Children's National Medical Center
Clinical Research Assistant
Children's National Medical Center, Washington, District of Columbia, us, 20022
Job Title:
Clinical Research Assistant (240002B2)Description:The Clinical Research Assistant 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 Research Assistant will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations, and Food and Drug Administration (FDA) regulations. In this role, the Clinical Research Assistant completes tasks including identifying eligible participants under the supervision of a senior research team member, preparing necessary documents, equipment, supplies, etc. for research visits, and conducting and documenting visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments, and Standard Operating Procedures (SOPs) for minimal risk studies or for other studies.Qualifications:Minimum Education:Bachelor's Degree 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.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 the 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:Demonstrates collaborative and respectful behavior.Partners with all team members to achieve goals.Receptive to others’ ideas and opinions.Performance Improvement/Problem-solving:Contributes to a positive work environment.Demonstrates flexibility and willingness to change.Identifies opportunities to improve clinical and administrative processes.Makes appropriate decisions, using sound judgment.Uses resources efficiently.Searches for less costly ways of doing things.Safety:Speaks up when team members appear to exhibit unsafe behavior or performance.Continuously validates and verifies information needed for decision making or documentation.Stops in the face of uncertainty and takes time to resolve the situation.Demonstrates accurate, clear, and timely verbal and written communication.Actively promotes safety for patients, families, visitors, and co-workers.Attends carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance.Primary Location:
District of Columbia-WashingtonWork Locations:
CN Hospital (Main Campus), 111 Michigan Avenue NW, Washington 20010Job:
ResearchOrganization:
Ctr Clinical & Community RsrchPosition Status:
R (Regular) - FT - Full-TimeShift:
DayWork Schedule:
Monday - FridayJob Posting:
Aug 22, 2024, 6:32:12 PMFull-Time Salary Range:
42702.4 - 71156.8Childrens 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.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 (as defined in the Controlled Substances Act), or the misuse of legal substances, by all staff (management, employees, and contractors).
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Clinical Research Assistant (240002B2)Description:The Clinical Research Assistant 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 Research Assistant will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations, and Food and Drug Administration (FDA) regulations. In this role, the Clinical Research Assistant completes tasks including identifying eligible participants under the supervision of a senior research team member, preparing necessary documents, equipment, supplies, etc. for research visits, and conducting and documenting visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments, and Standard Operating Procedures (SOPs) for minimal risk studies or for other studies.Qualifications:Minimum Education:Bachelor's Degree 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.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 the 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:Demonstrates collaborative and respectful behavior.Partners with all team members to achieve goals.Receptive to others’ ideas and opinions.Performance Improvement/Problem-solving:Contributes to a positive work environment.Demonstrates flexibility and willingness to change.Identifies opportunities to improve clinical and administrative processes.Makes appropriate decisions, using sound judgment.Uses resources efficiently.Searches for less costly ways of doing things.Safety:Speaks up when team members appear to exhibit unsafe behavior or performance.Continuously validates and verifies information needed for decision making or documentation.Stops in the face of uncertainty and takes time to resolve the situation.Demonstrates accurate, clear, and timely verbal and written communication.Actively promotes safety for patients, families, visitors, and co-workers.Attends carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance.Primary Location:
District of Columbia-WashingtonWork Locations:
CN Hospital (Main Campus), 111 Michigan Avenue NW, Washington 20010Job:
ResearchOrganization:
Ctr Clinical & Community RsrchPosition Status:
R (Regular) - FT - Full-TimeShift:
DayWork Schedule:
Monday - FridayJob Posting:
Aug 22, 2024, 6:32:12 PMFull-Time Salary Range:
42702.4 - 71156.8Childrens 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.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 (as defined in the Controlled Substances Act), or the misuse of legal substances, by all staff (management, employees, and contractors).
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