Boston Children's Hospital's Department of Neurology is seeking a professional, well-organized team player to fill the position of a Clinical Research Specialist 1 in the Department of Neurology's Translational Neuroscience Center.
The selected candidate will assist in managing the operations of the Translational Neuroscience Center's clinical research program, including research and administrative procedures, research participant recruitment and enrollment as well as ensuring compliance with hospital, state, federal and regulatory policies and procedures. This individual would work with Investigators, Managers, and Research Coordinators in designing and implementing clinical trials and other research studies with patients with rare genetic disorders associated autism. Join our expanding program and contribute to local, national and international efforts to improve the lives of children with neurological disorders and the families that care for them. Other responsibilities:
Assisting Principal Investigators (PIs) in planning and implementing clinical research studies as assigned. Coordinating preparation of protocol applications for submission to the IRB, sponsor or regulatory authority. Corresponding with the IRB, study sponsors, clinical research organizations, study participants and referring physicians.
Recruiting study participants for enrollment in clinical trials. Following individual study protocols. Completing informed consent procedures as assigned. Organizing strategies for recruiting study participants, screening study participants for eligibility on the telephone, in the clinic and other settings as required. Completing follow up with study participants in prescribed settings as required.
Organizing study procedures and scheduling study participants for study visits. Assisting the PI during patient visits. Performing study procedures designated for the Study Coordinator.
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.
Complying with all institutional policies and government regulations pertaining to human subjects protections. Maintaining 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. Updating protocol and amendment changes.
Working with study staff to prepare for monitoring and audits of the independent monitor, sponsor and Food and Drug Administration (FDA). Working closely with others in the Clinical Research Program.
Assisting investigators in preparing articles for journal publication. Performing literature searches. Attending applicable courses and meetings offered by Clinical Research Program.
To qualify, you must have:
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 collect information from diverse sources, apply professional principles in performing various analyses, and summarize the information and data to solve problems.
Strong Communication skills.
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: 3112174
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.