Children's Hospital Boston Clinical Research Specialist I in Boston, Massachusetts
Title Clinical Research Specialist I
Department Orthopedic Surgery & Research
Job Posting Description At Boston Children’s Hospital, success is measured in patients treated, parents comforted and teams taught. It’s in discoveries made, processes perfected, and technology advanced. In major medical breakthroughs and small acts of kindness. And in colleagues who have your back and patients who have your heart. As the teaching hospital of Harvard Medical School, our reach is global and our impact is profound. Join our acclaimed Division of Orthopedic Surgery & Research and discover how your talents 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 as warranted.
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 (IRB). Updating protocol and amendment changes.
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 in order to solve problems.
Communication skills in order to effectively deal with conflicting views or issues and mediate fair solutions, and well-developed writing skills. Effective communication skills with parents/study participants in order to explain the research protocol, to obtain informed consent, to obtain accurate information from them, and to provide them with accurate information.
Boston Children’s Hospital offers competitive compensation and unmatched benefits, including a rotating days/evenings and week-end schedule, affordable health, vision and dental insurance, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition Reimbursement, cell phone plan discounts 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.
Status Full Time
Schedule (i.e. Mon. - Fri.) Mon- Fri
Standard Hours per Week 40