Exciting opportunity to join our acclaimed Division of Developmental Medicine and the Translational Neuroscience Center (TNC)-an innovative research collaborative of physicians, genetic counselors and scientists at Boston Children's Hospital. We are seeking a full-time Regulatory Specialist to assist the TNC in gaining a better understanding of childhood health, disease and development. Join us and discover how your talents can change lives. Yours included.
Duties & Responsibilities:
Working closely with the Co-directors of the TNC Clinical Research & Regulatory Affairs Service and investigators from multiple departments/divisions within the hospital to create and maintain essential research procedures and systems.
Providing regulatory guidance to investigators and study staff.
Assisting with consent form development, IRB and FDA applications.
Delivering education to study staff on a variety of topics including good clinical practice, research regulations and the conduct of clinical trials.
Project management and study start up responsibilities for select clinical research projects, including clinical trials.
Providing auditing and monitoring services for research studies as needed.
Assisting with internal and external research collaborations.
A BA/BS degree in health or social science, psychology or related field, with 3 or more years of experience or MS degree with at least 1 years of experience in a public health, community health or clinical research setting. Experience serving as study coordinator or clinical research coordinator desired.
Solid knowledge of clinical research best practices.
Knowledge of human subject protections regulations and FDA regulatory processes.
Ability to work collaboratively with multi-disciplinary project teams.
Ability to communicate effectively both orally and in writing.
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.
Internal Number: 3113358
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.