Our Staff Roles

Data Coordinator

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

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
• 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 1^st 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

Clinical Trainer

• 50% study coordination (as described in Study Coordinator 2 position)
• 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

Spanish Interpreter

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

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

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 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 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)

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

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’s 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