Clinical Research Specialist I
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.
Job Summary
As part of the Simons Searchlight research program, this position’s primary role will be to engage and support a research community of individuals with genetic variants associated with autism spectrum disorder and other neurodevelopmental disorders. The Clinical Research Specialist I will work closely with the communications outreach manager in day-to-day management and oversight of communications with all genetic groups in support of initial recruitment, long-term retention and engagement in research. The Clinical Research Specialist I will act as the primary point of contact for patient advocacy groups planning virtual or in-person conferences and for coordinating internal team activities. This position will assist in developing and executing a detailed and substantive recruitment and engagement plan across website, social media and print channels.
This Clinical Research Specialist I will be responsible for:
- Assists 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.
- Recruits study participants for enrollment in clinical trials. Follows individual study protocols. Completes informed consent procedures as assigned. Organizes strategies for recruiting study participants, screens study participants for eligibility on the telephone, in the clinic and other settings as required. Completes follow up with study participants in prescribed settings as required.
- Organizes study procedures and schedules study participants for study visits. Assists the PI during patient visits. Performs study procedures designated for the Study Coordinator.
- Completes record abstraction of source documents, conducts required study measurements and completes study Case Report Forms in accordance with best practice methods. Conducts a QC check of completed CRFs prior to submission for data entry; coordinates resolution of all data queries. Completes data entry as warranted.
- Complies with all institutional policies and government regulations pertaining to human subjects protections. Maintains regulatory binders, case report forms, source documents, and other study documents. Monitors 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.
- Assists investigators in data and/or document preparation for journal publication. Performs literature searches and pulls articles.
In order to qualify, you must have:
- Theories, principles, and concepts acquired through completion of a Bachelor’s degree and minimum three years of relevant work experience OR Masters of Science and one year of relevant work experience.
- Work requires the analytical skills to gather and interpret data in which the information or problems are moderately complex to complex.
- Work requires 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.
Boston Children’s Hospital offers competitive compensation and unmatched benefits including flexible schedules, affordable health, vision and dental insurance, child care and student loan subsidies, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition and certain License and Certification Reimbursement, cell phone plan discounts and discounted rates on T-passes. Experience the benefits of passion and teamwork.
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.