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Details
Posted: 03-Jun-22
Location: Boston, Massachusetts
Salary: Open
Internal Number: 65403BR
The Boston Children's Hospital Division of Immunology/Allergy is seeking a full-time, long-term Clinical Trial Manager for a busy NIH funded Asthma/Allergy Clinical Research Center leading state of the art studies on asthma and allergic diseases and interacting with multiple Centers across the country, the NIH and the FDA. The program conducts state-of-the-art Pediatric studies with up to 13 national sites and a centralized Data Coordinating Center. The Center also conducts community studies focused on mechanisms and environmental interventions to reduce health disparities.
This Clinical Research Manager will be responsible for:
- Under minimal supervision and in accordance with established protocols, coordinates daily operations of research studies.
- Responsibilities include: initiating start up activities, supervising and hiring research staff, liaison with other health care providers, recruitment of patients for enrollment in clinical trials, organizing strategies for recruiting study patients, screening patients for eligibility, and following up with patients.
- You will coordinate and conduct all Boston-based clinical research activities and serve as a liason in operations with the other national Clinical Asthma Research sites and the Data Coordinating Center and manage big studies.
- This manager will primarily work with the pediatric trials and associated staff and investigators.
- Training as necessary will be done in asthma/allergy related clinical research procedures such as pulmonary function testing, allergen skin testing, methacholine challenge testing, and induced sputum procedures and previous experience is a plus.
- Spanish speaking skills also a plus. Enthusiasm required. You will supervise staff and assist in conducting these procedures and all activities related to the clinical research study visits and data collection.
- You will work closely with the PI on all clinical research activities and procedures and manage the team and all interactions with the NIH, regulatory agents and the FDA.
- In addition, duties will include preparation of protocol applications, maintaining regulatory binders, case report forms, source documents, data management, and other study documents as well as monitoring and reporting the occurrence of clinical adverse events.
- Maintain and update information as required by Hospital and Sponsor/NIH guidelines subject to external monitoring by regulatory agencies.
- Efficient use of resources and understanding of NIH budgets and fiscal management is also a plus.
- Bachelor's and Masters or Advanced degree required. Strong interpersonal skills and ability to multi-task required.
- Minimum 10 years full time, relevant clinical research experience required.
- Previous experience in clinical work and other medical related fields including respiratory therapy, pulmonary function/ allergy asthma medical fields with clinical research experience strongly encouraged to apply.
- Commitment to the program is required.
- Previous management experience preferred.
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.
More Jobs from This Employer
https://careers.chpa.org/jobs/16908966/clinical-research-manager-i-allergy-asthma
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