Clinical Research Assistant

Children's National Hospital

About the Role

Supports the conduct of clinical research under the direction of a senior research team member. Develops functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations, and Food and Drug Administration (FDA) regulations.

Key Responsibilities

• Identifies eligible participants under supervision.
• Prepares necessary documents, equipment, and supplies for research visits.
• Conducts and documents visits and protocol-specific testing/interviews.
• Adheres to standards for the responsible conduct of research.
• Plans, conducts, and manages research projects within federal and institutional regulations.
• Stays informed of and adheres to institutional policies and federal regulations.
• Uses research funds and resources appropriately.
• Maintains confidentiality of data.
• Meets all annual job-related training and compliance requirements.
• Maintains knowledge and comprehension of assigned research protocols.
• Accurately creates, completes, maintains, and organizes study documents.
• Accounts for study materials.
• Uses and accounts for research funds and resources.
• Reconciles research subject billing if assigned.
• Attends study meetings, which could include overnight travel.
• Works collaboratively with the research team.
• Adheres to the IRB-approved recruitment plan.
• Screens subjects for eligibility per protocol and institutional policies.
• Communicates effectively with diverse, vulnerable subject populations.
• Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details.
• Assesses participation interest.
• Engages participants/LARs in the informed consent process.
• Follows procedures for documenting participant incentive distribution.
• Plans, conducts, and manages research activities in accordance with regulations and policies.
• Records participant visits in the appropriate tracking system.
• Anticipates study needs and subject caseload.
• 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.
• Assists in maintaining regulatory documents.

Requirements & Tech Stack

• Bachelor's Degree in a science, technical, health-related field, or another applicable discipline.

Qualifications

• 0 years experience working in a medical or scientific research setting (Preferred).
• Progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations, and Food and Drug Administration (FDA) regulations.
• Knowledge of Titles 21 and 45 of the Code of Federal Regulations and guidance (International Counsel on Harmonization) regarding human subjects research and use of protected health information.
• Understanding of ALCOAC data principles.

Pay Range

$20.83 - $34.71