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.
Required Qualifications at this Level
- Completion of a Bachelor's degree
- Completion of an Associates degree plus a minimum of two years relevant experience (e.g., research, clinical, interaction with study population, program coordination)
Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).