Clinical Research

• Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity
• Oversees site interactions post activation through site closeout
• This may include patient recruitment, investigator payments or other related activities
• May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT)
• Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/CeMs) is aware of the contractual obligations and parameters
• Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables
• Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope
• Employs strategic thinking and problem-solving skills to propose and implement risk mitigations
• Participates and presents in key meetings such as Kick Off Meeting
• Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members
• Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines
• Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities
• Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan
• Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed
• Ensures access and audit trail reviews are conducted as required
• Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study
• Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality
• Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools
• Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan
• Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan
• Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans
• Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity
• Document requested revisions and approvals in CTMS
• Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines
• Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables
• Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements
• Provides solutions for obstacles in protocol execution and site management
• Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations
• Supports Inspection Readiness for clinical trial management scope
• Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks
• Develop and support execution of corrective action plans at site and study level
• Supports and completes activities to achieve data cut and lock deadlines
• Provides feedback to line managers on staff performance including strengths as well as areas for development
• May be assigned to larger, more complex trials or may coordinate clinical activities for a team of CTMs across a portfolio of projects
• May coach and mentor CTMs regarding functional clinical delivery, evaluation of project risks, and action implementation

Clinical Trial Manager

• Works with Medical Director to develop medical plans (Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan)
• Performs regular and ad-hoc medical review of data listings and data visualization as needed
• Authors medical data queries and reviews query responses
• Partners with Medical Directors for medical data review meetings and safety review meetings
• Manages project scope of work, objectives, and quality of deliverables to ensure the project specific milestones and timelines are met
• Collaborates with study team members including Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management
• Attends and present at Trusted Process meetings

Clinical Scientist, Medical Monitoring – Oncology – Breast

• Lead health outcomes and health services research projects from concept through delivery, applying sound research design, statistical methods, and evidence-based approaches
• Translate complex clinical and analytical findings into clear, compelling manuscripts, presentations, reports, and other communications tailored to healthcare professionals, policymakers, patients, and business stakeholders
• Conduct literature reviews and background research to strengthen study design, support strategic recommendations, and provide context for research findings
• Partner with analytics, clinical, and cross-functional teams to answer important healthcare questions and evaluate the clinical and financial impact of products, programs, and services
• Analyze large healthcare datasets to generate actionable insights, identify trends, and support enterprise research priorities
• Serve as a project lead or key contributor across multiple initiatives, ensuring high-quality deliverables and timely execution
• Communicate research findings and recommendations to diverse audiences, helping stakeholders understand complex data and make informed decisions
• Contribute to a culture of innovation, continuous learning, and collaboration while adapting to evolving business needs

Senior Business Analytics Advisor – Clinical & Health Outcomes Research

• Independently negotiating and managing Clinical Trial Agreements (CTAs), CTA amendments, and site budgets for U.S. and Canadian clinical research sites
• Drafting, cloning, reviewing, and negotiating site-specific CTAs from approved country templates
• Leading contract and budget negotiations directly with investigative sites while partnering with Sponsor stakeholders until all issues are resolved
• Applying approved CTA fallback language and budget negotiation parameters with minimal supervision
• Maintaining accurate contract negotiation status and milestones within the Sponsor's clinical trial tracking system
• Preparing amendments, revised budgets, and supporting documentation throughout the study lifecycle
• Performing quality control reviews to ensure contracts are complete, accurate, compliant, and execution-ready
• Coordinating contract execution and maintaining all required documentation and metadata within electronic repositories
• Partnering closely with Clinical Operations, Site Start-Up, Finance, Legal, and Site Contract Service Center teams to ensure efficient study activation
• Identifying contractual or operational risks early and proactively driving solutions
• Tracking contracting timelines, deliverables, and project milestones to support study start-up goals
• Serving as a trusted point of contact for internal teams, investigative sites, and Sponsor stakeholders
• Supporting customer meetings, business initiatives, and continuous process improvements
• Mentoring junior team members and contributing to SOPs, training materials, and quality initiatives
• Monitoring contract-related project metrics and escalating issues when appropriate

Senior Site Contracts Specialist – Clinical Trial Contracts

• Lead end-to-end analytics initiatives from problem framing and experimental design through production delivery
• Architect and implement scalable data solutions
• Fuse disparate data sources and establish data preparation standards
• Implement data quality controls and manage schema changes
• Develop, evaluate, and deploy predictive models and optimization approaches
• Support text-heavy and unstructured-data use cases with NLP methods
• Deliver decision-support products through Power BI
• Provide technical leadership and consultation

Biostatistician

• Acquire, integrate, and prepare data from multiple sources to enable operational reporting, readiness analytics, and decision support.
• Design and implement ETL/ELT pipelines using SQL Server and Databricks leveraging Apache Spark (PySpark) for scalable batch processing and data transformation.
• Develop and maintain curated, analysis-ready datasets (e.g., dimensional models, governed reporting tables) with attention to data quality, lineage, and repeatability.
• Optimize data processing performance (partitioning strategies, efficient joins, job tuning) and contribute to reliable scheduling/orchestration and monitoring of recurring workloads.
• Apply statistical methods, data mining, and machine learning to generate actionable insights, forecasts, and predictive analytics relevant to military missions and readiness.
• Create dashboards and analytical products using Power BI, including semantic modeling and measures to support consistent metrics and reporting.
• Support low-code solutions by integrating data products into Power Apps (Canvas and Model-Driven) and automations using Power Automate.
• Contribute to text and language-focused use cases by preparing and analyzing unstructured data (basic NLP preprocessing, labeling/curation, feature creation).
• Demonstrate familiarity with LLMs and agent concepts (prompting patterns, retrieval-style workflows, evaluation considerations) and assist senior team members in implementing these capabilities where appropriate.
• Document data sources, transformations, assumptions, and analytical methodologies to ensure transparency and operational continuity.

Junior Biostatistician

• publish content on external website (dcri.org) and intranet (Pulse) using content management systems (Drupal and SharePoint, respectively)
• create graphics for social media, external websites, and intranet
• determine requirements for instructional audiovisual media and coordinate production of slide series, films, videotapes and other media materials for use
• works both independently and collaboratively with internal Shared Services department, Production Designers and Marketing Managers on a wide mix of creative initiatives
• manage calendar of DCRI’s scientific conferences, researching Duke-related presentations at each show
• for scientific conferences at which DCRI has an exhibit booth, coordinate the marketing collateral needed for the booth
• prepares layouts, designs, artwork and formats for use in publication and/or exhibition design
• contribute to editorial planning by suggesting content ideas, target channels and audiences, and appropriate project timelines
• compile weekly internal newsletter in MS Outlook
• create quarterly external-facing newsletters using Constant Contact
• occasional content development for DCRI-owned external and internal channels
• serve as backup manager of DCRI’s social media channels (Twitter and LinkedIn)
• assist in the shooting and production of video and audio projects
• develop a broad knowledge of research conducted at the DCRI

Clinical Research Comm Specialist III

• Step into a high ‑ impact, fully remote role managing critical industry sponsored clinical research grants and contracts!
• Manage critical industry sponsored clinical research grants and contracts.
• Ensure all applications and contracts meet sponsor/agency and university guidelines adhering to necessary internal and external deadlines.
• Manage assigned projects and financial project portfolios using independent judgment and discretion.
• Build and maintain close collaborative working relationships with Principal Investigators (PIs), key study personnel and colleagues throughout Duke.

Grants & Contracts Administrator – Clinical Research Administration Finance Post-Award

• Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans)
• Accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place
• Contribute to the development of the project risk mitigation plan. Manage clinical risks through the project lifecycle
• Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues
• Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver
• Monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out of scope work
• Work as the primary Clinical Lead alongside other Clinical Leads to deliver large, global trials
• Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management
• Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements
• Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings
• Conduct regular team meetings and communicate appropriately to achieve objectives
• Support professional development by providing feedback to clinical team line managers on performance relative to project tasks to support professional development
• Adopt corporate initiatives and changes and serve as a change advocate when necessary
• May contribute to the development of the clinical delivery strategy for business proposals. Participate in bid defense preparations and meetings
• Develop and present Clinical Operation plan in partnership with Business Development and Project Leadership
• May mentor and coach new peers as they assimilate into this role
• May attend site visits as applicable in support of project delivery

Senior Clinical Trial Manager

• Full accountability for country-level study delivery and performance
• Serve as the client’s voice within Civia, ensuring their priorities, timelines, and standards are understood and met across all functions
• Maintain disciplined oversight of start-up, recruitment, regulatory progress, data quality, and site performance
• Drive immediate cross-functional action when performance deviates from plan
• Lead structured governance routines with clarity, transparency, and solution orientation
• Ensure ongoing audit and inspection readiness across all study activities

• Develop medical plans and coordinates with Medical Directors
• Perform medical reviews of data listings
• Author and review medical data queries
• Manage project scope and quality of deliverables
• Collaborate with study team members to identify risks

Clinical Scientist – Immunology, Ulcerative Colitis, Crohn’s Disease, Rheumatology

• Partner cross-functionally with Project Management, Business Development, Commercial Finance, and Legal to ensure financial risks are identified and addressed early in the study lifecycle
• Establish and maintain operating mechanisms that improve visibility into study financial performance, including budget tracking, variance analysis, and risk forecasting
• Translate financial insights into actionable recommendations that influence operational and commercial decision-making
• Lead continuous improvement initiatives to enhance financial processes, reduce cycle times, and improve data quality and reporting consistency
• Drive accountability across stakeholders for financial performance
• Coordinate and oversee sponsor financial audits, ensuring compliance with contractual terms, regulatory expectations, and audit readiness standards
• Build, lead, and develop a high-performing, globally distributed finance team

Operations Finance Director – Clinical Research Central Laboratory

• Provide leadership and direction to clinical site management team members from study start through to closure
• Serve as Site Management’s primary point of contact and representative for clinical monitoring and site activities within the project, including, but not limited to Primary Sponsor Contact
• Manage monitoring deliverables to achieve the study budget and identify out-of-scope activities

Senior Clinical Trial Manager – CNS

• Drive the execution of Lilly clinical trials through exceptional investigator engagement and site performance management
• Ensure Lilly’s portfolio is prioritized at high-performing sites and that trials are delivered with quality, speed, and insight
• Combine deep therapeutic and scientific knowledge with strategic agility to influence investigators, elevate protocol understanding, and co-develop tailored enrollment strategies
• Serve as trusted partners to investigators, building strong relationships that improve return on enrollment
• Partner closely with internal Lilly teams to ensure that insights from the field shape development strategies
• Lead site-level strategy and risk planning to ensure predictable enrollment and data delivery

Clinical Research jobs in North Carolina

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Clinical Trial Manager

Clinical Scientist, Medical Monitoring – Oncology – Breast

Senior Business Analytics Advisor – Clinical & Health Outcomes Research

Senior Site Contracts Specialist – Clinical Trial Contracts

Biostatistician

Junior Biostatistician

Clinical Research Comm Specialist III

Grants & Contracts Administrator – Clinical Research Administration Finance Post-Award

Senior Clinical Trial Manager

Clinical Trial Manager

Clinical Scientist – Immunology, Ulcerative Colitis, Crohn’s Disease, Rheumatology

Operations Finance Director – Clinical Research Central Laboratory

Senior Clinical Trial Manager – CNS

Associate Director, Clinical Research Lead – East Coast/Midwest