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

Functional Group Staff

Clinical Operations

Data Coordinator

  • Data entry and query resolution
  • Facilitate and manage external monitoring visits
  • Audit preparation

Study Coordinator 1

  • Prescreening/screening of potential patients
  • Conduct informed consent
  • Eligibility confirmation
  • Schedule and conduct subject study visits
  • 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

Study Coordinator 2

  • Study coordination (as described above for the Study Coordinator 1 position)
  • Serve as preceptor for new hires
  • Review clinical trial unit (CTU) flowsheet templates for accuracy
  • Complete feasibility questionnaires
  • 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 SC 1 and 2 positions
  • 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
  • Participate in biannual meetings with disease group leaders (POD)
  • Portfolio management (tracking sponsor solicitation for participation, site selection and reason for declining)
  • Managing clinical trial activation timelines
  • Review monitoring letters (ensuring receipt and checking trends)
  • OnCore validation and quality assurance
  • Data tracer validation and quality assurance
  • DSMC report review
  • Develop/edit and lead CPO training courses
  • Auditing of Epic documentation
  • Ensure/organize holiday coverage
  • 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
Regulatory Affairs

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

  • 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)
  • FDA annual reports
  • Leading discussions with investigators about regulatory progress
  • Meeting with study monitors
  • Regulatory compliance guidance
  • Leading new study activation for regulatory
  • Resource and feasibility team (RAFT) committee submissions
  • Protocol Review Committee (PRC) initial submissions
  • Investigational Drug Services (IDS) initial submissions
  • Institutional Biosafety Committee (IBC) initial submissions
  • Radiation Safety Committee (RDC) initial submissions
Compliance

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

Training Coordinator

  • Development and implementation of the training curriculum
  • Monitoring and coordination of ongoing training that is needed
  • Serves as a training expert and liaison to the various CPO functional groups in the development of role-specific training
Pre-Award Finance

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
Multicenter 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

In-House Monitor

  • Monitor the trial 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)
Office Management

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
Other Clinical Trial Positions at UNC Lineberger

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 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 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

Clinical Data Management Associate

  • eCRF development and maintenance
  • Data quality assurance
  • Support for abstracts, manuscripts, and results reporting for data safety monitoring committee (DSMC), IND submission, and clinicaltrials.gov

Clinical Trials Analyst

  • Provide comprehensive oversight and implementation of ClinicalTrials.gov
  • Complete clinicaltrials.gov registration and reporting
  • Provide comprehensive oversight and implementation of the National Cancer Institute‚Äôs Clinical Trials Reporting Program (CTRP)

Accountant

  • Operational budgeting
  • Billing
  • Study revenue and expense tracking and invoicing
  • Study team financial reporting and tracking
  • Vendor and site payments, hospital and physician payments
  • Patient reimbursements and stipends

Interested in joining our team? Learn more about open positions

Join the Team