Children's National Medical Center
Clinical Research Assistant
Children's National Medical Center, Washington, District of Columbia, us, 20022
Job Description
Clinical Research Assistant – 250002RZ
Supports the conduct of clinical research under the direction of a senior research team member. Develops functional knowledge of Good Clinical Practice (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations.
Responsibilities
Identifies eligible participants under the supervision of a senior research team member.
Prepares necessary documents, equipment and supplies for research visits.
Conducts and documents visits and protocol‑specific testing/interviews according to study protocol, operational plans and SOPs.
Maintains accurate IRB submissions and records participant visits in the appropriate tracking system.
Plans, conducts and manages research activities in accordance with federal regulations and sponsor and institutional policies.
Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC).
Responds to queries within sponsor and institutional timelines and maintains secure storage of study documents.
Demonstrates collaborative and respectful behavior and partners with all team members to achieve goals.
Qualifications
Minimum Education : BA/BS degree in a science, technical, health‑related field or another applicable discipline (Required).
Minimum Work Experience : 0 years experience working in a medical or scientific research setting (Preferred).
Functional Accountabilities – Responsible Conduct of Research :
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 regarding human subjects research and use of protected health information.
Uses research funds and resources appropriately and maintains confidentiality of data as required.
Meets all annual job‑related training and compliance requirements.
Research Administration :
Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility.
Accurately creates, completes, maintains and organizes study documents and accounts for study materials.
Uses and accounts for research funds and resources at performance level and reconciles research subject billing if assigned.
Attends study meetings and works well with other members of the research team.
Adheres to the IRB‑approved recruitment plan and engages participants/LARs in the informed consent process.
Study Management :
Plans, conducts and manages research activities in accordance with federal regulations, sponsor and institutional policies under the direction of a senior study team member.
Conducts and documents visits and protocol‑specific testing/interviews according to study protocol and SOPs.
Completes accurate IRB submissions within institutional timeframes and records participant visits in the appropriate tracking system.
Data Collection :
Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC).
Plans and performs research specimen collection, labeling and storage/shipping, maintaining accurate sample accountability.
Ensures secure storage of study documents and assists in maintaining regulatory documents per sponsor and institutional requirements.
Employment Details Primary Location: District of Columbia – Washington Work Location: CN Hospital (Main Campus) 111 Michigan Avenue NW Washington 20010 Position Status: R (Regular) – FT – Full‑Time Shift: Day Work Schedule: 8:30 a‑5 p
EEO Statement Children’s National Hospital is an equal‑opportunity employer that evaluates qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or other characteristics protected by law.
Drug‑Free Workplace Policy Children’s National Hospital maintains a drug‑free workplace and prohibits the illegal use, possession or distribution of controlled substances.
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Responsibilities
Identifies eligible participants under the supervision of a senior research team member.
Prepares necessary documents, equipment and supplies for research visits.
Conducts and documents visits and protocol‑specific testing/interviews according to study protocol, operational plans and SOPs.
Maintains accurate IRB submissions and records participant visits in the appropriate tracking system.
Plans, conducts and manages research activities in accordance with federal regulations and sponsor and institutional policies.
Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC).
Responds to queries within sponsor and institutional timelines and maintains secure storage of study documents.
Demonstrates collaborative and respectful behavior and partners with all team members to achieve goals.
Qualifications
Minimum Education : BA/BS degree in a science, technical, health‑related field or another applicable discipline (Required).
Minimum Work Experience : 0 years experience working in a medical or scientific research setting (Preferred).
Functional Accountabilities – Responsible Conduct of Research :
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 regarding human subjects research and use of protected health information.
Uses research funds and resources appropriately and maintains confidentiality of data as required.
Meets all annual job‑related training and compliance requirements.
Research Administration :
Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility.
Accurately creates, completes, maintains and organizes study documents and accounts for study materials.
Uses and accounts for research funds and resources at performance level and reconciles research subject billing if assigned.
Attends study meetings and works well with other members of the research team.
Adheres to the IRB‑approved recruitment plan and engages participants/LARs in the informed consent process.
Study Management :
Plans, conducts and manages research activities in accordance with federal regulations, sponsor and institutional policies under the direction of a senior study team member.
Conducts and documents visits and protocol‑specific testing/interviews according to study protocol and SOPs.
Completes accurate IRB submissions within institutional timeframes and records participant visits in the appropriate tracking system.
Data Collection :
Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC).
Plans and performs research specimen collection, labeling and storage/shipping, maintaining accurate sample accountability.
Ensures secure storage of study documents and assists in maintaining regulatory documents per sponsor and institutional requirements.
Employment Details Primary Location: District of Columbia – Washington Work Location: CN Hospital (Main Campus) 111 Michigan Avenue NW Washington 20010 Position Status: R (Regular) – FT – Full‑Time Shift: Day Work Schedule: 8:30 a‑5 p
EEO Statement Children’s National Hospital is an equal‑opportunity employer that evaluates qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or other characteristics protected by law.
Drug‑Free Workplace Policy Children’s National Hospital maintains a drug‑free workplace and prohibits the illegal use, possession or distribution of controlled substances.
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