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.
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 event 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 Institutional Review Board documents such as consent forms, protocols, and continuing reviews in a timely fashion. Maintain or collaborate to maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc.
Assist with management of Investigational Products (IP) including arrival, storage, handling, requesting requisitions, inventory, reordering, drug accountability, reconciliation, and destruction. 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 Adverse Events Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms).
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.).
2.Ethical and participant safety considerations. Maintain familiarity 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. Train junior staff in the ethical conduct of research, dealing with vulnerable populations, and provide guidance in strategies used to maintain safety. May help in the design of studies so they include specific safeguards to ensure ethical conduct and protect vulnerable populations. May assist others will application of these principles.
May develop or assist with the development of documents related to safety and security (e.g., Research Data Security Plans, Data Safety Monitoring Plans, Conflict of Interest). Coordinate or assist with the coordination of efforts of external monitoring boards.
Communicate to research participants, both orally and written, the difference between clinical activities and research activities, and the risks and benefits of study participation, in all study documents and research participant communications. May recognize when patients are having difficulties with this
distinction. May make recommendations regarding how to improve communications to help patients and staff understand the distinction.
3.Data management and informatics. Use and train others in Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations. 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. Assist with the development of data collection documents to standardize process. Detect issues related to data capture, collection or management; suggest solutions. May independently design ECRFs and EDCs to collect data and select methods of data capture and discuss advantages and disadvantages of each.
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. May be responsible for determining solutions to vulnerabilities related to security of data and data provenance.
Recognize when data agreements or special regulatory requirements are necessary; may assemble the necessary parties to ensure that all agreements are in place (e.g., data use agreements, data transfer agreements, Investigational Device Exemptions (IDEs), etc.).
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. Encourage and support colleagues to complete project work. Assist research colleagues in identifying efficiencies and improving process. Actively network and encourage leadership for staff within a small work group. Successfully take part in or lead a committee, task force, or ad hoc group. Encourage career development by 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 Clinical Research Coordinators. Employ escalation and performance plans as needed. May be responsible for providing constructive feedback to team members.
Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research. Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct of clinical research. May be responsible for identifying potential problems and risks to the participant, study, investigator, team, sponsor, and institution.
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, standard operating procedures, and case report forms.
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. Assist with study budgets.
Prepare for, take part in, and potentially lead site initiation, monitoring, and 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 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.
6.Communication and team science. Prepare for and lead team meetings. Recognize when others need to be brought into the conversation and escalate appropriately. Expand on the ideas of peers or team member.
Perform other related duties incidental to the work described herein.
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Required: 1.Completion of a Bachelor's degree 2.Completion of an Associates degree plus a minimum of two years relevant experience (e.g., research, clinical, interaction with study population, program coordination)
OR ANY OTHER EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description
Required 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.
Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
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.