Boston Children's Hospital · 1 day ago
Clinical Research Manager II- Asthma Clinical Research Center
Boston Children's Hospital is seeking a Clinical Research Manager II for their Asthma Clinical Research Center (ACRC). The role involves providing senior-level operational, regulatory, and personnel leadership for a pediatric clinical research program focused on asthma and allergic diseases.
Health CareHospitalMedical
Responsibilities
Manage the daily operations of the Asthma Clinical Research Center (ACRC), ensuring compliance of clinical research activities across multiple concurrent studies
Oversee a diverse portfolio of observational and early-phase, multi-center, federally funded (NIH) and sponsor-initiated clinical trials, including investigator-initiated studies
Provide comprehensive oversight of regulatory, recruitment, and study start-up activities, including IRB submissions, amendments, continuing reviews, and sponsor/NIH communications
Lead, supervise, train, and mentor a team of Clinical Research Assistants, Clinical Research Coordinators, and Clinical Research Specialists, fostering professional development and accountability
Conduct annual performance reviews, goal setting, and ongoing performance management for ACRC research staff
Independently identify and resolve operational, logistical, and regulatory challenges related to complex clinical trials, escalating issues as appropriate and implementing sustainable solutions
Develop and maintain data management, tracking, and monitoring tools in compliance with GCP, NIH requirements, and institutional standards
Manage research staffing budgets and study-level finances in partnership with Principal Investigators and departmental leadership
Oversee operational logistics and infrastructure planning for the ACRC’s clinical research space, including the new research center at 2 Brookline Place
Serve as a key liaison between study teams, hospital departments, sponsors, NIH partners, and external collaborators, ensuring clear communication and timely execution of deliverables
Model and promote the hospital’s core values in all interactions with patients, families, and colleagues
Strong working knowledge of GCP, federal regulations, IRB requirements, and institutional research policies
Qualification
Required
A Bachelor's Degree is required, a Master's Degree is preferred
7 years of relevant post-graduate work experience, including a minimum of two years of managerial experience OR Master's Degree and 5 years of relevant post-graduate work experience, including two years of managerial experience
Demonstrated experience managing early-phase and/or multi-center clinical trials, preferably federally funded (e.g., NIH)
Proven ability to manage multiple complex projects and competing deadlines simultaneously
Experience supervising and developing clinical research staff in an academic or hospital-based research environment
Strong working knowledge of GCP, federal regulations, IRB requirements, and institutional research policies
Preferred
A Master's Degree is preferred
Company
Boston Children's Hospital
Boston Children's Hospital is a 404-bed comprehensive center for pediatric health care.
Funding
Current Stage
Late StageRecent News
2024-04-25
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2024-04-25
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2024-04-25
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