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.
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
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
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
Assisting with onboarding
Overseeing intern training and providing ongoing support and assistance
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.
Internal Number: 3132229
About Boston Children's Hospital
Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care. As one of the largest pediatric medical centers in the United States, Children's offers a complete range of health care services for children from birth through 21 years of age.