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 sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Operations:

• Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs.
• Managing and documenting Investigational Product (IP); including arrival, storage, tracking, and provision to research participants.
• Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. 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.
• Employ strategies to maintain retention rates.
• Screens participants for complex studies (e.g., procedural and interventional studies).
• Develops or helps develop SOPs.
• Collects, prepares, processes, ships, and maintains the inventory of human research specimens, primarily those requiring complex procedures.
• Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies).
• Conducts activities for study visits in compliance with the protocol.
• Participates in study team meetings.
  
  Ethics:
  
  
• Identifies all AEs, and determines whether or not they are reportable. Collaborates with the PI to determine AE attributes, including relatedness to study.
• 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. Develops consent plans and documents for participants in a variety of studies.
• Develops and submits documentation and information for IRB review. Communicates with the IRB staff and reviewers and handles issues appropriately. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies.
  
  Data:
  
  
• Enters and collects data.  Develops data entry or collection SOPs or tools.
• Independently responds to queries created by a CRO or the data manager. Ensures accuracy and completeness of data for all studies, including those that are complex in nature.
• Recognizes data quality trends and escalates as appropriate.
• 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.).
• Innovatively uses technology to enhance a research process.
• Assists in updating and may develop reports on study progress for the PI and other study team members and collaborators..
  
  Science:
  
  
• Assists with or contributes to the development of funding proposals. Independently conducts literature searches and reviews. Independently, using scientific proposals from the PI, develops elements of research protocols for complex investigator-initiated studies, across multiple PIs or study teams.
• Uses expertise in research design to provide significant contribution to protocols or research proposals. Contributes to the development of scientific publications or presentations.  Serves as an author on poster presentations or publications.
  
  Study and Site Management:
  
  
• Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or CROs.
• Uses clinical research management system and its reports to manage research participants' activities, calendars, tracking/marking financial milestones, and all aspects of study visits.
• Uses required EMR functionalities to manage participants and study visits.
• 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.
• Collects appropriate information to determine whether the study team's participation in a specific trial is feasible.
• For studies with supplies or equipment, ensures that there are ample supplies and that equipment is in good working order.
• Ensure that studies are conducted in compliance with institutional requirements and other policies. Follow, and may develop or implement, operational plans (e.g. protocol-specific systems and documents including process flows).
• Prepares studies for closeout and document storage.

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.
• 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.
• Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.
  
  
  Type of Research:
  This position will support the research portfolio of the Lung Transplant Program which includes industry-funded investigational drug studies, multicenter prospective observational longitudinal studies funded by the NIH and private foundations, as well as internally funded investigator-initiated research projects.
  
  Special skills:
  Prior research experience in the field of Pulmonary medicine, proficiency in medical terminology, EPIC, iRIS, OnCore and REDCap are preferred

Duke University provides an annual base salary range for this position as USD $ 59,829.00 to USD $99,960.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer.

Your total compensation goes beyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at: https://hr.duke.edu/benefits/

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job 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.

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 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 (including pregnancy and pregnancy related conditions), sexual orientation or military status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends onthe 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 essential job 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.