At Boston Children's Hospital, success is measured in patients treated, parents comforted and teams taught. Dr. Lynda C. Schneider, Professor of Pediatrics at Harvard Medical School and Director of the Allergy/Immunology Clinical Research Program at Boston Children's Hospital, is seeking a Clinical Research Specialist I to start in March of 2019 for her investigative work in the Department of Allergy & Immunology. The Clinical Research Specialist I will assist Dr. Schneider and other research team members in study procedures. The Research Specialist will coordinate multiple allergy studies, including trials of a peanut patch, long-term follow-up for peanut oral immunotherapy and new therapies for atopic dermatitis.
This Clinical Research Specialist I will be responsible for:
Assisting Principal Investigators (PIs) in planning and implementing clinical research studies as assigned. Under the direction of the PI coordinates preparation of protocol applications for submission to the IRB, sponsor or regulatory authority. 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 trials. Follows individual study protocols. Completes informed consent procedures as assigned. Organizes strategies for recruiting study participants, screens study participants for eligibility on the telephone, in the clinic and other settings as required. Completes follow up with study participants in prescribed settings as required.
Organizing study procedures and schedules study participants for study visits. Assists the PI during patient visits. Performs study procedures designated for the Study Coordinator.
Completing record abstraction of source documents, conducts required study measurements and completes study Case Report Forms in accordance with best practice methods. Conducts a QC check of completed CRFs prior to submission for data entry; coordinates resolution of all data queries. Completes data entry as warranted.
Complying with all institutional policies and government regulations pertaining to human subjects protections. Maintains regulatory binders, case report forms, source documents, and other study documents. Monitors the occurrence of clinical adverse events, reporting any to the (PI), the study sponsor and Committee on Clinical Investigations (IRB). Updates protocol and amendment changes.
Assisting investigators in data and/or document prepraration for journal publication. Performs literature searches and pulls articles.
To qualify, you must have:
The knowledge of theories, principles, and concepts acquired through completion of a Bachelor's degree, and a minimum three years of relevant work experience or Masters of Science and one year of relevant work experience.
The analytical skills to gather and interpret data in which the information or problems are moderately complex to complex.
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.
Advanced writing skills.
Highly desirable for eligible candidates to be able to give a two-year commitment.
Boston Children's Hospital offers competitive compensation and unmatched 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: 2801846
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.