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.

Occupational Summary

Participate in or lead day to day operations of clinical research studies conducted by principal investigator(s) at Duke Health; perform a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data. May oversee the work of junior staff and train or mentor others in clinical research tasks.

Work Performed

Research Operations.

Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and standard operating procedures (SOPs).

Screen participants for complex studies (e.g., procedural and interventional studies). Develops or helps develop SOPs.

Employs and may develop strategies to maintain recruitment and retention rates and evaluate processes to identify

problems.

Escalates issues.

Conducts and plans for visits for complex studies (e.g., procedural and interventional studies).

Maintains participant level and study level documentation for all studies, including those that are complex in nature and/or require access to the Duke electronic health record (EHR).

Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings.

Is responsible for all aspects of managing and documenting Investigational Product (IP); including arrival, storage,

tracking, and provision to research participants.

Serves as the primary liaison with sponsors, Investigational Drug Service (IDS), and other parties as necessary. Follows protocol schema for randomization and blinding/unbinding.

Collects, prepares, processes, ships, and maintains the inventory of research specimens, primarily those requiring

complex procedures.

May maintain study level documentation for international studies and develop resources and tools for management of international studies, and/or coordinate with other entities or offices.

May prepare Federal Drug Administration (FDA) regulatory submissions in collaboration with Office of Regulatory Affairs and Quality (ORAQ), including development, submission, and maintenance ofrelevant

documentation.

Addresses FDA review and/or potential hold issues in collaboration with the Principal Investigator (PI).

Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties.

Leads meetings that are multidisciplinary, including those with complex objectives. Safety and Ethics.

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.

Data.

Enters and collects data, and 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.

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 research data security plans (RDSPs) for multiple study protocols.

Maps a protocols data flow plan including data capture, storage, transfer, management, quality, and preparation for analysis (may include data from EDCs, EHR, mobile apps, etc.).

Independently uses and implements technology to enhance productivity or process. Scientific Concepts.

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.

Site and Study Management.

Collects appropriate information to determine whether the study teams participation in a specific trial is feasible. May make feasibility recommendations.

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. Prepares for, coordinates, and actively participates in site visits.

Communicates effectively with sponsors and/or contract research organizations (CROs).

For studies with complex supplies or equipment, ensures that there are ample supplies and that equipment is in good working order.

May forecast staffing needs.

Uses systems and system reports to manage research participants activities and charge routing. Prepares studies for closeout and document storage.

Leadership and professionalism.

May train or oversee others in the above tasks. 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.

Uses advanced subject matter expe1tise in the therapeutic area or clinical research to solve problems.

Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently.

May serve on committees and workgroups internal to Duke or externally in therapeutic area of research. Demonstrates resilience and is adaptive to change.

Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.

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.