Clinical Research Coordinator

Duke School of Nursing

• School of Nursing Established in 1931, Duke University School of Nursing is among the top-ranked nursing schools. The school is proud of its overarching commitment to educating the next generation of nurse leaders and advancing the role of nurses and nursing in the transformation of health care and in the expansion of health equity. The School of Nursing has an inclusive and diverse community that supports the professional goals of its students, faculty, and staff as they pursue excellence. Comprised of 1,600 faculty, staff, instructors, and students, the Duke University School of Nursing, Duke University School of Medicine, and Duke University Health System are a part of Duke Health. The Duke University Health System is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a network of health services. It encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Health Integrated Practices, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations
• Duke University Health System was awarded the American Board of Nursing Specialties Award for Nursing Certification Advocacy for being strong advocates of specialty nursing certification.
• Duke University Health System has 6000 + registered nurses
• Quality of Life: Living in the Triangle!
• Relocation Assistance!

OCCUPATIONAL SUMMARY

This full-time position includes 100% effort to work on research studies focused on addressing the needs of English- and Spanish-speaking patients with traumatic brain injury (TBI) and family caregivers during the transition home from acute hospital care. The candidate selected must be fluent in speaking, reading, writing, and comprehending English and Spanish. This position involves work on a research study that is funded by the National Institutes of Health with internal funding supporting the position. This position is term-limited for a 1-year period. Consideration to offer an extension to the term will be contingent upon the needs of the department.  This team member will work closely with the Principal Investigator and study team members to implement study protocols with main roles to include screening, recruiting, conducting study visits, data collection, data entry, and data analysis. This position is partially remote apart from occasional study visits and recruitment events on assigned days, which may be conducted within the community and will require travel within the research triangle area. Additionally, this position may require work in the evenings and/or weekends on a rotating basis.

WORK PERFORMED

1.  Operations

• Daily screening of the electronic medical record of patients hospitalized with TBI to determine eligibility to participate.
• Conduct longitudinal data collection and lead individual interviews with participants in English and Spanish.
• Translation and backtranslation of study materials from English to Spanish.
• Coordination with other study team members and DUHS healthcare providers.
• Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties.
• Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs. May train others in these policies and processes.
• Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings. May train others.
• Maintains participant level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies) and/or require access to the Duke EHR. May train or oversee others.
• Employ strategies to maintain retention rates. Evaluates processes to identify problems with retention.
• Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems. Escalates issues.
• Screens participants for complex studies (e.g., procedural and interventional studies).
• Develops or helps develop SOPs. Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies).
• Conducts and plans for complex study visits. May train staff.
• Leads meetings that are multidisciplinary, including those with complex objectives.

2. Ethics  

• Identifies all AEs and determines whether or not they are reportable.  Collaborates with the PI to determine AE attributes, including relatedness to study. May train or oversee others.
• Conducts and documents consent for participants for all types of studies, including those that are complex in nature and/or require any orders in Maestro Care.
• Assists with the development of consent plans and documents for participants. Develops and submits documentation and information for IRB review. Communicates with the IRB staff and reviewers and handles issues appropriately. 

3. Data

• Enters and collects data.  Develops data entry or collection SOPs or tools. May provide oversight or training to study team members collecting or entering data.
• Ensures accuracy and completeness of data for all studies, including those that are complex in nature. Recognizes data quality trends and escalates as appropriate.
• May develop tools for, and train others in, data quality assurance procedures. Follows required processes, policies, and systems to ensure data security and provenance.  In addition, recognizes and reports security of physical and electronic data vulnerabilities.
• Maps a protocol's data flow plan including data capture, storage, transfer, management, quality, and preparation for analysis (may include data from EDCs, EHR, mobile apps, etc.). May train or oversee others.
• Independently uses and implements technology to enhance productivity or process. 
• Runs and maintains accurate documentation of randomization scheme.

4. Science

• Independently conducts literature searches and reviews. Synthesizes and categorizes literature obtained from searches and reviews. Demonstrates a basic understanding of the elements of research study designs.
• Contributes to the development of scientific publications or presentations.  Serves as an author on poster presentations or publications.
   

5. Study and Site Management

• Records participant accrual information and consent documentation for complex behavioral intervention studies in clinical research management system.
• Uses clinical research management system and its reports to manage all protocol activities, including minimum footprint, SIP counsel, and all aspects of maintaining current protocol information. May train others.
• For studies with simple supplies or equipment, assists with ensuring that there are ample supplies and that equipment is in good working order.
• Ensures that studies are conducted in compliance with institutional requirements and other policies.
• Follows, and may develop or implement, protocol-specific systems and documents including process flows. May train or oversee others.
• Prepares studies for closeout and document storage.

6. Leadership

• Proactively seeks opportunities to add relevant skills and certifications to own portfolio. Keeps current with research updates by attending key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.) and applies the learned material to the job. May disseminate information to others.
• Serves on committees and workgroups internal to Duke or externally in therapeutic area of research.
• Navigates processes and people involved in Duke clinical research, demonstrates organizational awareness, and has the interpersonal skills necessary to get work done efficiently.
• Demonstrates resilience and is adaptive to change.
• Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems.
• Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.
   

7. Miscellaneous

• Complete and process subject payment forms.
• Follow Duke procedures in regard to collecting Data Disclosure forms and requirements around SSN# storage and payment processing.
• Perform other related and requested duties incidental to the work described herein.

DEPARTMENTAL PREFERENCES

Education/Training

1. Completion of a Bachelor's degree; OR

2. Completion of an Associate’s degree plus a minimum of two years relevant experience (e.g., research, clinical, interaction with study population, program coordination).

Experience

Experience working on randomized controlled trials is preferred.  

Experience working with health-related care of patients or clinical research studies is preferred. 

Skills

• Must be fluent in Spanish and English (speaking, reading, writing, and comprehension). 
• Can easily assist with qualitative and quantitative data collection and analysis. 
• Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers). 
• Proficiency with use of REDCap, Qualtrics, and Nvivo is preferred.

MINIMUM QUALIFICATIONS

Education

Completion of an Associate's degree

Experience

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.