain study documents and patient files, and complete Case Report Forms. The coordinator will interact with research subjects and families during complex clinical trial visits.

​Responsibilities include:

  • Overseeing collection, maintenance and retrieval of study data, procedures to ensure accuracy, consistency and conformance with protocol requirements.

  • Maintaining/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

  • Updating progeria team on CHeRP

  • Preparation of protocol applications for submission to the IRB, sponsor or regulatory authority.

  • Submitting translated consents to IRB for approval

  • Medication Shipment/Inventory

  • Creating medication forecast and determine supply needs on a monthly basis

  • Request medication supply from pharmaceutical company

  • Requesting med orders and sending signed med orders for pharmacy to fill

  • Subject Visit Week

  • Oversee scheduling of patient visit week tests, imaging, meetings etc.

  • Typing up patient visit schedules and sending it to extended progeria team

  • Coordinate subject visit week with PRF coordinator

  • Oversee transport of study samples from CTSU/Trans labs to freezer in Enders

  • Completion and submission of STSs following patient visit week

  • Data entry and oversight

  • Oversee collection/entry/QC of data sets

  • Submission of data to stats/other investigators as needed

  • Management of data electronic drive

  • Fulfilling data requests as needed

  • Interns

  • Assisting with onboarding

  • Overseeing intern training and providing ongoing support and assistance

  • Administrative Duties

  • Patient files (paper/electronic) maintenance

  • Maintain SOP electronic folder – organization and updating/creating SOPs as needed

  • Updating master sheet and study inclusion diagram

  • Ordering research tubes for subject visit week

  • Composing and sending out data meeting, monthly meeting, and CVNV agenda’s

  • Typing up minutes for CVNV and Stats meetings

  • Research samples and Freezer

  • Overseeing and updating freezer sample inventory

  • Coordination transfer of samples to Brown and CROs

  • Creating and maintaining inventory of all research samples collected

  • Collection, processing and/or delivery of study specimens to appropriate labs or packaging and shipping to appropriate facilities.

  • Complying with all institutional policies and government regulations pertaining to human subjects protections

  • Completing record abstraction of source documents, conducting required study measurements and completing study Case Report Forms.

  • Conducting periodic testing of data validity, identifying and resolving any errors or discrepancies.

    To qualify, you must have:

  • The knowledge of theories, principles, and concepts acquired through completion of a Bachelor's degree in a related science and one year of related work experience.

    Please note: During a public health emergency, individuals in this role may be expected to take on additional duties to respond to organizational needs.

BCH offers competitive compensation and benefits.

Boston Children’s Hospital is an Equal Opportunity / Affirmative Action Employer. Qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, sex, sexual orientation, gender identity, protected veteran status or disability.

Office/Site Location:BostonRegular, Temporary, Per Diem:Regular