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Clinical research coordinator responsibilities

Clinical Research Coordinator responsibilities & activities

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Clinical research coordinator responsibilities

  1. 1. Clinical Activity/Coordination Drug Accountability Reconcilation of drugs used for protocol treatment, including communication with pharmacy or drug supply. Patient Care Clinical research management of patients. This includes time in clinic & with physicians, chart reviews, protocol reviews, travel time to/from pharmacy, CRC, preparation for an appointment, & general patient management that is not related to general screening activities. Includes tumor measurements.
  2. 2.  Patient Consent or Re-Consent Review of consent with patient and documentation of consent process.  Patient Education Discussion of study processes & procedures with patients. “Not” including consenting.  Scheduling Patient scheduling for all clinical procedures/visits, including review of future visits & procedures  Source documentation completion Examples: putting a note in EPIC, lab signoffs, CT scan measurements
  3. 3. Data Management  Query Resolution, completion of corrective actions, & NTF Review and completion of data queries & followup on corrective actions. Notes to file.  Research Chart Mgmt Assembly & organization of research and clinic chart. Includes boxing up charts for close out.  CRF Completion Completion of all electronic or paper CRFs.  OnCore - Subject Entry of patient accrual, off treatment, off study, etc.
  4. 4. SAESAE All data collection, source document completion specific for the SAE event, and SAE form completion, including PI review & signature.
  5. 5. Screening and Enrollment Logs Review and completion of enrollment and screening logs. Source document development Develop documents to manage patient, including changes due to amendments. Subject Registration Registering subject through IVRS or sponsor. Also includes documentation to DSMC.
  6. 6. Protocol Training/Meetings eCRF Training On-line training GCP Training On-line training Internal Training & Meetings Reviewing internal procedures & processes for protocol startup. Include ongoing meetings to discuss trial activity Investigator or Cooperative Group meetings Time spent on investigator or cooperative group meetings including travel.
  7. 7. Protocol Training/Meetings Protocol Review Review of protocol for research related procedures & logistics, including budgeting. Site initiation/Start up visit/Retraining Preparation and time spent on start-up meeting. Site selection visit Completion of paperwork for site selection. Scheduling of site visit and time spent with sponsor/CRO during a site selection visit. Training – Other On-line training beyond eCRF or GCP training

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