CLINICAL RESEARCH COORDINATOR

• Identify when MTAs, CDAs, DUAs, DTAs, and similar agreements are needed and communicate with the appropriate teams.
• Support or prepare FDA regulatory submissions in partnership with ORAQ, including development, submission, maintenance, and followup on review or hold issues.
• Apply knowledge of institutional and regulatory processes in protocol submissions, documentation, and SOP development.
• Manage investigational product (IP), including receipt, storage, tracking, and participant provision.
• Serve as liaison with sponsors, IDS, and external collaborators.
• Follow randomization and blinding/unblinding procedures.
• Support international study management and documentation as needed.
• Prepare for and support monitoring visits and audits, addressing findings promptly.
• Maintain all participant and study-level documentation for greaterthanminimal risk or complex studies.
• Develop and implement recruitment and retention strategies; escalate issues as needed.
• Screen participants for highcomplexity studies.
• Develop SOPs and manage human specimen collection, processing, shipment, and inventory.
• Conduct protocol-compliant study visits and contribute to effective team meetings, occasionally leading multidisciplinary discussions.

• Identify AEs, determine reportability, and assess relatedness with the PI.
• Conduct and document informed consent for greaterthanminimal risk studies, including those requiring Maestro Care orders.
• Develop consent forms and plans; submit IRB documentation through iRIS and respond to reviewer feedback.
• Prepare regulatory and safety submissions for sponsors and agencies.
• Ensure ethical conduct with special attention to vulnerable populations.
• Communicate clearly about the differences between clinical care and research participation.

• Enter and collect data; develop SOPs and tools to support data workflows.
• Train and oversee staff performing data entry or collection.
• Ensure data accuracy and escalate quality concerns.
• Develop QA tools and support adherence to security standards for electronic and physical data.
• Develop or review data lifecycle plans and map workflow from capture to analysis and sharing.
• Apply open science practices and FAIR principles.
• Prepare datasets for repository submission and assist with datasharing plans.
• Prepare tables, visualizations, lay summaries, and progress reports for PIs and stakeholders.
• Support qualitative or statistical analysis using tools such as SAS, R, SPSS, NVivo, or Atlas.ti.

• Assist with funding proposal development.
• Conduct literature searches and reviews.
• Contribute to protocol development, using PI scientific proposals as a framework.
• Support scientific manuscripts, posters, and presentations as an author or contributor.

• Prepare for and participate in site visits; communicate effectively with sponsors and CROs.
• Use OnCore, eREG, Maestro Care, and clinical research management systems to manage visits, calendars, finances, and participant activities.
• Evaluate study feasibility and provide recommendations.
• Ensure supply and equipment needs are met; may forecast effort requirements.
• Maintain compliance with institutional and studyspecific policies.
• Develop and follow operational plans, workflows, and documents.
• Prepare studies for closeout and manage document archiving.

• Train or oversee junior staff.
• Pursue ongoing professional development through Research Wednesdays, RPN events, and other offerings.
• Share knowledge with team members and participate in internal or external committees.
• Navigate Duke's research environment effectively, demonstrating strong collaboration, adaptability, and resilience.
• Use subjectmatter expertise to troubleshoot challenges and meet shared objectives.

• Associate's degree required.

• Minimum of two years of relevant research experience.
• Completion of the DOCR North Carolina stateapproved Clinical Research Apprenticeship Program may substitute for one year of experience.

• Proficiency with computing software and webbased applications, including Microsoft Office and common browsers.

• As applicable per study or departmental requirements.

Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $59,829.00 to USD $99,960.00. 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.