- Requisition Number: 401468175
- 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. Independently maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc. 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. 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.
- 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. Develop documents related to safety and security (e.g., RDSPs, COIs, DSMPs). Coordinate efforts of external monitoring boards.
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 incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data. Run summaries and reports on existing data Assist with development of and follow SOPs for data quality assurance. Assemble the necessary parties to ensure that all agreements are in place (DUA, DTA, etc.)
- Leadership: Actively network and encourage leadership for staff within a small work group. Take part in a committee, task force, or ad hoc group. Encourage career development by actively seeking out continuing education opportunities for self and study team members.
Participate in scientific presentations and publications. May serve as mentor to other staff. Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct of clinical research. Maintain training requirements and develop solutions to proactively ensure study team members' compliance with training requirements.
Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research. Make recommendations to investigative team.
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. 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.
- Serve as primary liaison with single sponsor, subcontractor, or vendors. Communicate concerns clearly and in a professional manner. 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.
Type of Research - Type of research will be both retrospective and prospective in nature. Complexity may vary from non complex to complex autoimmune disease protocols.. The position would involve a lot of regulatory work (study start up, maintaining of study documentation, OnCore and Maestro documentation) and possibility of internal auditing of projects.
At the same time, there will also be involvement in subject visits, consenting to all types of studies. projects. Special Skills - Knowledge of medical terminology. Some previous experience in clinical research. Organizational skills. Demonstrated attention to detail, supervision of Research Project Manager; assist with completing IRB submissions and renewals for studies as needed and assist with preparing regulatory documents such as creating binders, subject logs, etc.; may consent on databases or registries if needed.
Follow contracts in process: track status with sponsor as well as in the Duke system to ensure contracts continue moving through the proper process Create and maintain grids to indicate funding source of each clinical trial event.
Build study tracker for assigned studies and monitor to ensure study team is using the system appropriately and entering events as required Enter and update budget information in the Sponsored Projects System Assist with central invoicing for clinical trials and track payments received.
Complete Internal Cost Summary for approval of sponsored contracts and assist PIs with completing Internal Cost Summaries for internally funded projects.
Reconcile budgets with sponsor to ensure invoices have been paid and that quarterly statements are correct; review payment records at the end of each study to ensure all payments are accounted for and reconcile internal records with sponsor records