Children's National Hospital · 3 days ago
HIV - Sr. Clinical Research Coordinator
Children's National Hospital is a leading healthcare organization focused on clinical research. The Senior Clinical Research Coordinator will independently lead day-to-day operations of clinical research studies, manage participant recruitment, and ensure compliance with regulations while coordinating with multiple stakeholders.
AssociationChild CareHealth CareNon Profit
Responsibilities
Consistently demonstrates adherence to the standards for the responsible conduct of research
Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator
Stays informed of and adheres to institutional policies, and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and guidances (International Counsel on Harmonization) regarding human subjects’ research and use of protected health information
Uses research funds and resources appropriately
Maintains confidentiality of data as required
Meets all annual job-related training and compliance requirements
Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility
Accurately creates, completes, maintains, organizes and accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives
Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned
Attends study meetings, which could include overnight travel, as requested by principal investigator
Works well with other members of the research team, appreciates a diverse workplace and seeks and provides input when appropriate
Serves as an effective liaison between the investigators, sponsors, hospital departments involved with research studies and the Clinical Research Center
Identifies and resolves issues and challenges with appropriate input and oversight
Reviews journals, abstracts and scientific literature to obtain information relevant to clinical research programs
Creates standard operating procedures (SOPs), and implements operational plans
Provides oversight and training to study team members for a variety of studies
Develops study documents, including consent forms and protocols
Adheres to the IRB-approved recruitment plan
Screens subjects for eligibility per the protocol and institutional policies
Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies
Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest
Engages participants/LARs in the informed consent process according to institutional policies
Conducts/participates in feasibility assessments to ensure adequate site resources and infrastructure are available for protocol participation
Plans, conducts and manages research activities in accordance with federal regulations and guidance documents and sponsor and institutional policies under the direction of a senior study team member
Ensures regulatory integrity of protocols through the accurate and timely preparation and submission of documents and reports to the sponsor, IRB and other oversight bodies in accordance with federal regulations, sponsor SOPs and institutional policies
Authors study submissions and related documents based on functional role; this may include IRB contingency responses, ClinicalTrials.gov postings, Certificate of Confidentiality applications and scholarly presentations and publications
Registers and records participant visits in the appropriate tracking system
Anticipates study needs and subject caseload to meet organizational objectives and deadlines in a timely manner
Coordinates, prepares for and responds to routine oversight body visits and audits
Independently authors reports to oversight bodies and/or trains and oversees staff performing these tasks
Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC: Attributable, Legible, Contemporaneous, Original, Accurate and Complete)
Ensures that queries are resolved within sponsor and institutional timelines
Plans and performs research specimen collection, labeling and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation
Ensures secure storage of study documents
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
Required
B.A./B.S. degree in a science, technical, health-related field or other applicable discipline with at least 3 years of relevant experience
Master's Degree with at least 2 years of relevant experience
At least 3 years of experience with a bachelor's degree
At least 2 years of experience with a master's degree
Knowledge of clinical research designs and needed infrastructure
Familiarity with databases, data collection tools and data analysis methods
Ability to manage multiple complex activities while maintaining close attention to detail and not losing sight of the organizational mission
Interpersonal skills that demonstrate formal and informal leadership in a diverse professional environment
Internal candidates: Certification as a Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA) or equivalent research certification. Upon Hire
External candidates: Certification as a Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA) or equivalent research certification within one year of hire
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.
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
Recent News
BioWorld Financial Watch
2025-06-07
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