Clinical Research Project Manager jobs in United States
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Children's National Hospital · 2 days ago

Clinical Research Project Manager

Children's National Hospital is seeking a Clinical Research Project Manager to oversee project activities for the International Rare Brain Tumor Registry program. The role involves managing research projects, maintaining regulatory documents, ensuring compliance with study protocols, and collaborating with partner sites.

AssociationChild CareHealth CareNon Profit
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H1B Sponsor Likelynote

Responsibilities

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

Qualification

Clinical Research ExperienceRegulatory Document ManagementProject ManagementBudget ManagementClinical Research CertificationTeam CollaborationProblem-solvingCommunication Skills

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
Desired Certification as a Clinical Research Professional (CCRP) or equivalent, or be in process of being certified
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

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Children’s National Hospital, based in Washington, D.C., was established in 1870 to help every child grow up stronger.

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 Stage
Total Funding
$19.4M
Key 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

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Kurt Newman
President and CEO
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Michelle Riley-Brown, MHA, FACHE
President and CEO
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Company data provided by crunchbase