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Our Staff Roles

Learn more about staff positions and their roles in the UNC Lineberger Clinical Trials Office.

Functional Group Staff

Clinical Operations

The CTO’s clinical operations team has 2 units, one focused on treatment trials where patients receive an investigational drug or an investigational device is used in their care, the FDA and/or Beacon Requiring Unit (FB unit), and one focused on translational sciences and health services protocols (TSHS Unit).

Data Coordinator 1

  • Contribute to study start-up meetings
  • Data entry and query resolution
  • Facilitate and manage external monitoring visits
  • Compile data and safety monitoring committee (DSMC) reports
  • Audit preparation
  • Oncore calendar visit check-in
  • Study document archival

Data Coordinator 2

  • Data coordination (as described above for the Data Coordinator 1 position)
  • Serve as preceptor for new hires
  • Attend site selection visit
  • Participate in process improvement advisory groups

Lead Data Coordinator 

  • 50% data coordination (as described above for Data Coordinator 2 position)
  • Participate in new hire interviews
  • Time management approval of Multidisciplinary DC 1 and 2 positions
  • Serve as a subject matter expert and 1st line resource for staff
  • Contribute to the development of corrective and preventive action plans (CAPA)-including root cause analysis
  • Review monitoring letters (ensuring receipt and checking trends)
  • Review cooperative group data delinquency reports
  • OnCore validation and quality assurance
  • Data and Safety Monitoring Committee (DSMC) report review
  • Develop/edit and lead CTO training courses

Assistant Study Coordinator

  • Introductory role to oncology clinical research coordination
  • Develop foundational knowledge and skills for subject and data management
  • Assist study coordinators in patient prescreening/screening
  • Review subject medical records
  • Organize research related documentation, equipment, and supplies
  • Shadowing and mentorship opportunities

Study Coordinator 1

  • Prescreening/screening of potential patients
  • Conduct informed consent process
  • Eligibility confirmation
  • Schedule and conduct subject study visits
  • Validate Beacon treatment plans
  • Conduct study start-up meetings
  • Data Entry and query resolution
  • Facilitate and manage external monitoring visits
  • Compile data and safety monitoring committee (DSMC) reports
  • Audit preparation
  • Patient reimbursement and Oncore calendar visit check-in

Study Coordinator 2

  • Study coordination (as described above for the Study Coordinator 1 position)
  • Serve as preceptor for new hires
  • Coordinate/attend site selection visit
  • Participate in process improvement advisory groups
  • Eligibility second check

Lead Study Coordinator (Study Coordinator 3)

  • 50% study coordination (as described above for Study Coordinator 2 position)
  • Participate in new hire interviews
  • Time management approval of disease team staff
  • Serve as a subject matter expert and 1st line resource for staff
  • Contribute to the development of corrective and preventive (CAPA)-including root cause analysis
  • Portfolio management (tracking sponsor solicitation for participation, site selection, and reason for declining)
  • Manage clinical trial staff assignments
  • Review monitoring letters (ensuring receipt and checking trends)
  • OnCore validation and quality assurance
  • DSMC report review
  • Develop/edit and lead CPO training courses
  • Audit Epic documentation
  • Ensure/organize holiday coverage

Clinical Trainer

  • Contribute to onboarding process of newly hired clinical staff
  • Collaborate with key clinical stakeholders to identify, develop, and implement new training resources
  • Provide day to day elbow support to ensure training received during onboarding translates into practical skills used by clinical staff to protect our patients, uphold the integrity of our research data, and provide them professional growth

Clinical Lead – Financial Compliance

  • Build Epic billing calendar for all oncology
  • Validate and import OnCore billing calendars and add treatment levels
  • Enters service now ticket for Beacon Build

Spanish Interpreter

  • Provide interpreter services for Spanish-speaking patients on clinical trials
  • Translate study documents

Research Assistants

  • Participant recruitment, screening, eligibility, and registration
  • Conduct study assessments (e.g. questionnaires, biospecimen collection)
  • Organize, collect, and record data in accordance with clinical research protocols and federal regulations (e.g. chart reviews, data from patient surveys, and interviews)
  • Review and verify accuracy of research data collected on-site or remotely by performing source documentation verification and query resolution
  • Report protocol deviations to regulatory authorities
  • Assist with preparation of regulatory documents (e.g. IRB applications, PRIs, and CAPAs)
  • Assist in preparations for monitoring and auditing visits
  • Establish communication systems to ensure complete execution of all aspects of trial conduct; communicate with multiple departments and develop relationships with outside groups and facilities as needed; communicate with study subjects to ensure protocol compliance and maximize outcomes

Data Coordinators

  • Create, modify, and/or manage case report forms for assigned studies
  • Develop tools to gather required data and to facilitate compliant conduct of clinical research; educate team on procedures
  • Organize, collect, and record data in accordance with clinical research protocols and federal regulations (e.g. chart reviews, data from patient surveys and interviews)
  • Report protocol deviations and adverse events according to protocol and institutional guidelines
  • Review and verify accuracy of research data collected on-site or remotely by performing source documentation and query resolution
  • Assist in the preparations for monitoring and auditing visits
  • Collaborate with study, university, and hospital colleagues to facilitate accurate documentation and transfer of required data, ensure data quality, prepare reports and data summaries, and assist in preparation for interim analyses
  • Regularly attend study meetings, report on study progress, and participate in problem-solving strategies

Study Coordinators

  • Recruitment, screening, eligibility, and registration of participants
  • Establish communication systems with various groups such as provider teams, clinic/nursing staff, and other departments involved (TPF, Surg Path, etc.)
  • Develop and maintain tracking and reporting systems for patient recruitment/accrual, specimens, data, etc.
  • Participate in and contribute to study activation and start-up procedures including site initiation visits, start-up meetings, etc.
  • Maintain study kits and other supplies as needed
  • Organize, collect, record, and report/distribute data in accordance with clinical research protocols and federal regulations
  • Perform review and verify accuracy of research data and respond to data queries in a timely manner
  • Develop tools to gather required data as needed, facilitate compliant conduct of clinical research
  • Ensure study compliance to protocol and all established policies and regulations, report deviations and PRIs as appropriate, identify trends and develop CAPAs, as indicated by the IRB and leadership
  • Prepare for and support the execution of routine monitoring and auditing visits
  • Provide back-up support for other studies within the group as needed

Lead Study Coordinators

  • 50% study coordination (as described above for Study Coordinator position)
  • Serve as preceptor for new hires and provide ongoing training and first line support for staff
  • Provide oversight and assist junior staff in daily activities ensuring compliance and adherence to study protocols and deadlines
  • Participate in new hire interviews
  • Attend all relevant research meetings
  • Assist managers with study coverage plans for junior staff
  • Assess workload capacity, inform effort metrics
  • Orchestrate communications/planning between parties (e.g. labs, investigators, outside groups)
  • Contribute to employee evaluations
  • Monitor compliance of junior coordinators including review and approval of timecards
  • Participate in process improvement advisory groups
  • Collaborate with TSHS leadership to develop/edit and lead training courses, as needed

Project Coordinator

  • Assist in the oversight of disease specific portfolio of both interventional and non-interventional studies conducted at UNC-Hillsborough and UNC-Chapel Hill sites
  • Participate in and contribute to study activation and start-up procedures including site initiation visits, start-up meetings, etc.
  • Coordinate methods and techniques amongst investigators, hospital staff, and study staff at UNC-Hillsborough and UNC-Chapel Hill sites to meet study objectives
  • Establish lines of communication between staff and other stakeholders across multiple sites; communicate with multiple departments, develop relationships with outside groups and facilities as needed; communicate with study subjects to ensure protocol compliance and maximize outcomes
  • Recruitment, screening, eligibility, and registration of participants
  • Collaboratively build, modify, and maintain databases to meet study objectives and approved methods of data collection
  • Organize, collect, and record data, verify accuracy and generate reports as needed
  • Perform ongoing evaluation and monitoring of study resources, procedures, and data to track and report study trends to address deficiencies, maintain compliance, and develop strategies to improve study progress
  • Assist with preparation of IRB applications and other regulatory submissions and participate in preparation for routine monitoring and auditing visits
  • Collaborate with corresponding Lead Coordinator to oversee portfolio management
  • Provide back-up support for other studies within the group, as needed
Regulatory Operations

Regulatory Documents Specialist

  • Assists with distribution of essential communications from NCI Central IRB and CTEP
  • Completes prep work to ensure the Regulatory Associates have the timelines and materials to complete IRB renewals and FDA annual reports

Regulatory Assistant

  • Maintenance of study documents and staff training
  • Process Institutional Review Board (IRB) in OnCore
  • Facilitate monitoring visits (regulatory review)
  • Review and quality check of files for audits

Regulatory Associate I

  • Initial IRB submission and approval processing
  • Corrective and preventive action (CAPA) plan creation
  • IRB maintenance submission (amendments, renewals, new safety information)
  • Protocol Review Committee (PRC) maintenance submissions (amendments, renewals)
  • Lead discussions with investigators about regulatory progress
  • Meet with study monitors
  • Regulatory compliance guidance
  • Lead new study activation for regulatory
  • Protocol Review Committee (PRC) initial and renewal submissions
  • Investigational Drug Services (IDS) initial submissions
  • Institutional Biosafety Committee (IBC) initial submissions
  • Radiation Safety Committee (RSC) initial submissions

Regulatory Associate II

  • Regulatory responsibilities as described above for the Regulatory Associate I position
  • Develop, write, and provide input on standard operating procedures, work instructions, and internal processes.
  • Mentor new Regulatory team members
  • Assist Regulatory Associates in the I role with the development of CAPAs and root causes analyses for non-compliance events
  • Participate on CPO committees/task forces/working groups
  • Assist in training Regulatory team members as needed

Lead Regulatory Associate

  • 55% Regulatory responsibilities as described above for the Regulatory Associate II position
  • Review Promptly Reportable IRB submissions
  • Take lead role in activation by preparing initial submissions as well as monitoring and assisting with activation activities performed by other Regulatory team members
  • Review and follow up on monitoring letters and audit reports
  • Monitor trends in action items/finding from monitoring letter and audit reports
  • Participate in interviews of Regulatory applicants
  • Run and review weekly IRB lapse reports and follow up with Regulatory staff to address any delays in submission of continuing review applications to the IRB
  • Sign off on timecards for Regulatory Associate and Assistants in the I and II roles
  • Assist in assessing workload capacity, informs office metrics
  • Assist in administrative maintenance of eRegulatory system

Regulatory Associate & Assistant Trainers

  • Development of a regulatory training program
  • Oversight of the regulatory training program
  • Run program-wide training and onboarding
  • Provide hands‐on support, direction and coaching to both new and existing regulatory staff members
Sponsor Operations

Multicenter Project Manager

  • Works to identify multicenter sites to conduct investigator-initiated trials
  • Confirms eligibility of subjects at multicenter sites
  • Manage multicenter sites to ensure patient safety and study compliance
  • Lead monthly study team calls
  • Lead site initiation meetings (SIMs)
  • Answer questions from multicenter site study teams

Senior Multicenter Project Manager

  • Responsible for project planning and activation across study sites within the United States. Able to identify bottlenecks in the activation process and provide solutions
  • Responsible for project execution, monitoring, and surveillance of risk
  • Responsible for financial management (submission of confidential disclosure agreement (CDA), subcontracts, data use agreement (DUA), material transfer agreement (MTA), cooperative research and development agreement (CRADA), and others as applicable) and project status reporting
  • Responsible for project close out
  • Responsible for training new staff members, and education of site staff/investigators regarding specific study compliance throughout the execution of the studies through close out
  • Prepare relevant standard operating procedures (SOP) and/or work instructions (WI)

In-House Monitor

  • Monitor trials according to the institutional data monitoring plan
  • Ensure reported data are accurate, complete, and verifiable from source documents
  • Ensure the trial is conducted in compliance with the currently approved protocol, other applicable regulatory requirements, and site standard operating procedures (SOPs)

Senior In-House Monitor

  • Supports study activation activities (site initiation meeting (SIM), protocol/lab manual reviews, electronic case report form (eCRF) testing) and lead monitoring discussion during SIM
  • Provides input on new procedures related to data entry/management. Collaborates with clinical data management associate and multicenter project manager to ensure data integrity
  • Responsible for training of staff and investigators across study sites on study/data to ensure compliance throughout the execution of study through close-out
  • Responsible to carry out single IIT study close out
  • Assists in training and orienting new team members
  • Monitor the trials (IITs and cooperative group studies) according to the institutional data monitoring plan, and ensure compliance with protocol, standard operating procedures (SOPs), institutional requirements, GCP and FDA guidelines

National and Cooperative Group Project Manager

  • Serves as the liaison between UNC and the National Cancer Institute (NCI) and national cooperative groups
  • Facilitates cooperative group audits for UNC and affiliate. Manages timelines and coordination of audits as well as submission of audit responses and corrective action plans.
  • Oversee and maintain UNC compliance with national group rosters, memberships, subject registration, data entry, and query response.

PRC Coordinator

  • Accepts and processes PRC applications as well as processes and disseminates approvals
  • Subject matter expert in PRC submissions
  • Coordinators the PRC meeting, writes minutes, drafts approval letters
  • Trains staff in completion of PRC submissions

DSMC Coordinator

  • Accepts and processes DSMC submissions as well as processes and disseminates approvals
  • Subject matter expert in DSMC submissions
  • Coordinators the DSMC meeting, writes minutes, drafts approval letters
  • Trains staff in completion of DSMC submissions
Clinical Trial Activation

Clinical Trial Activation Project Manager

  • Project management of clinical trial activation
    • Schedule activities/completion dates
    • Monitor progress using PERT charts including allowed slack times, critical path deliverables, key milestone deadlines
  • Lead, coach, motivate, and influence assigned study team members to ensure timely completion of high-quality deliverables and staff accountability for assigned tasks
  • Track trends and analyze data regarding pitfalls to activation and proposing initiatives to address hurdles

Pre-Award OnCore Financial Analyst

  • Works with OnCore India on study calendar builds
  • Coordinates financials and coverage analysis
  • Build items within calendar- procedures, prices, identify pass-through items
  • Ensure protocol amendment updates

Financial Analyst

  • Negotiate budgets
  • Work with the Office of Clinical Trials on Billing Coverage Analysis coordination
  • Process budget amendments

Senior Financial Analyst

  • Review and negotiate complex clinical trial budgets and payment term arrangements with external sponsors
  • Assist with training of new employees and providing ongoing guidance
  • Develop budgets for Investigator Initiated Clinical Trials (IITs)
Clinical Development

Protocol Development Associate

  • Clinical protocol concept development
  • Letters of Intent (LOIs)/Budget Templates
  • Clinical Protocol Development
  • Administrative Letter writing
  • Consent Form template development
  • LCCC Sponsor SOP development
  • Clinical investigator training

Senior Protocol Development Associate

  • Clinical protocol development (as described above for the Protocol Development Associate)
  • Consultation on strategic protocol design
  • Project management of the investigator initial trail portfolio
  • Continued strategic support of the evolving clinical protocol design

IND (Investigational New Drug) Specialist

  • IND applications development
  • Model consent forms writing
  • IND project management
  • Patient Education Materials
  • Protocol amendments writing
  • LCCC sponsor compliance
  • LCCC sponsor SOP development
  • Clinical investigator training

Clinical Development Associate

  • IND applications development
  • Model consent forms writing
  • Patient Education Materials
  • Clinical protocol concept development
  • Letters of Intent (LOIs)/Budget Templates
  • Clinical Protocol Development
  • Administrative Letter writing
  • Consent Form template development
  • LCCC Sponsor SOP development
  • Clinical investigator training
Workforce Development & Administration

Training Program Manager

  • Development and implementation of the office-wide training program
  • Monitoring and coordination of ongoing training that is needed
  • Serving as a lead for subject matter expert trainers
  • Program manager for internships and investigator training programs

Administrative Assistant

  • Communication hub- shared all office calendar, main phone line, and receipt of incoming faxes
  • Equipment and IT support
  • Supply and inventory management
  • Mail and package intake
  • Administrative support including interview scheduling and management
  • Compliance support- PRC, DSMC, RAFT, Training, and INDs
  • General staff onboarding

Research Assistant

  • Oversight and distribution of kits and shippers
  • Supports maintenance of patient binders and regulatory files
  • Supports archiving of study material to offsite storage
Clinical Data & System Operations

Clinical Data Management Associate

  • Identifies critical data for collection during trial activation
  • Data quality assurance
  • Support for abstracts, manuscripts, and results reporting for data safety monitoring committee (DSMC), IND submission, and clinicaltrials.gov

eCRF (electronic Case Report Forms) Developer

  • Develops electronic case report forms using FDA-supported data standards
  • Builds research calendars in the EDC system
  • Maintains data standards library

SDTM (Study Data Tabulation Model) Programmer

  • Develops the submission data standard deliverables for regulatory application submissions
  • Programs study specific analysis datasets, reports, and listings to support the monitoring and analysis of clinical trials
    • Generate Study Data Tabulation Model (SDTM) domains, advanced data management (ADaM) datasets, and Define.xml files and specifications.

Clinical Trials Analyst

  • Provides comprehensive registration and results reporting to ClinicalTrials.gov to Cancer Center Members
  • Administers registration and accrual reporting to the NCI’s Clinical Trials Reporting Program (CTRP)
  • Produces DataTable4 reports for the UNC Lineberger Cancer Center Support Grant

OnCore and Advarra EDC (Electronic Data Capture) Administrator

  • OnCore and Advarra EDC Administration: work collaboratively within and across groups to administer, problem-solve, and develop these application. Participate in upgrade, testing, and validation activities per SOPs. Conduct analyses, testing and implementation of new functionality, upgrades, patch or change functionality and integration with other systems
  • OnCore Optimization: remediate and optimize the use of OnCore throughout Lineberger. Work with functional group leaders and staff to assist with process improvement, make workflow adjustments, and ensure utilization of OnCore supports clinical research operations and reporting.
  • Application programming interface (API) Projects: Oversee security processes for internal or external entities to access OnCore data using APIs. Develop API to improve workflow functionality with ClinicalTrials.gov and clinical trials reporting program (CTRP).

Florence Administrator

  • Florence Administration: manage users and role building; ensure compliance with institutional and 21CFR Part 11 requirements and maintain validation documentation
  • Florence Technical Support: provide access and training; troubleshoot issues; communicate with users to assess scope of problems, work quickly to resolve issues quickly and ensure end-user satisfaction; conduct monthly accuracy reviews.
  • Provide backup support for OnCore and Advarra Electronic Data Capture (EDC)

OnCore Analyst

  • Develop and publish OnCore and Advarra Electronic Data Capture (EDC) reports per request, programming per specifications and automating for on demand access from OnCore; work with stakeholders to ensure requested projects are responsive to reporting needs
  • Develop and disseminate minimum footprint and other actionable reports related to OnCore data quality
  • Provide monthly, quarterly, and annual exports for reporting to the LCCC Data Safety & Monitoring Committee and to the FDA

Data Analyst & Report Writer

  • Develops reports and dashboards that enable leadership to define strategies, monitor trends and operations, and aid oncology clinical research reporting, operational process improvement, and strategic initiatives
  • Improve meaningful data accessibility by combining data from multiple sources to generate reports and visualizations that are directly interpretable
  • Develop and maintain a self-service and on-request infrastructure for various Lineberger stakeholders to gain access to data needed to drive decision-making

Technical Support Specialist

  • Frontline support for 350+ users of OnCore and Advarra EDC, including troubleshooting and resolution of technical problems. Communicate with users to assess scope of problems, work quickly to resolve issues quickly and ensure end-user satisfaction
  • Manage user access and training; draft or revise user training manuals and procedures and provide training.
  • Support maintenance of data quality for reporting to the NCI; run discrepancy reports to identify missing or erroneous data; communicate and retrain as needed. Support data entry into Clinical Trials Reporting Program (CTRP)

Interested in joining our team? Learn more about open positions

Join the Team