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Posted 4/14/21

Duke Global Digital Health Science Center
Clinical Research Coordinator

Job Summary

Participate in or lead day-to-day operations of clinical research studies conducted by Duke Global Digital Health Science Center; perform a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data.

Note: This is a 1-year grant-funded position, contingent upon continued funding.

Work Performed

  1. Research Operations (20%)
  • Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and standard operating procedures (SOPs).
  • Screen, enrolls and supports participants for complex studies.
  • Helps develop SOPs.
  • Employs and may develop strategies to maintain recruitment and retention rates and evaluate processes to identify problems.
  • Conducts and plans for visits for complex studies.
  • Maintains participant level and study level documentation for all studies, including those that are complex in nature and/or require access and comfort with the Duke electronic health record (EHR), and research management systems such as iRIS (IRB system), OnCore, REDCap, and study-specific sites.
  • Collects, prepares, processes, ships, and maintains the inventory of research specimens, primarily those requiring complex procedures.
  1. Safety and Ethics. (10%)
  • 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 Institutional Review Board (IRB) review. Communicates with the IRB staff and reviewers and handle issues appropriately. 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.
  • Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies.
  • Responsible for adherence to clinical research policies to ensure ethical conduct and protect vulnerable populations.
  • Communicate to research participants the difference between clinical activities and research activities, and the risks and benefits of study participation.
  1. Data (25%)
  • Enters and collects data, and develops data entry or collection SOPs or tools.
  • Ensures accuracy and completeness of data for all studies.
  • Recognizes data quality trends and escalates as appropriate.
  • Recognizes and reports security of physical and electronic data vulnerabilities.
  • Independently uses and implements technology to enhance productivity or process.
  1. Scientific Concepts (30%)
  • Assists with or contributes to the development of funding proposals.
  • Using scientific proposals from the PI, develops research protocols.
  • Demonstrates a basic understanding of the elements of research study designs.
  • Independently conducts literature searches and reviews.
  • Contributes to the development of scientific publications or presentations and serves as an author on poster presentations or publications.
  1. Site and Study Management (10%)
  • Ensures that studies are conducted in compliance with institutional requirements and other policies.
  • Follows protocol-specific systems and documents including process flows.
  • Prepares for, coordinates, and actively participates in site visits.
  • Communicates effectively with sponsors and/or contract research organizations (CROs).
  • Prepares studies for closeout and document storage.
  1. Leadership and professionalism (5%)
  • 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.
  • Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently.
  • Demonstrates resilience and is adaptive to change.
  • Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.

Education & Experience

  • Minimum qualifications: Associates Degree; BA/BS preferred (Public health, public policy, etc)
  • Clinical research coordination position experience (minimum 2 years); preferably working at Duke in public health, behavioral science, and/or nutrition fields
  • A Bachelor’s degree may substitute for 2 years required experience.

Key Skills

  • Excellent interpersonal and communication skills with a variety of constituents (e.g. research participants, community members, and research team members/collaborators)
  • Outstanding writing skills and ability to effectively collaborate with others to write grants and peer-reviewed publications
  • Strong organizational skills, clear and consistent research documentation, attention to detail and an ability to multitask
  • Ability to balance successful independent work with team collaboration
  • Sound decision-making skills that align with research goals and protocols; critical thinking skills and judgment; timely communication of barriers and deviations from protocol
  • Outstanding data management skills
  • Flexibility to work occasional evenings and/or weekends
  • High level of comfort and demonstrated competence with technology

To apply, please email cover letter and CV/resume to ddh_admin@duke.edu

Persons of color and/or from underrepresented groups/identities are strongly encouraged to apply.

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.