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. Develops progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations, when applicable. Identifies participants that meet eligibility requirements, under the supervision of a senior research team member. Prepares necessary documents, equipment, supplies, etc. for research visits. Conducts and documents 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 under direction. Maintains subject level documentation for minimal risk studies, or for other studies under direction. Follows procedures for documenting participant incentive distribution. Assists in maintaining regulatory documents per sponsor and institutional requirements. Plans and coordinates research specimen collections and shipping.
Specific Requirements and Preferences
Bachelor's or equivalent combination of experience and education. BA/BS degree in a science, technical, health-related field or another applicable
Specific Requirements and Preferences
Experience working in a medical or scientific research setting (Preferred)
Responsible Conduct of Research
1. Demonstrates consistent adherence to the standards for responsible conduct of research.
2. 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.
3. Maintains knowledge and comprehension of assigned research protocols; including study procedures, timelines and eligibility.
4. Creates, accurately completes, maintains and organizes study documents. Accounts for study materials. This may include, but is not limited to participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s), and participation incentives.
5. Cooperates with sponsor, institutional and federal monitoring/ auditing activities. May collaborate with study team in formulating responses to findings.
6. Uses and accounts for research funds and resources at his/her performance level. This includes reconciling research subject billing, if assigned.
7. Complies with and maintains current documentation of all job-related training and conflict of interest reporting.
8. Reports good faith suspicions of research noncompliance and/or research misconduct to the appropriate institutional compliance office(s).
1. Adheres to the IRB approved recruitment and enrollment plan.
2. Screens subjects for eligibility per the protocol and institutional policies.
3. Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies.
4. Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose, participation details and to assess participation interest.
5. Engages participants/LARs in the informed consent process according to institutional policies.
1. 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 .
2. Completes accurate IRB submissions within institutional timeframes.
3. Records participant visits in the appropriate tracking system.
4. Anticipates study needs and subject caseload to meet organizational objectives and deadlines in a timely manner.
5. Works well with other members of the research team. This includes appreciating multiple workplace diversities and seeking and providing input, when appropriate.
6. Attends study meetings (which could include overnight travel) as requested by the PI
1. Assures that data is collected as required by the protocol and in accordance with research data principles (ALCOAC: Attributable, Legible, Contemporaneous, Original, Accurate and Complete).
2. Ensures that queries are resolved within sponsor and institutional timelines.
3. Plans and performs (if assigned) research specimen collection, labeling, and storage/shipping. Maintains accurate sample accountability/chain of custody documentation.
4. Ensures secure storage of study documents.
Organizational Accountabilities (Staff)
Organizational Commitment/Identification 1. Anticipate and responds to customer needs; follows up until needs are met
Teamwork/Communication 1. Demonstrate collaborative and respectful behavior
2. Partner with all team members to achieve goals
3. Receptive to others' ideas and opinions
Performance Improvement/Problem-solving 1. Contribute to a positive work environment
2. Demonstrate flexibility and willingness to change
3. Identify opportunities to improve clinical and administrative processes
4. Make appropriate decisions, using sound judgment
Cost Management/Financial Responsibility 1. Use resources efficiently
2. Search for less costly ways of doing things
Safety 1. Speak up when team members appear to exhibit unsafe behavior or performance
2. Continuously validate and verify information needed for decision making or documentation
3. Stop in the face of uncertainty and takes time to resolve the situation
4. Demonstrate accurate, clear and timely verbal and written communication
5. Actively promote safety for patients, families, visitors and co-workers
6. Attend carefully to important details – practicing Stop, Think, Act and Review in order to self-check behavior and performance
Children's National Health System 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.