CLINICAL RESEARCH COORDINATOR
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.
The Department of Family Medicine and Community Health in the Duke University School of Medicine is dedicated to improving the health of people in their communities. Duke Family Medicine and Community Health's diverse group of full-time researchers, as well as clinical faculty, are actively engaged in a wide variety of disciplines with research encompassing a broad collection of clinical, community and population health research programs, drawing on an eclectic set of analytical methods and tools. Department researchers collaborate extensively with community partners and clinicians across the Duke University School of Medicine, Duke’s three campuses (Durham, Singapore and Kunshan), and beyond.
The Clinical Research Coordinator (CRC) will be involved in a wide range of study activities. CRC will lead, coordinate, and perform a variety of complex independent and team activities involved in the collection, analysis, documentation and interpretation of social, economic or health-related research information and data.
Development of data collection strategies, including helping to design and administer surveys/questionnaires, creating interview structures and conducting in-person and virtual interviews, and carrying out desk-based research. Data synthesis and analysis of qualitative and quantitative data collected. Data management and analysis of big quantitative data sets (data may be from Electronic Health Records (EHR) using statistical software packages (ie. SAS or STATA). Enters and collects data. Develops qualitative data management strategies using software (ie. NVivo). 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. Recognizes and reports security of physical and electronic data vulnerabilities. May develop or review RDSPs for multiple study protocols. 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. May train or oversee others.
Knowledgeable of regulatory and institutional policies and processes and applies these appropriately in development of study documentation, protocol submissions, and SOPs. May train others in these policies and processes. Maintains study level documentation for international studies. May develop resources and tools for management of international studies, and/or coordinate with other entities or offices. Under supervision, assists with managing investigational products including arrival, storage, and handling (requisitions, inventory, and reordering). Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings. 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. Follows SOPs and strategies to manage and retain research subjects. Recruits research participants according to study protocol. Screens participants in person or over the phone for non-complex studies (e.g., questionnaire, data registry, scripted) or may collect information from the EHR to assist study team in determining eligibility. Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). Schedules participants for research visits (excluding those requiring EHR access). Prepares necessary documents, equipment, supplies, etc. Conducts and documents non-complex visits and scripted testing or interviews. May manage participant payment. Leads meetings that are multidisciplinary, including those with complex objectives.
Develops consent plans and documents for participants in a variety of studies. May train or oversee others. Develops and submits documentation and information for IRB review. Communicates with the IRB staff and reviewers and handles issues appropriately. May train or oversee others. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. May train or oversee others. Identifies all adverse events (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. May train or oversee others.
Independently conducts literature searches and reviews. Using scientific proposals from the PI, develops research protocols. Demonstrates a basic understanding of the elements of research study designs. Provides some contribution to scientific publications or presentations.
Study and Site Management:
As directed, attends or schedules site visits. Uses clinical research management system and its reports to manage research participants' activities, including minimum footprint, calendars, tracking/marking financial milestones, and all aspects of study visits. May train others. For studies with simple supplies or equipment, ensures 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 protocol-specific systems and process flows. As directed, assists in preparing studies for closeout, (e.g., packing files, documenting files for storage, shipping extra supplies back to sponsor).
Maintains Duke and project specific training requirements. Keeps current with research updates by attending key external departmental meetings (i.e. Research Wednesday, Research Practice Network, additional training, etc.). Demonstrates interpersonal skills to get work done efficiently. Recognizes and escalates organizational issues that could be optimized to improve research process. Demonstrates resilience and is adaptive to change. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems. Communicates with other study personnel as required for study implementation and routine problem resolution.
Type of Research:
This individual will work with complex studies and simple studies, and will include studies that are minimal risk and some that may be more than minimal risk. Research studies maybe be quantitative, qualitative, or mixed-method. This individual will work with the management of some study site-specific team members. This person’s primary work will be IRB work, minimum footprint, participant interactions/contact, and data entry and collection.
Management of multiple priorities; organizational skills; communication/writing skills; prior experience in clinical trials is desired due to the independent nature of the work; can easily use computing software and web-based applications. Spanish language skills a plus, but not required.
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.
Preferred Qualifications: Master’s or advanced degree in a discipline of global health, public health, epidemiology, or related fields.
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.