- Requisition Number: 401357772
- Department: MEDICAL CENTER
- Location: Durham
- Type of Position: Regular
- Shift: First/Day
Screen participants for all studies independently. May maintain subject level documentation for all studies independently. Provide oversight and training to study team members who maintain subject level documentation, including documentation in the EMR. Schedule participants and conduct visits for all studies independently. Train others to conduct and document visits and protocol-specific testing/interviews.
Assist with development and follow procedures and documentation of study payment in timely fashion. Collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks. Assist with management of IP.
Employ the required system for handling, dispensing and documentation of IP for sponsored protocols. May be responsible for determining the best methods for handling IP for Investigator-initiated protocols, or coordinating with investigational pharmacies as necessary.
Maintain appropriate documentation. Track IP compliance at the protocol-and subject level. Train staff to maintain exemplary documentation including regulatory binders, enrollment logs, patient registration in the system of record, subject level documentation, etc.
Oversee maintenance of subject level documentation. Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs.
Evaluate processes to identify issues related to recruitment and retention rates. Conduct and document consent for participants in a variety of studies independently and provide training to others in these tasks.
Provide direction to study teams with preparation for study monitoring or study audit visits. Address and correct audit/monitor findings.
Oversee the collection of adverse event information Direct study team's compliance with submission and completion of AE Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms) independently.
Have familiarity with intellectual property rights, inventions patents, and technologies. As appropriate, understand regulations related to investigational products with sponsors. Coordinate with Duke core services such as Investigational Drug Service (IDS), Biobank, etc.
Recognize the need for agreements (e.g., Material Transfer Agreements, Investigational New Drug Applications, etc.). Develop DUHS IRB documents such as consent forms, protocols, and continuing reviews independently and train other staff in these tasks.
Recognize when patients are having difficulties with this distinction. Make recommendations regarding how to improve communications to help patients and staff understand the distinction. Train junior staff in the ethical conduct of research, and provide guidance in strategies used to maintain safety. Articulate, to study staff and research participants, the pathophysiology or reasoning for an individual protocol's inclusion and exclusion criteria.
Train others on study team in use of technologies and software, and in completion of ECRFs. Assist with the development of data collection documents to standardize process. Use EDC systems and enter data accurately. Use required processes, policies, and systems to ensure data security and provenance. Recognize and report vulnerabilities related to security of physical and electronic data. 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. Assemble the necessary parties to ensure that all agreements are in place (DUA, DTA, etc.)
Encourage and support colleagues in completing project work. Assist research colleagues in identifying efficiencies and improving process. Assign, review, and train others in various work responsibilities. Serve as a mentor to junior staff, including others with my title. Employ escalation and performance plans as needed. 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:
Ensure participant care expenses have appropriate financial routing in a timely manner. Monitor financial study milestones and report appropriately. Coordinate with financial teams, PRMO, etc. and participate in budget development as appropriate. Assist with study budgets. 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 Assist with the development of 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
Write and speak clearly in a variety of settings and styles to convey messages and ideas effectively. Participate in study team meetings. Respond to routine questions related to study protocol and refer
more complex questions to others as appropriate. Communicate and coordinate with other study personnel as required for study implementation and routine problem resolution.