CLINICAL RESEARCH COORDINATOR
- Location: Durham, NC
- Posted: Oct 8, 2019
School of Medicine:
Established in 1930, Duke University School of Medicine is the youngest of the nations 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.
Participate in or lead day-to-day operations of clinical research studies conducted by principal investigator(s) at Duke Medicine; perform a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data. May oversee the work of junior staff.
1.Clinical research operations. Screen, schedule, consent, and collect adverse events (AE) information for participants in a variety of studies. Maintain subject level documentation, including documentation of consent in the electronic medical record. Prepare documents, equipment, or supplies for research visits. Conduct and document visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments, and Standard Operating Procedures (SOPs) for all types of studies independently. 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. May provide training to personnel. Collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks; improve systems related to specimen handling. Prepare for study monitoring or study audit visits. Assist with addressing and correcting findings. Develop or provide input for IRB documents. Maintain, or collaborate to maintain, appropriate study-level documentation. Assist with management of Investigational Products (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. Collect, prepare, or process adverse event information per protocol, and provide input for adverse event reports. May complete and submit AE Reports, according to institution and sponsor-specific reporting requirements. 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. Recognize the need for agreements (e.g., Material Transfer Agreements, Investigational New Drug Applications, etc.).
2.Ethical and participant safety considerations. Maintain familiarity with the ethical conduct of research and safeguards needed when conducting research. Train junior staff in the ethical conduct of research. May help in the design of studies so they include specific safeguards to ensure ethical conduct and protect vulnerable populations. May develop, or assist with the development of, documents related to safety and security. Communicate to research participants the difference between clinical activities and research activities, and the risks and benefits of study participation.
3.Data management and informatics. Use and train others in Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations. Score tests, enter data, and complete Case Report Forms accurately and according to protocol. Assist with the development of, or develop, data collection documents and instruments. Detect issues related to data capture, collection or management; suggest solutions. Investigate incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data; follow and develop, or assist with development of, SOPs for data quality assurance. Adhere to processes and run queries, summaries, and reports to monitor the quality of data. May develop QA processes and oversee the creation and use of queries, summaries, and reports for quality assurance purposes. May be responsible for recognizing trends related to data quality and escalating as appropriate. Use required processes, policies, and systems to ensure data security and data provenance. Recognize and report vulnerabilities related to security of physical and electronic data; suggest and implement solutions to vulnerabilities related to security of data and data provenance. Map protocol data flow. Predict areas of vulnerability for a protocol's data flow plan. Determine areas where data provenance may be compromised and develop solutions. Recognize when data agreements or special regulatory requirements are necessary; may assemble the necessary parties to ensure that all agreements are in place.
4.Scientific concepts and research design. Understand and train others in the basic concepts of study design. Independently conduct literature reviews. Assist with the development of, or develop, proposals or protocols; identify shortcomings of proposals and protocols. Identify various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of study aims. May determine operational/statistical elements needed for conduct of clinical and translational studies.
5.Leadership and professionalism. Assist research colleagues in identifying efficiencies and improving process. Successfully take part in or lead a committee or task force. Actively seek out continuing education opportunities for self and study team members. Participate in or lead scientific presentations and publications. Assign, review, and train others in various work responsibilities. Serve as a mentor to junior staff, including other CRCs. Employ escalation and performance plans as needed. Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research; summarize and clarify for study teams. May be responsible for identifying potential problems and risks to the participants, study, and institution.
6.Study and site management. Participate in sponsor-required training. Obtain information for or coordinate operational plans for multiple research studies. Develop protocol-specific systems and documents including process flows, training manuals, SOPs, and CRFs. Ensure participant care expenses have appropriate financial routing. Monitor financial study milestones and report appropriately. Coordinate with financial teams, PRMO, etc. Assist with study budgets. Prepare for, take part in, and potentially lead site initiation, monitoring, closeout visits, and document storage activities. Collect information to determine feasibility, recruitment and retention strategies. May make recommendations to investigators and oversight organization(s). Maintain compliance with institutional requirements and policies. Oversee maintenance of Delegation of Authority Logs and training of KP on study specific duties.
7.Communication and team science. Prepare for and lead team meetings. Take an active role in including others in decision-making, and escalate issues appropriately. Communicate with sponsors, subcontractors, or vendors. May be responsible for taking action when communication has stalled with sites, CROs, sponsors. Maintain Duke and project specific training requirements. 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.
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