Children's National Medical Center
Clinical Research Assistant
Children's National Medical Center, Washington, District of Columbia, us, 20022
Overview
Clinical Research Assistant - (250002RZ) performs a variety of research, data and clerical duties of a routine and technical nature to support the conduct of clinical research under the direction of a senior research team member. The role develops knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations. Tasks include identifying eligible participants under supervision, preparing necessary documents, equipment and supplies for research visits, and conducting and documenting visits and protocol-specific testing/interviews according to study protocol and SOPs for minimal risk studies or other studies.
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 (e.g. 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.
Uses research funds and resources appropriately.
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.
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 and seeks and provides input when appropriate.
Adheres to the IRB-approved recruitment plan.
Identifies participants that meet eligibility requirements under the supervision of a senior research team member.
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.
Follows procedures for documenting participant incentive distribution.
Study Management
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.
Conducts and documents visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and SOPs for minimal risk studies or for other studies under direction.
Completes accurate IRB submissions within institutional timeframes.
Records participant visits in the appropriate tracking system.
Anticipates study needs and subject caseload in order to meet organizational objectives and deadlines in a timely manner.
Data Collection
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 and assists in maintaining regulatory documents per sponsor and institutional requirements.
Anticipates and responds to customer needs; follows up until needs are met.
Teamwork/Communication
Demonstrate collaborative and respectful behavior.
Partner with all team members to achieve goals.
Receptive to others’ ideas and opinions.
Performance Improvement/Problem-solving
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.
Safety
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 take 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.
Location and Job Details
Primary Location : District of Columbia-Washington
Work Locations : CN Hospital (Main Campus) 111 Michigan Avenue NW Washington 20010
Job : Research
Organization : Ctr Clinical & Community Rsrch
Position Status: R (Regular) - FT - Full-Time
Shift: Day
Work Schedule: 8:30a-5p
Full-Time Salary Range : 42702.4 - 71156.8
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. The pay transparency policy is available here. Please note that it is the policy of Children's National Hospital to ensure a drug-free work environment: a workplace free from the illegal use, possession or distribution of controlled substances, or the misuse of legal substances. Although recreational and medical marijuana are legal in the District of Columbia, the hospital maintains the right to enforce a drug-free workplace according to policy.
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Clinical Research Assistant - (250002RZ) performs a variety of research, data and clerical duties of a routine and technical nature to support the conduct of clinical research under the direction of a senior research team member. The role develops knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations. Tasks include identifying eligible participants under supervision, preparing necessary documents, equipment and supplies for research visits, and conducting and documenting visits and protocol-specific testing/interviews according to study protocol and SOPs for minimal risk studies or other studies.
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 (e.g. 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.
Uses research funds and resources appropriately.
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.
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 and seeks and provides input when appropriate.
Adheres to the IRB-approved recruitment plan.
Identifies participants that meet eligibility requirements under the supervision of a senior research team member.
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.
Follows procedures for documenting participant incentive distribution.
Study Management
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.
Conducts and documents visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and SOPs for minimal risk studies or for other studies under direction.
Completes accurate IRB submissions within institutional timeframes.
Records participant visits in the appropriate tracking system.
Anticipates study needs and subject caseload in order to meet organizational objectives and deadlines in a timely manner.
Data Collection
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 and assists in maintaining regulatory documents per sponsor and institutional requirements.
Anticipates and responds to customer needs; follows up until needs are met.
Teamwork/Communication
Demonstrate collaborative and respectful behavior.
Partner with all team members to achieve goals.
Receptive to others’ ideas and opinions.
Performance Improvement/Problem-solving
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.
Safety
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 take 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.
Location and Job Details
Primary Location : District of Columbia-Washington
Work Locations : CN Hospital (Main Campus) 111 Michigan Avenue NW Washington 20010
Job : Research
Organization : Ctr Clinical & Community Rsrch
Position Status: R (Regular) - FT - Full-Time
Shift: Day
Work Schedule: 8:30a-5p
Full-Time Salary Range : 42702.4 - 71156.8
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. The pay transparency policy is available here. Please note that it is the policy of Children's National Hospital to ensure a drug-free work environment: a workplace free from the illegal use, possession or distribution of controlled substances, or the misuse of legal substances. Although recreational and medical marijuana are legal in the District of Columbia, the hospital maintains the right to enforce a drug-free workplace according to policy.
#J-18808-Ljbffr