Clinical Research Assistant

About the Role

Children's National Hospital is seeking a dedicated Clinical Research Assistant to support clinical research activities. This role involves performing various research, data, and clerical tasks under the guidance of senior research staff. The successful candidate will gain a comprehensive understanding of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations, and Food and Drug Administration (FDA) regulations. Key responsibilities include identifying potential participants, preparing for research visits, and conducting protocol-specific testing and interviews.

Functional Accountabilities

Responsible Conduct of Research

• Adhere consistently to standards for the responsible conduct of research.
• Manage research projects in compliance with federal and institutional regulations and policies, under the principal investigator's direction.
• Stay updated on and comply with institutional policies and federal regulations (e.g., Titles 21 and 45 of the Code of Federal Regulations) and guidance (International Council on Harmonization) concerning human subjects research and protected health information.
• Utilize research funds and resources appropriately.
• Maintain data confidentiality as required.
• Complete all annual job-related training and compliance requirements.

Research Administration

• Maintain thorough knowledge of assigned research protocols, including study procedures, timelines, and eligibility criteria.
• Accurately create, maintain, and organize study documentation.
• Manage and account for study materials such as participant lists, visit logs, regulatory binders, case report forms, laboratory kits, investigational products, and participant incentives.
• Manage research funds and resources effectively, including reconciling research subject billing if assigned.
• Attend study meetings, potentially including overnight travel, as directed by the principal investigator.
• Collaborate effectively with the research team, seeking and providing input as needed.

Participant Enrollment

• Follow the Institutional Review Board (IRB)-approved recruitment plan.
• Identify participants who meet eligibility requirements, with supervision from a senior research team member.
• Screen subjects for eligibility according to the protocol and institutional policies.
• Communicate effectively with a diverse and potentially vulnerable subject population, adhering to institutional policies.
• Engage study participants and/or their legally authorized representatives (LARs) to explain the study's purpose, participation details, and assess interest.
• Facilitate the informed consent process in accordance with institutional policies.
• Follow procedures for documenting the distribution of participant incentives.

Study Management

• Plan, conduct, and manage research activities in alignment with federal regulations, guidance documents, and sponsor and institutional policies, under the direction of a senior study team member.
• Perform and document visits and protocol-specific testing/interviews according to study protocols, clinical department operational plans, and Standard Operating Procedures (SOPs) for minimal risk studies or other studies as directed.
• Complete accurate IRB submissions within institutional deadlines.
• Record participant visits in the designated tracking system.
• Proactively anticipate study needs and subject caseload to meet organizational objectives and deadlines efficiently.

Data Collection

• Ensure data is collected as per protocol requirements and adheres to research data principles (ALCOAC: Attributable, Legible, Contemporaneous, Original, Accurate, and Complete).
• Ensure query resolution within sponsor and institutional timelines.
• If assigned, plan and execute research specimen collection, labeling, and storage/shipping, maintaining accurate sample accountability and chain of custody documentation.
• Ensure secure storage of study documents and assist in maintaining regulatory documents per sponsor and institutional requirements.
• Anticipate and respond to customer needs, ensuring follow-up until needs are met.

Teamwork/Communication

• Exhibit collaborative and respectful behavior.
• Work in partnership with all team members to achieve objectives.
• Be receptive to the ideas and opinions of others.

Performance Improvement/Problem-solving

• Contribute to a positive work environment.
• Demonstrate flexibility and adaptability to change.
• Identify opportunities to enhance clinical and administrative processes.
• Make sound decisions using good judgment.

Cost Management/Financial Responsibility

• Utilize resources efficiently.
• Seek cost-effective solutions.

Safety

• Speak up if team members display unsafe behavior or performance.
• Continuously validate and verify information for decision-making or documentation.
• Pause in situations of uncertainty to resolve the issue.
• Communicate clearly, accurately, and promptly, both verbally and in writing.
• Actively promote safety for patients, families, visitors, and colleagues.
• Pay close attention to detail, employing a Stop, Think, Act, and Review approach to self-check behavior and performance.

Additional Information

This position is based at the CN Hospital (Main Campus) in Washington, DC. The work schedule is Monday - Friday, 8:00 am - 4:30 pm. This is a regular, full-time position within the COE Hospital-Based Specialties department.