Clinical Research Coordinator - Psychiatry - Behavioral Med Division - Sweitzer Lab

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.

Occupational Summary:

Participates in or leads day to day operations of clinical research studies conducted by principal investigator Dr. Maggie Sweitzer in the Department of Psychiatry and Behavioral Sciences at Duke North Pavilion; performs 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.

The primary objective of the PRISM.02 study (Pain Response Imaging in Smoking) is to determine the neural basis and day to day behavioral impact of smoking withdrawal-induced hyperalgesia (pain) among people who smoke with and without chronic back pain. As a CRC working on this study, you will be responsible for regulatory and administrative tasks, as well as proper documentation and study procedures for participants starting at screening and through study completion. Some study procedures that you will be responsible for are: recruitment, screening, participant scheduling and communication, consenting, administering pain stimuli (e.g., heat) under carefully controlled conditions, assisting with fMRI sessions, administering surveys and questionnaires, documentation on paper and in REDCap (EDC), documenting adverse events, maintaining enrollment logs, maintaining and ordering equipment, assisting with other studies, as well as other tasks and responsibilities.

Work Performed:

• Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and standard operating procedures (SOPs).
• Prepares for and provides support for study monitoring and audit visits (CQMP), including support for the reviewer. Addresses and corrects findings.
• Maintains participant level and study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies) and require access to the Duke electronic health record (MaestroCare).
• Employs and may develop strategies to maintain recruitment and retention 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.
• Collects, prepares, processes, ships, and maintains the inventory of human research specimens, primarily those requiring complex procedures.
• Conducts activities for study visits in compliance with the protocol.
• Contributes to the effective facilitation of team meetings to achieve predetermined objectives. May lead multidisciplinary meetings with various stakeholders.
• Identifies all AEs, and reports to PI or MPI in timely manner.
• Conducts and documents consent for participants for all types of studies.
• 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.
• 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.
• Communicates the difference between clinical activities and research activities, and the risks and benefits of study participation to research participants.
• 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, 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 data lifecycle and management plans 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.).
• Innovatively uses technology to enhance a research process.
• Prepares tables, data visualizations, and lay summaries to communicate study results to participants.
• Develops reports on study progress for the PI and other study team members and collaborators. Creates clear visualizations to help communicate key information to stakeholders.
• Assists with or contributes to the development of funding proposals.
• Independently conducts literature searches and reviews.
• Demonstrates and applies a basic understanding of open science practices and the FAIR data principals.
• Using scientific proposals from the PI, develops elements of research protocols.
• Demonstrates a basic understanding of the elements of research study designs.
• Contributes to the development of scientific publications or presentations and serves as an author on poster presentations or publications.
• Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and contract research organizations (CROs).
• Uses clinical research management system and its reports to manage research participants activities, calendars, tracking and 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. May make feasibility recommendations.
• For studies with supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. May forecast effort needs.
• Ensures that studies are conducted in compliance with institutional requirements and other policies.
• Follows, and may develop or implement, operational plans (e.g. protocol specific systems and documents including process flows).
• Prepares studies for closeout and document storage.
• 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. May serve on committees and workgroups internal to Duke or externally in therapeutic area of research.
• 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.
• 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.
• Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).
   

Minimum Qualifications

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunities 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.

Anticipated Pay Range

Duke University provides an annual base salary range for this position as USD $58,656.00 to USD $98,000.00. Duke University considers factors such as (but not limited to) the 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: Duke 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 of 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.