Clinical Research Coordinator

Be You.

This full-time onsite Clinical Research Professional (CRP) will serve as the primary coordinator for assigned clinical research studies and will support the Lead in managing the study portfolio for research conducted by the Division of Endocrinology in the Department of Medicine under the supervision of the Principal Investigators (PIs). The CRP will be responsible for a broad range of clinical research activities, including participant recruitment, screening, informed consent, enrollment, coordination and conduct of study visits, maintenance of study and site documentation, and data entry. All activities will be conducted in compliance with sponsor, regulatory, and institutional guidelines. Other tasks include EMR review, collection/processing/shipment of research specimen, investigational product (IP) management, query resolution, participant payment processing, workflow coordination and ongoing communication with investigators, sponsors, and organizational leadership. The ideal candidate will be highly organized, detail-oriented, and adaptable, with demonstrated ability to manage multiple priorities and stakeholders independently. Prior Duke clinical trial experience is preferred. This position will report to the CRC, Sr.. The PIs 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 appropriately in study documentation, protocol submissions, and SOPs. May train others in these policies and processes. 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 basic data for research studies. May score scripted or validated tests and measures. 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 protocol-specific systems and process flows. 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. Demonstrates interpersonal skills to get work done efficiently. Recognizes and escalates organizational issues that could be optimized to improve research process. 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.

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