Children's National Hospital · 1 month ago
Clinical Research Project Manager
CN Hospital (Main Campus)111 Michigan Avenue NW
Full-time
Onsite
Entry, Mid Level
1+ years expChildren's National Hospital is seeking a Clinical Research Project Manager to coordinate project activities for the International Rare Brain Tumor Registry program. The role involves managing research projects, ensuring compliance with clinical trial regulations, and collaborating with various stakeholders to support the research initiatives.
AssociationChild CareHealth CareNon Profit
Responsibilities
Responsible for the overall coordination of project activities and perform a variety of research duties in support of the International Rare Brain Tumor Registry (IRBTR) program
Manage assigned research projects and work collaboratively with the Brain Tumor Institute team and international partner sites and will report to the IRBTR Principal Investigator (PI)
Create, submit and maintain ongoing legal and regulatory documents for clinical trials, to include the preparation site agreements and IRB applications
Work with the assigned partner sites to track subsite patient enrollments, manage transfer of patient data and materials, and ensure compliance with study protocol and the different grant funding agency and government clinical research policies
Manage program budget, including executing orders and payments, creating spending projections, and periodic financial reporting
Support the PI in ensuring that program activities align with funder/grant funding agency intent and policies and BTI clinical research priorities
Monitor readiness of sites and their ongoing performance to enroll patients and submit data submission
Support multiple projects and is expected to take initiative, be able to work independently and problem-solve
Plan, conduct, and manage research projects within the federal and institutional regulations and policies under the direction of the principal investigator
Maintain regulatory documents as per standard operating procedures as well as specific to the multi-center trial as set by the funding agencies and government regulations for the assigned projects (e.g. NIH, PCORI, FDA, etc.)
Ensure regulatory integrity of protocols through preparation and submission of the protocol, consent forms, protocol amendments, and annual progress/continuing reviews to the IRB, and as appropriate, to the FDA, for approval
Assist and review other research sites with their ethics submissions
Assist in writing multicenter protocols and consent
Assist in the development of the assigned project manuals of operations
Work with the assigned sites to prepare all study start-up activities and confirm assigned sites have the necessary approvals
Track data expectancy for the assigned sites
Perform remote and on-site reviews of study documents for assigned
Ensure all necessary data are gathered and recorded in the appropriate source documents, case report forms, and electronic data capture systems, review case report form entries for completeness, correctness and logical sense, during site monitoring visits
Maintain regular communication with assigned study chair and sites
Collaborate with other departments (laboratory, research pharmacy, etc.), as necessary
Monitor expenditures for the assigned projects, work closely with the assigned financial personnel and data managers, who confirm data completion as part of approval of payments
Identify issues and challenges and work with the study’s Coordinating Center Director to resolve any matters
Assist the PI of the multi-center study with the execution of the study investigator meetings; responsible for all logistics of the meeting
Review journals, abstracts and scientific literature to keep abreast of new development and to obtain information relevant to clinical research programs
Attend and contribute to team meetings, including working to set and achieve project timelines and deliverables
Attend training or workshops of clinical research professionals as needed for growth
Qualification
Required
Bachelor's Degree BA/BS degree in science, technical, or health-related field with 3-5 year relevant experience or MS degree with 1-3 years relevant experience
At least 1-4 years of multi-center clinical research experience. Or an equivalent combination of relevant education and/or experience
Desired Certification as a Clinical Research Professional (CCRP) or equivalent, or be in process of being certified. The current certifying bodies for clinical research professionals include Society of Clinical Research Associates (SoCRA) and the Association of Clinical Research Professionals (ACRP)
Consistently demonstrate adherence with the standards for the responsible conduct of research
Plan, conduct, and manage research projects within the federal and institutional regulations and policies under the direction of the principal investigator
Responsible for appropriate use of research funds and resources
Comply with all annual job-related training requirements
Maintain regulatory documents as per standard operating procedures as well as specific to the multi-center trial as set by the funding agencies and government regulations for the assigned projects (e.g. NIH, PCORI, FDA, etc.)
Ensure regulatory integrity of protocols through preparation and submission of the protocol, consent forms, protocol amendments, and annual progress/continuing reviews to the IRB, and as appropriate, to the FDA, for approval
Assist and review other research sites with their ethics submissions
Assist in writing multicenter protocols and consent
Assist in the development of the assigned project manuals of operations
Work with the assigned sites to prepare all study start-up activities and confirm assigned sites have the necessary approvals
Track data expectancy for the assigned sites
Perform remote and on-site reviews of study documents for assigned
Ensure all necessary data are gathered and recorded in the appropriate source documents, case report forms, and electronic data capture systems, review case report form entries for completeness, correctness and logical sense, during site monitoring visits
Maintain regular communication with assigned study chair and sites
Collaborate with other departments (laboratory, research pharmacy, etc.), as necessary
Monitor expenditures for the assigned projects, work closely with the assigned financial personnel and data managers, who confirm data completion as part of approval of payments
Identify issues and challenges and work with the study's Coordinating Center Director to resolve any matters
Assist the PI of the multi-center study with the execution of the study investigator meetings; responsible for all logistics of the meeting
Review journals, abstracts and scientific literature to keep abreast of new development and to obtain information relevant to clinical research programs
Attend and contribute to team meetings, including working to set and achieve project timelines and deliverables
Attend training or workshops of clinical research professionals as needed for growth
Anticipate and responds to customer needs; follows up until needs are met
Demonstrate collaborative and respectful behavior
Partner with all team members to achieve goals
Receptive to others' ideas and opinions
Contribute to a positive work environment
Demonstrate flexibility and willingness to change
Identify opportunities to improve clinical and administrative processes
Make appropriate decisions, using sound judgment
Use resources efficiently
Search for less costly ways of doing things
Speak up when team members appear to exhibit unsafe behavior or performance
Continuously validate and verify information needed for decision making or documentation
Stop in the face of uncertainty and takes time to resolve the situation
Demonstrate accurate, clear and timely verbal and written communication
Actively promote safety for patients, families, visitors and co-workers
Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance
Company
Children's National Hospital
Children’s National Hospital, based in Washington, D.C., was established in 1870 to help every child grow up stronger.
Founded in 1870Washington, District of Columbia, USA
5001-10000 employees
H1B Sponsorship
Children's National Hospital has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (82)
2024 (55)
2023 (92)
2022 (59)
2021 (41)
2020 (51)
Funding
Current Stage
Late StageTotal Funding
$19.4MKey Investors
Gilbert Family FoundationAdvanced Research Projects Agency for HealthUnited Health Foundation
2025-10-09Grant· $8M
2024-10-23Grant· $8M
2021-11-09Grant· $3.4M
Leadership Team
Kurt Newman
President and CEO
Michelle Riley-Brown, MHA, FACHE
President and CEO
Recent News
BioWorld Financial Watch
2025-06-07
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