Children's Hospital Boston Clinical Research Specialist I in Boston, Massachusetts
46668BRTitle:Clinical Research Specialist IDepartment:Orthopedic Surgery & ResearchAutoReqId:46668BRStatus:Full Time Standard Hours per Week:40 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 a teaching hospital of Harvard Medical School, our reach is global and our impact is profound. Join our acclaimed Department of Orthopedic Research and discover how your talents can change lives. Yours included.
The Clinical Research Specialist II 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 or Master’s degree in a scientific or health related field and 3-5 years experience (BA/BS degree) or 1–2 years experience (Master’s Degree) as a clinical research coordinator; requires proven ability to work independently.
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.
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 Savingsplan, 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.Office/Site Location:Boston