Clinical Research Study Coordinator
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 shall be responsible for:
- Assisting Principal Investigators (PIs) in planning and implementing clinical research studies as assigned. Under the direction of the PI coordinates preparation of protocol applications for submission to the IRB, sponsor or regulatory authority. As directed by the PI corresponds with the IRB, study sponsors, clinical research organizations, study participants and referring physicians.
- Recruiting study participants for enrollment in clinical trials. Follows individual study protocols. Completing informed consent procedures as assigned. Organizing strategies for recruiting study participants, screens 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. Performs study procedures designated for the Study Coordinator.
- Completing record abstraction of source documents, conducts 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; coordinates 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). Updates protocol and amendment changes.
- Assisting investigators in data and/or document preparation for journal publication. Performs literature searches and pulls articles.
In order to qualify you must have:
- A Bachelor's degree, and a minimum three years of relevant work experience or Masters of Science and one year of relevant work experience.
- Analytical skills to gather and interpret data in which the information or problems are complex.
- Well-developed communication skills in order to provide critical information to patients, effectively deal with conflicting views or issues, and the ability to mediate fair solutions. Work also requires advanced 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.
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.