Be You.

The Research to Eliminate Global Cancer Disparities (REGAL) team aims to understand and address the underlying causes of cancer health disparities in the US and globally. We evaluate the relative and joint contributions of social determinants of health (e.g. healthcare access, socio-economic status, systemic racism) and molecular mechanisms that drive cancer mortality. Leveraging robust data from primary and secondary sources, high-quality biospecimen and molecular assay data, we utilize a cell to society framework to identify key factors that can be modified to eliminate racial disparities in cancer. The REGAL team includes junior faculty, post-docs, biostatisticians, project coordinators and grad students.

Minimum Requirements:

Completion of an Associate’s Degree.

Work requires a minimum of two years of relevant research experience. Completion of the DOCR North Carolina state approved Clinical Research Apprenticeship program may substitute for one year of required experience. A Bachelor's degree may substitute for 2 years required experience.

Preferred Qualifications:

Master’s degree such as MPH with minimum of 2 years of population health research experience is strongly preferred. Experience with cancer disparities research is strongly preferred. Fluency in both English and Spanish is preferred. Prior experience in biospecimen collection, processing and management is highly preferred (e.g. Blood and tissue collection, preservation and aliquoting). Advanced knowledge in building and maintaining databases using data collection software (e.g. REDCap, Qualtrics) is highly preferred.

Skills:    

• Can easily use computing software and web-based applications (e.g., Microsoft Office products, Zoom and internet browsers).
• Efficient in using data collection software (e.g.,REDCap, Qualtrics), Efficient in using data analysis software (e.g., SAS, R).
• Skilled in biospecimen collection, processing and management (e.g. Blood and tissue collection, preservation and aliquoting).
• We are looking for knowledgeable, proactive, dynamic, and results-oriented individual to join our team.

Be Bold.

Position Description:

The REGAL team seeks a Clinical Research Coordinator Scientist to perform a variety of research and program management duties to support our cancer research program. They will:

• 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.

*Occasional weekend/evening work is needed.*

They will work under the direction of a Research Program Leader (RPL) or similar Clinical Research Unit (CRU)/Oversight Organization (OO) designee.

Work Responsibilities:

Research Operations

• Experienced in developing SOPs and protocols for research studies.
• Highly knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and standard operating procedures (SOPs).
• Develops strategies to maintain recruitment and retention rates and evaluate processes to identify problems and develops innovative solutions.
• 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).
• Under supervision, prepares for and provides support for study monitoring and audit visits, including support for the reviewer.
• Responsible for all aspects of managing and documenting study materials; including arrival, storage, tracking, and provision to research participants.
• Highly experienced in collecting, preparing, processing, shipping and maintaining the inventory of research specimens such as blood, saliva and tissue samples.
• 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

• Highly experienced in developing consent plans and documents for participants in a variety of studies.
• Conducts and documents consent for participants in non-complex studies. These are typically repositories, survey studies, simple observational studies, non-patient studies that do not involve investigational products or devices.
• 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.

Data

• Enters and collects data and develops data entry or collection SOPs or tools. Provides 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.
• Highly skilled in developing 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.
• Prepares reports for monitoring study progress.

Scientific Concepts

• Demonstrates a deep 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

• 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.
• For studies with simple supplies or equipment, ensures that there are ample supplies and that equipment is in good working order.
• Records participant accrual information and consent documentation for non-complex studies in clinical research management system.
• Uses systems and system reports to manage research participants activities.
• As directed, assists in preparing studies for closeout.

Leadership and professionalism

• May train or oversee others in the above tasks. Proactively seeks opportunities to add relevant skills and certifications to own portfolio.
• Works with the manager to understand areas of opportunity and develop training plan. Takes training courses and applies the knowledge and skills. May also train others in the skills learned.
• Keeps current with research updates by attending key external offerings (i.e. Research Wednesday, events outside of Duke, etc.) and applies the learned material to the job. May disseminate information to others.
• Navigates processes and people involved in Duke clinical research, demonstrates 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.
• Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems.

Choose Duke.

Join our award-winning team as identified by Forbes magazine as America’s Best Large Employer 2024 and be part of an inclusive culture that values excellence, innovation, and discovery. As an organization, we have exciting opportunities to be forward-thinking leaders in our field. We want talented individuals to join us, examine our current operations, and create innovative solutions that will revolutionize and enhance the way we approach our work.

Duke University is consistently ranked among the top universities worldwide and is renowned for its cutting-edge research across disciplines.

Beyond the engaging work, you'll also benefit from Duke's competitive benefits package including health insurance plans, generous paid time off, retirement programs with employer contributions, tuition assistance for employees and their children, and more.

Diversity Statements:

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.