At Boston Children's Hospital, the quality of our care - and our inclusive hospital working environment - lies in the diversity of our people. With patients from local communities and 160 countries around the world, we're committed to reflecting the spectrum of their cultures, while opening doors of opportunity for our team. Here, different talents pursue common goals. Voices are heard and ideas are shared. Join us, and discover how your unique contributions can change lives. Yours included. This Clinical Research Specialist I will be responsible for:
Assisting Principal Investigator (PI) Dr. Adrienne Randolph in planning and implementing clinical research studies on severe acute infections in children and their complications including influenza and COVID-19 for the Overcoming COVID-19 study (overcomecovid.org) and the Pediatric Intensive Care Influenza (PICFLU) Network (PICFLU.org).
Under the direction of the PI and Program Manager coordinates preparation of protocol applications for submission to the IRB and manages site IRB-related issues, and site-related sponsor or regulatory authority issues (CDC, NIH). As directed by the PI corresponds with the IRB, study sponsors, clinical research organizations, study participants and referring physicians.
Recruiting study participants for enrollment in clinical studies. Follows individual study protocols. Completes informed consent procedures as assigned. Organizes strategies for recruiting study participants, screens study participants for eligibility using data in the clinical chart and from bedside providers. Oversees blood and respiratory sample collection and transfer of samples to Dr. Randolph's Immunobiology of Critical Illness laboratory. Completing follow up with study participants in prescribed settings as required.
Organizing study procedures and scheduling study participants for enrolled patients. Assisting the PI during patient enrollment and follow up. Performs study procedures designated for the Study Coordinator.
Assists the Program Manager aning PI in multicenter study activities. These include data cleaning, confirmation of data completion, site invoice approval-tracking-submission, development of training materials, and scheduling of meetings.
Completing record abstraction of source documents, conducting required study measurements and completing study Case Report Forms in accordance with best practice methods. Conducting a QC check of completed CRFs prior to submission for data entry; coordinating resolution of all data queries. Completing data entry as warranted.
Complying with all institutional policies and government regulations pertaining to human subject's protections. Maintains regulatory binders, case report forms, source documents, and other study documents. Monitoring the occurrence of clinical adverse events, reporting any to the (PI), the study sponsor and Committee on Clinical Investigations (IRB). Updating protocol and amendment changes.
Assisting investigators in data and/or document preparation for journal publication. Performs literature searches and pulls articles. Evaluating data from REDCap database extractions. Developing figures and tables for publications.
To qualify, you must have:
Bachelor's degree, and a minimum 3 years of relevant work experience or Masters of Science and one year of relevant 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. 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: 3056027
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.