CLINICAL RESEARCH COORDINATOR - Orthopedics
School of Medicine:
Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.
Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
**Travel between sites in Wake and Durham counties is an essential part of this position. Working with physicians in both Raleigh and Durham, and in multiple clinics, the CRC in this role will rarely be in one location an entire day.
Hoteling office space will be provided onsite.
Screen participants for all studies independently. Maintain subject level documentation for all studies independently 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. 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. Conduct and document consent for participants in a variety of studies independently Assist with addressing and correcting findings from study monitoring and study audit visits. 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. 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.
Recognize when patients are having difficulties understanding the distinction between clinical care and research activities. Make recommendations regarding how to improve communications to help patients and staff understand the distinction. 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. Assist with the development of Conflict of Interest (COI)/Data Safety Monitoring Plans (DSMPs)/Research Data Security Plans (RDSPs). Assist with the coordination of 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.
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. Use required processes, policies, and systems to ensure data security and provenance. Independently investigate incomplete, inaccurate or missing data/documents
to ensure accuracy and completeness of data. Run summaries and reports on existing data 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. 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. 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 Recognize components of operational plans and be able to obtain information needed to develop the plan. 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
Serve as primary liaison with sponsor(s), subcontractor(s), or vendor(s). 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.
This position will be primarily working with two sports medicine surgeons in Raleigh/Wake Cty on mostly sponsored investigational device trials for knees and shoulders. These trials will necessitate some time in the OR, urine collection and making blood draws. The CRC will also handle investigational products.
The CRC in this position will be held to a high standard regarding the regulatory and patient facing parts of the study. While there is oversight for this position, the CRC in this role will work independently more often than not. Periodic audits of the work will focus on the standards being met at all times.
Work structure and environment
Travel between sites in Wake and Durham counties is an essential part of this position. Working with physicians in both Raleigh and Durham, and in multiple clinics, the CRC in this role will rarely be in one location an entire day. Hoteling office space will be provided onsite.
As stated earlier, this position will need to work independently and with occasional physical oversight. However, the remote teamwork skills cannot be emphasized enough. The team meets weekly by phone or teleconference for the purpose of cross-coverage and training as well as knowledge sharing. The CRC in this role must know how to maximize the available support and must contribute to the team’s effort by expertly utilizing remote work tools and demonstrating positive teamwork at all times.Minimum Qualifications
Completion of an Associate's degree
Work requires a minimum of two years of relevant research experience. A Bachelor's degree may substitute for 2 years required experience.
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Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.