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.
Be You.

This full-time onsite Clinical Research Professional (CRP) will participate in research conducted by the Division of Gastroenterology in the Department of Medicine under the supervision of the Principal Investigators (PIs) of the Gastroenterology Research Program. This CRP will perform a variety of research and duties including consenting, enrollment, conducting subject visits, study and site documentation, data entry etc in compliance with sponsor, regulatory, and institutional guidelines, collaborating with physicians and nurses/clinic staff to obtain the specimen, processing/management/shipment of samples to support the conduct of clinical research. Other tasks may include EMR review, participant screening, IP management, query resolution and participant payment processing. The CRP will be integrated into a larger clinical research team and is expected to collaborate on studies that will further the research mission of the Gastroenterology program. This position reports to the CRC Sr..The Principal Investigators will provide supervision, regulatory oversight, mentorship, and guidance in the conduct of research.

Minimum Requirements:

Education/Training

Completion of an Associate's degree

Experience

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.

Skills

Can easily use computing software and web based applications (e.g., Microsoft Office products and internet browsers).

This position is:

• Onsite

Be Bold.

As a Clinical Research Coordinator you will participate in or lead day to day operations of clinical research studies conducted by Principal Investigator(s) (PI) 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.

What You'll Do:

Operations: Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. Prepares FDA regulatory submissions in collaboration with ORAQ, including development, submission, and maintenance of relevant documentation. Addresses FDA review and/or potential hold issues in collaboration with the Principal Investigator (PI). May train or oversee others. Knowledgeable in regulatory and institutional policies and processes. Applies knowledge to assist with study documentation, protocol submissions, and standard operating procedures (SOPs). Assists with study level documentation and approvals for international studies. 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, IDS, and other parties as necessary. Follows protocol schema for randomization and blinding/unblinding. May train others. Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings. May train others. Maintains all participant level documentation for studies that are greater than minimal risk or complex in nature (e.g., procedural and interventional studies). May train or oversee others. Employs strategies to maintain retention rates. Evaluates processes to identify problems with retention. May train or oversee others. Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems. Escalates issues. May train or oversee others. Screens participants for greater than minimal risk or complex studies (e.g., procedural and interventional studies). May train or oversee others. Develops or helps develop SOPs. May train or oversee others. Collects, prepares, processes, ships, and maintains the inventory of human research specimens, primarily those requiring complex procedures. May train or oversee others. Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). May train or oversee others. Conducts activities for study visits in compliance with the protocol. May train staff. Contributes to the effective facilitation of team meetings to achieve predetermined objectives. May lead multidisciplinary meetings with various stakeholders.

Ethics: Identifies all AEs, and determines whether or not they are reportable. Collaborates with the PI to determine AE attributes, including relatedness to study. May train or oversee others. Conducts and documents consent for participants for all types of studies, including those that are greater than minimal risk or complex in nature and/or require any orders in Maestro Care. May train or oversee others. Develops consent plans and documents for participants in a variety of studies. May train or oversee others. Develops and submits documentation for IRB review in iRIS. 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. May train or oversee others.

Data: Enters and collects research data. Develops research data entry or collection tools. May provide oversight or training to study team members collecting or entering research data. Ensures accuracy and completeness of data for all studies, including those that are greater than minimal risk or 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. Demonstrates and applies open science practices and the FAIR data principles. Prepares data for deposit in repositories following publication or study closeout. Locates and follows repository-specific requirements to submit study data for sharing. May draft data sharing plans for clinical studies that ensure data and documentation will support re-use. Maps a protocol's data workflow including data capture, storage, transfer, management, quality, and preparation for analysis (may include data from EDCs, EHR, mobile apps, etc.). May train or oversee others. Innovatively uses technology to enhance a research process. May train others. Prepares tables, data visualizations, and lay summaries to communicate study results to participants. 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. Develops elements of research protocols using scientific proposals from the PI. Demonstrates a basic understanding of the elements of research study designs. 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 of financial milestones, and all aspects of study visits. Uses required EHR functionalities to manage participants and study visits. May train others. Uses OnCore and eREG systems and system reports to manage research protocols. May train or oversee others. 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. May train or oversee others. Ensure 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). May train or oversee others. Prepares studies for closeout and document storage. May train or oversee others.

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. Serves 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.

Choose Duke.

Use your college/unit or department as a selling point. Think about the "what's in it for me" candidate viewpoint. You do not need to include everything, just the most attractive parts of working for your college/unit or department. Keep this section concise for effectiveness - in general, try to limit it to 1-2 paragraphs.

Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $61,026.00 to USD $101,959.00. 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 goesbeyond 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:

Equal Opportunity Employer: 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 oncollaboration, 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 essential job functions that require specific physical and/or mental abilities. Additional information and reasonable accommodation(s) can be requested with Duke Access and Accommodations Services (email: [click to reveal email address] View email address on us.fitly.work ; phone: [click to reveal phone number]View phone number on us.fitly.work).