Job Summary The IRB Analyst coordinates and implements the daily activities of the Institutional Review Board IRB to ensure Hospital compliance with all applicable state and federal regulations for the protection of human subjects participating in clinical research. Develops, participates in, coordinates and directs education, training and quality improvement activities for human subject protection program.
Principal Duties & Responsibilities:
Under limited supervision coordinates and implements the daily activities of the IRB for all assigned departments.
Reviews incoming protocols emergency requests, amendments and revisions for completeness and compliance with committee standards.
Serves as an independent resource to investigators, responding to questions on preparing and submitting applications and reviewing policies and procedures.
Meets with investigators research coordinators, departmental administrators, managers, scientific review coordinators and other ancillary review representative's clinical trials office, radiation safety, general counsel etc. to educate and advise them on planned protocol submissions.
Prepares report of actions and final approval notices and associated documentation. Assists in developing, recommending and implementing policies and procedures to enhance efficiency of committee operations.
Supports the Manager and Director on other issues pertinent to the implementation of human subject regulations.
Oversees the maintenance of manual and automated record keeping systems to monitor scheduled reviews of human subject protocols.
Notifies investigators of pending reviews, receives, reviews and screens returned forms and documentation.
Follows up with investigators to obtain missing reports or information.
Participates in developing and implementing the educational program for the teaching of research ethics and investigator responsibilities to staff and clinical research personnel at the Hospital.
In coordination with the Manager Director and Team leader, plays active role in the human research protection program including revising policies and procedures and proposing and testing revisions to IRB protocol workflow and record keeping systems.
At discretion of Manager and Director participates in special projects as assigned Provides positive and effective customer service that supports departmental and hospital operation.
Represents the Hospital and the IRB to external clients including other local research institutions, Harvard teaching hospitals.
Work requires a Bachelor's degree and at least 4 years of administrative experience in an IRB setting.
Knowledge of research administration, institutional review boards, or human subject protections required.
Work requires the analytical skills to resolve complex problems requiring the use of scientific, mathematical, or technical principles and in‑depth, experience‑based cross‑functional knowledge.
Work requires the ability to communicate effectively both orally and in writing and provide empathy in difficult interpersonal situations.
Certified IRB Professional (CIP) certification preferred
Boston Children's Hospital offers competitive compensation and unmatched benefits, including a flexible schedule, affordable health, vision and dental insurance, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition Reimbursement, and discounted rates on T-passes (50% off). Discover your best.
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.