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.
The Clinical Research Specialist I will be responsible for:
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.
Communication skills to effectively deal with conflicting views or issues and mediate fair solutions, and well-developed writing 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 offers competitive compensation and unmatched benefits, including affordable health, vision and dental insurance, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition Reimbursement, and discounted rates on T-passes (50% off). Discover your best.
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: 3097651
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.