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Clinical Research Coordinator
2 months ago
The Clinical Research Coordinator reflects the mission, vision, and values of Northwestern Memorial Healthcare, adheres to the organization's Code of Ethics and Corporate Compliance Program, and complies with all relevant policies, procedures, guidelines, and all other regulatory and accreditation standards.
Key Responsibilities- Study Protocol Coordination: Facilitates, maintains, and coordinates the logistical aspects of assigned study protocols with other research staff in accordance with Good Clinical Practice, standard operating procedures, and sponsor requirements.
- Patient Care: Provides direct patient care pursuant to a study protocol, including dispensation of investigational medications and performance of study tests under the delegation and direction of the principal investigator or supervising physician.
- Study Visits and Meetings: Attends investigator's meetings, coordinates and attends pre-study site visits, study initiation visits, and all other study-related visits by Monitors or Sponsor representatives, when required.
- Vendor Management: Arranges for procedures and necessary visits performed by external vendors that are necessary to the conduct of the study.
- Protocol Meetings and Scheduling: Schedules and leads in-house protocol meetings to review study-related procedures, staffing, and visit flow.
- Medical Needs and Coverage: Schedules and coordinates all medical needs and coverage for protocol-related procedures.
- Communication and Documentation: Maintains and documents all study-related communication, including, but not limited to, the principal investigator or supervising physician, study subjects, Sponsor or Sponsor representative(s), and IRB throughout the clinical trial.
- Subject Instructions and Support: Responsible for giving subject instructions for study participation and serves as the primary contact for subjects by being available to handle study-specific questions, concerns, or events.
- Protocol Procedures: Ensures all protocol procedures are completed per study requirements.
- Adverse Event Reporting: Obtains and documents all adverse event data on appropriate forms and reports adverse event data to the appropriate parties as outlined by the study protocol, regulations, and applicable policies and procedures.
- Source Document Verification: Assures quality and completeness of source documents collected during the course of the study to assist with overall principal investigator review and approval.
- Data Entry and Verification: Ensures accurate, complete, and timely data entry into CRFs using 100% source documentation verification to assist with overall principal investigator review and approval.
- Study Visits and Site Management: Schedules, leads, and assists with all study-related visits on site and is readily available during visits for applicable corrections, questions, or other study-related or site needs.
- Document Retention and Security: Supervises document retention, security, and destruction, where applicable.
- Training and Development: Responsible for completing all necessary training for the position, including study protocol-specific training and Health System policies and procedures.
- Staff Training and Support: Trains other study-specific research staff in collection and reporting of required data, where applicable.
- Research Files and Reporting: Maintains research files, designs forms as needed, reports findings as appropriate, assists in preparation or review of material for submission to an IRB, including reviewing and editing protocols and consent documents, where applicable.
- Additional Responsibilities: Performs all other functions as related to this job and assigned.
- Travel Requirements: Ability to travel between hospital locations where research is conducted.
