At Boston Children's Hospital, success is measured in patients treated, parents comforted and teams taught. As a teaching hospital of Harvard Medical School, our reach is global and our impact is profound. Join our acclaimed Division of Genetics and Genomics and discover how your talents can change lives.
The clinical research group within the Division of Genetics and Genomics is looking for an experienced coordinator to join our multidisciplinary research team. The coordinator would assist with the daily operations of a variety of cutting edge rare disease clinical trials (all phases), including scheduling and running study visits, handling and shipping laboratory samples, entering data, invoicing, assisting with IRB submissions and regulatory binder maintenance. Excellent written and oral communication skills as well as attention to detail are a must. A 2 year commitment is required.
This Clinical Research Specialist I will be responsible for:
Assisting Principal Investigators (PIs) in planning and implementing clinical research studies as assigned. Under the direction of the PI coordinating preparation of protocol applications for submission to the IRB, sponsor or regulatory authority. As directed by the PI 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 schedules 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 completes 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.
Compiling 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.
Assisting investigators in data and/or document preparation for journal publication. Performing literature searches and pulling articles.
To qualify, you must have:
The knowledge of theories, principles, and concepts acquired through completion of a Bachelor's degree, and a minimum three years of relevant work experience or Masters of Science and one year of relevant work experience.
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).
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: 2996299
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.