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 a teaching hospital of Harvard Medical School, our reach is global and our impact is profound. Join our acclaimed Vascular Anomalies Center and discover how your talents can change lives. Yours included.
Principal Duties and Responsibilities of a Clinical Research Manager II:
The Clinical Research Manager II within the Vascular Anomalies program is responsible for the oversight of the programs clinical research portfolio and all related regulatory, compliance and performance metrics requirements.
The CRM II will oversee the processing of protocols through BCH Institutional Review Board (and other institutions' IRBs) when appropriate.
The CRM II will identify and manage operational, logistical, and regulatory challenges related to the conduct of clinical trials and acts as a leader in overseeing their resolution.
The CRM II will assist the principal investigator in developing the protocol budget, in collaboration with the Clinical Trials Business Office. Work with grant managers and other financial managers in the reporting and accounting of these funds.
Leads and manages the work of multiple clinical research projects. Serves as Clinical Research Study/Trial Manager for one or more large, clinical studies.
Collaborates and consults with investigators and their staff on the design, development, and conduct of clinical research studies and on clinical research best practices.
Works with study investigators and statisticians to plan analyses, clean and verify data and facilitate preparation of datasets for analyses.
Collaborates directly with Hospital investigators and scientific staff on developing and writing grants and study protocols.
Develops curriculum, conducts lectures, and directs courses as part of sponsored educational efforts to train clinical investigators and study staff in clinical research regulations and best practices.
Leads design and development of data management and data monitoring tools and procedures and supervises data management staff and activities in compliance with GCP and program standards.
Lead and collaborates with matrix team to design and develop study databases and related products and procedures. Manages staff's performance reviews.
Ensures work is performed in conformance with established hospital, program, federal, and state policies and procedures.
Knowledgeable and experience in regulatory matters: preparation of IRB applications, amendment submissions, and annual reporting.
Knowledge and experience in navigating FDA regulated studies.
Bachelor's degree and a minimum of 8 years of relevant work experience or Master of Science and 6 yrs of relevant work experience.
Previous work with Pediatric Patients preferred.
Please note: 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, including 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 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: 3143939
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.