Clinical Research Specialist I

Position Summary
This Clinical Research Specialist will support clinical research in rare genetic conditions by facilitating online enrollment, online, remote and in person data collection, collection of medical records, and collection of biospecimens from patients around the world with rare genetic conditions we study in Wendy Chung's lab. Collection and analysis of these data will help us characterize these new genetic conditions and design clinical trials to test new treatments and interventions to treat these conditions. These rare genetic conditions include conditions that affect neurodevelopment, behavior including autism, structural congenital anomalies, pulmonary hypertension, and cardiomyopathies. The research coordinator will work with a team of physicians, scientists, genetic counselors, and nurses working together with rare diseases patient advocacy groups to better understand these rare genetic conditions.

Key Responsibilities

• Assists 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.
• Recruits study participants for enrollment in clinical trials. Follows individual study protocols. Completes informed consent procedures as assigned. Organizes strategies for recruiting study participants and 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.
• Organizes study procedures and schedules study participants for study visits. Assists the PI during patient visits. Performs study procedures designated for the Study Coordinator.
• Completes 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.
• Complies 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.
• Assists investigators in data and/or document preparation for journal publication. Performs literature searches and pulls articles.

Minimum Qualifications
Education:

• Bachelor's degree and 3 years of relevant work experience OR Master's degree and 1 year of relevant work experience

Experience:

• 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.

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.