Research Analyst

• Lead computerized system validation (CSV) activities for regulated digital and AI applications throughout the SDLC
• Develop and execute validation deliverables including Validation Plans, Risk Assessments, IQ/OQ/PQ documentation (where applicable), test scripts, traceability matrices, and Validation Summary Reports
• Partner with Business Analysts, Quality Assurance, IT, vendors, and project teams to ensure systems meet business and regulatory requirements
• Review software requirements, functional specifications, design documentation, and change controls to ensure validation readiness
• Design, execute, and document risk-based testing strategies that demonstrate systems perform as intended
• Create and maintain validation evidence in accordance with internal procedures and regulatory expectations
• Support system implementations, upgrades, patches, and application enhancements
• Review and approve validation-related change controls and ensure ongoing compliance for validated systems
• Investigate test failures, identify root causes, and collaborate with technical teams to resolve issues
• Participate in internal audits, sponsor audits, and regulatory inspections by providing validation documentation and subject matter expertise
• Contribute to continuous improvement initiatives that enhance validation processes, testing efficiency, and compliance

Senior Validation Analyst, Clinical Research

• Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging advanced capabilities to drive industry leading performance.
• Partners with study teams, AbbVie internal R&D stakeholders, investigators, and site staff for meaningful and effective engagements positioning AbbVie as the partner of choice in clinical trials.
• Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.
• Conducts site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.
• Responsible for activities as assigned by manager.
• Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.
• Generates and ensures effective recruitment and retention techniques/plans based on the patient disease journey.
• Demonstrates ability to openly listen to and consider viewpoints to enhance outcomes.
• Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
• Manages investigator payments as per executed contract obligations, as applicable.

Senior Clinical Research Associate

• Responsible for managing the research activities at sites participating in Worldwide’s clinical research projects
• Conduct study initiation visits (SIVs)
• Ensure compliance with obtaining informed consent
• Reporting potential safety-related events

Senior Clinical Research Associate – Rare Disease

• The Senior Research Analyst responds to complex legal, corporate, and industry research requests, meeting the daily information needs of firm lawyers, business professionals and clients using industry-standard databases and tools
• This role conducts research at an advanced level, evaluates sources, organizes findings into high-quality work product, manages workflow priorities and deadlines with sound judgment and accountability, and takes a proactive role in promoting Research Services tools, offerings, and services throughout the firm
• Lead research strategy for all sophisticated queries
• Exercise judgment and accountability in prioritizing billable workflow and either meeting or communicating effectively around deadlines
• Develop and maintain a keen understanding of the information needs, workflow, and preferences of users and stakeholders in order to support and improve ease of access to information

Senior Research Analyst

• Oversee and manage clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards
• Lead on clinical trial monitoring tasks requiring technical depth, focusing on quality and continuous improvement
• Monitor clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards
• Conduct site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution
• Collaborate with cross-functional teams to ensure timely and accurate data collection and reporting
• Provide training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct
• Build and maintain effective relationships with site personnel and stakeholders to facilitate smooth trial operations

• Develop clinical trial budgets, including review of protocols and relevant documents to ensure that appropriate costs and allocation of institutional resources are fully captured in the budget.
• Work in collaboration with ancillary teams, departments, investigators, research staff, supporting administration, and sponsors/funding agencies to create complete, comprehensive, accurate and timely budgets.
• Ensure appropriate research rates are applied to study budgets.
• Independently develop, negotiate, and finalize budgets of moderate complexity with sponsors, academic sites, and other extramural funding sources to reach an agreement on budget and payment terms.
• Submit and maintain the budget and other financial information into OnCore Clinical Trial Management System (CTMS) to maintain proper reimbursement and revenue integrity.
• Perform pre-award quality assurance to verify completion of required elements prior to Medicare Coverage Analysis.
• Communicate and meet with stakeholders to facilitate ongoing budget discussions and provide updates to relevant parties.
• Use advancing knowledge to develop and disseminate clinical research education as needed in accordance with federal regulations, institutional policies, and specific protocol requirements.
• Apply knowledge of clinical research to provide recommendations and direction to clinical research teams to ensure budgetary compliance throughout all phases of the Clinical Trial Financials Lifecycle.
• Develop and support the formulation of program policies, procedures, and resources to establish and enhance clinical trial financials workflows.
• Provide excellent customer service while maintaining accurate results in a fast-paced, deadline-driven team environment.
• Engage in special projects and ad hoc duties as a member of the administrative team.

Clinical Trials Budget Specialist II

• Translates business requirements into business solutions;
• Acts as liaison between departmental leaders, staff and information technology staff to design and configure business solutions to ensure business requirements have been met.
• Works closely with stakeholders to define business requirements and with technical staff to develop solution alternatives and actively participates in defining objectives to support changing business needs and availability.
• Coordinates IT troubleshooting and day to day activities within the department to ensure seamless and minimal downtime of hardware, software and reporting requirements.
• May manage small to mid-sized projects/tasks and represent the department on larger enterprise-wide project teams.
• Creates and maintains project schedules by developing project plans and specifications, estimating time requirements, establishing deadlines, monitoring milestone completion, tracking all phases of the project product/service lifecycle, providing timely reporting of issues that impact project progress, coordinating actions, and resolving conflicts.
• Coordinates and conducts project team meetings regularly to review project deliverables and deadlines.
• Has knowledge and experience in the various techniques to elicit, analyze and communicate requirements within assigned functional areas.
• Establishes test plans, test cases and executes testing.
• Assists with end user training.
• Recommends information technology solutions to meet business needs and coordinates the planning, development, and implementation of these solutions.

Business Analyst II

• Provide technical and scientific expertise in the research and development of plasma derived or recombinant proteins
• Assists in development of actions plans in support of departmental goals
• Provides technical reports to immediate supervisor and within group meetings
• Executes experiments independently
• Maintains laboratory facilities

Associate Research Scientist II / Senior Associate Research Scientist I

• Conduct phone surveys with clients, family members, and caregivers
• Accurately document feedback
• Create positive experiences for survey participants
• Help organizations improve care and employee satisfaction

Satisfaction Research Center Associate

• Assist with quantitative and qualitative research activities to support projects.
• Analyze large health-related datasets.
• Assist in developing and implementing processes to assure quality and accuracy of data analyses.
• Review and proof own work for accuracy and completeness.
• Assist with project management responsibilities including scheduling, preparing meeting agendas, and recording meeting minutes.
• Contribute to and/or prepare portions of technical memoranda, reports, and presentations.

Research Analyst, Medicaid Policy

• Maintains designated applications in research department databases
• Creates new databases, prepares and runs data analysis queries, and uploads local database to the national database center
• Uses existing database to create reports as requested
• Performs data manipulation and migration
• Reviews data quality reports for data submissions and errors
• Ensures data requests are received, have authorizations, are evaluated, and reported
• Prepares specifications and summary reports for data queries and requests
• Performs chart abstraction
• Provides administrative support when needed

Senior Research Associate, GCM

• Collaborate with team members to ensure all project deadlines are met and project logistics are accounted for
• Assist in all aspects of research across operational phases throughout the project, including survey proofing, data cleaning, data charting, data checking, recruitment updates, etc.
• Document client calls and internal meetings, including providing feedback to the relevant projects and ensuring documentation is shared with team for collaboration
• Support client deliverables by creating slides, identifying case studies, syndicated data and desk research that lend to the overall insights and narrative
• Manage logistical issues around fielding, data processing, vendors, etc., including identifying process improvements
• Proactively communicate availability/capacity/contributions to the team

Research Analyst – Custom Market Research

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance
• Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate
• Demonstrates diligence in protecting the confidentiality of each subject/patient
• Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues
• Assesses site processes as per the Clinical Monitoring/Site Management Plan (CMP/SMP)
• Conducts Source Document Review of appropriate site source documents and medical records
• Verifies required clinical data entered in the case report form (CRF) is accurate and complete
• Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
• Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
• Verifies site compliance with electronic data capture requirements
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security
• Verifies the IP has been dispensed and administered to subjects/patients according to the protocol
• Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan
• Supports subject/patient recruitment, retention and awareness strategies
• For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met

Clinical Research Associate – Full-Service

• The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD)
• The CRA acts as the main contact with the study site
• Responsible for monitoring the study conduct
• Responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies
• Ensures compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations

Senior Clinical Research Associate – All US Locations

• The CRA works in close collaboration with other CRAs and the Local Study Team to ensure that study commitments are achieved in a timely and efficient manner
• Acts as the main contact with the study site and has the responsibility for monitoring study conduct
• Responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies
• Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training
• Ensures that all study documents under their responsibility are available and ready for final archiving
• Collaborates with local Medical Science Liaisons as directed by LSAD or line manager

Senior Clinical Research Associate, All US Locations - FSP

• Assist with quantitative and qualitative research activities to support projects
• Analyze large health-related datasets
• Assist in developing and implementing processes to assure quality and accuracy of data analyses
• Review and proof own work for accuracy and completeness
• Assist with project management responsibilities including scheduling, preparing meeting agendas, and recording meeting minutes
• Contribute to and/or prepare portions of technical memoranda, reports, and presentations

Research Analyst – Medicaid Policy Research

• Conducting thorough research into an individuals’ background using a variety of tools, such as databases and public records
• Gathering information, analyzing data, and compiling this information to be entered into a final report
• Processing searches related to background screening reports
• Ensuring all searches are processed and reported according to state and federal laws as outlined in AccuSourceHR’s reporting guidelines
• Ensuring all searches are processed according to client guidelines
• Retrieving public records information and entering said information into our platform
• Analyzing information and comparing data sets to confirm matching identifiers
• Performing other duties as assigned
• Meeting or exceeding minimum standard service requirements

Research Analyst jobs in North Carolina

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Senior Validation Analyst, Clinical Research

Senior Clinical Research Associate

Senior Clinical Research Associate – Rare Disease

Senior Research Analyst

Senior Clinical Research Associate

Clinical Trials Budget Specialist II

Business Analyst II

Associate Research Scientist II / Senior Associate Research Scientist I

Satisfaction Research Center Associate

Research Analyst, Medicaid Policy

Senior Research Associate, GCM

Research Analyst – Custom Market Research

Clinical Research Associate – Full-Service

Senior Clinical Research Associate – All US Locations

Senior Clinical Research Associate, All US Locations - FSP

Research Analyst – Medicaid Policy Research

Research Specialist