Operations:

• Screen, consent, schedule and conduct visits, and maintain subject level documentation for participants in all studies independently.
• Collect, prepare, process, ship, and maintain inventory of research specimens.
• Assist with management of IP.
• Coordinate with investigational pharmacy. Independently maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc.
• Provide direction to study teams with preparation for study monitoring or study audit visits. Address and correct audit/monitor findings.
• Collect, prepare or process adverse event information independently.
• Complete and submit AE Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms) independently.
• Develop DUHS IRB documents such as consent forms, protocols, and continuing reviews independently. 

Ethics:
Make recommendations regarding how to improve communications to help patients and staff understand the distinction between clinical care and research. Be familiar with the ethical conduct of research, and safeguards needed when conducting research with vulnerable populations. Understand that the safety of research participants is a priority. Identify and the explain the risk and benefits to a subject as these pertain to your clinical trial

Data:
Map a protocol's data flow plan: data capture, storage, management, quality, and preparation for analysis Use Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations with little assistance. Enter data accurately. Score tests and measures according to protocol, and appropriate to role. Complete paper and electronic Case Report Forms (CRFs and eCRFs) accurately and according to protocol. Independently investigate issues related to accuracy and completeness of data. Develop and run queries and reports. Recognize trends related to data quality and escalate as appropriate. Follow SOPs for data QA.

Leadership:
Encourage and support colleagues in completing project work. Assist research colleagues in identifying efficiencies and improving process. Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research. Maintain Duke and project specific training requirements.

Study and Site Management: 
Collect information to determine appropriate feasibility, recruitment and retention strategies. Ensure participant care expenses have appropriate financial routing in a timely manner. Monitor financial study milestones and report appropriately. Maintain study's compliance with institutional requirements and other policies (e.g., NIH Public Access policy, ct.gov, Research Data Security Plans, Social Media policy, etc.). Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties. Take part in site initiation and closeout meetings independently Develop protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms. Take part in or lead closeout and document storage activities

Communication:

• Serve as primary liaison with single sponsor, subcontractor, or vendors, communicating concerns clearly and in a professional manner.
• Respond to routine questions related to study protocol and refer more complex questions to others as appropriate. 

Description of Portfolio and Clinical Responsibilities:
Clinical responsibilities:

• Ambulatory Medication Administration
• Adult Medication
• Peripheral IV Insertion and Maintenance
• Alaris Pump Set up and Use

Type of Research 
This position will be involved with several clinically active trials taking place in both the main hospital and the outpatient setting. Due to the nature of the trials there will be an expectation of participating in a shared on-call system and flexibility with work hours is needed.