At Boston Children's Hospital, success is measured in patients treated, parents comforted and teams taught. It's in discoveries made, processes perfected, and technology advanced. In major medical breakthroughs and small acts of kindness. And in colleagues who have your back and patients who have your heart. As the teaching hospital of Harvard Medical School, our reach is global and our impact is profound. Join our acclaimed Division of Pulmonary Research and discover how your talents can change lives. Yours included.
The Pulmonary Division at BCH is developing an enhanced and reconfigured research infrastructure focused on discovery in the areas of genetics, genomics and regenerative medicine. In this context, we are hiring for an experienced clinical research specialist with strong expertise in IRB/regulatory systems. The Clinical Research Specialist will be joining an innovative research enterprise with experience in translational lung research. Strong clinical research and IRB skills are required.
This Clinical Research Specialist I will be responsible for:
Working closely with Pulmonary PI's and research team on coordinating preparation of protocol applications for submission to the IRB, sponsor or regulatory authority. Corresponding with the IRB, study sponsors, clinical research organizations, study participants and referring physicians.
Maintaining regulatory binders (both paper and electronic), case report forms, source documents, and other study documents. Reporting the occurrence of clinical adverse events, to study PI, the study sponsor, and IRB. Submitting protocol amendments, including all informed consent changes to IRB.
Overseeing development of new electronic web-based regulatory system.
Completing record abstraction of source documents, conducting required study measurements and completing study Case Report Forms in accordance with best practice methods. Completing data entry as needed.
Working with study staff to prepare for monitoring and audits of the independent monitor, sponsor and Food and Drug Administration. Working closely with others in the Clinical Research Program.
Complying with all institutional policies and government regulations pertaining to human subjects protections. Working with staff across the division to ensure regulatory compliance with state and federal guidelines.
To qualify, you must have :
Bachelor's degree and a minimum three years of relevant work experience; or Masters Degree and one year of relevant work experience.
Prior experience in an academic clinical research setting preferred, preferably working in IRB/regulatory systems.
The analytical skills to collect information from diverse sources, apply professional principles in performing various analyses, and summarize the information and data to solve problems.
Excellent communication skills to effectively deal with conflicting views or issues and mediate fair solutions, and well-developed writing skills.
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. *LI
Internal Number: 2849770
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.