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Clinical Research Coordinator I
4 months ago
Classification Title:
Clinical Research Coordinator I - Cardiovascular Surgery
Job Description:
Clinical Research Coordinator I coordinates ongoing clinical research trials within the Division of Cardiovascular Surgery under the direction of the senior study coordinator. As part of an interdisciplinary health team, the incumbent will collaborate with other Clinical Research Coordinators, physicians, nurses, and other key personnel in the department and clinic to ensure compliance with protocol requirements and satisfactory care for enrolled patients. The incumbent will also assist in the development of protocol methodologies and data collection
Coordination of Protocol Subjects & Data Collection
* Performs subject screening and consent for clinical protocols under the direction of the Principal Investigator.
* Serves as patient resource and educator for information regarding the study or clinical symptoms.
* Prepares and ships central laboratory samples as per protocol requirements.
* Collects baseline and follow-up data from the medical record.
* Documents findings in appropriate source records and case report forms.
* Schedules and attends clinic appointments for patients as required by the protocol.
* Communicates with nursing staff and OR Staff about patient care according to protocols.
* Assists with operating room protocol requirements where appropriate.
* Records patient symptoms and adverse events in conjunction with care providers.
* Reports and follows up adverse events and serious adverse events, after discussion with the Principal Investigator, to sponsor an Investigational Review Board as required by protocol
Coordination of Protocol Compliance
* Maintains knowledge base of Good Clinical Practice Guidelines and Federal Code of Regulations regarding clinical trial conduct.
* Coordinates and maintains HIPAA compliance for assigned studies.
* Communicates with interdisciplinary health team in care of patients involved in research studies to ensure regulatory compliance.
* Interacts with local laboratories and diagnostic study centers to ensure clinical protocol requirements are complete for studies.
* Coordinates efforts of Investigational Pharmacist and maintains site records for Good Clinical Practice and sponsor guidelines.
Research Support
* Designs Case Report Forms and Source Documents for clinical protocols where required.
* Communicates with trial monitors to facilitate data monitoring and query resolution.
* Submits protocols to the CRH and IRB offices to ensure compliance under the direction of the senior study coordinator.
* Organizes and maintains regulatory files for clinical studies performed within the Division.
* Interacts with institutional Investigational Review Board under the direction of Principal Investigator for clinical research protocols.
Tracks the type of study services performed to ensure that they are compensated appropriately.
* Tracks all patient billable services.
* Performs billing review for study subjects.
* Dispense human subjects' payments to study participants.
Other duties as assigned. Maintains working knowledge of computing skills: Microsoft Word for Windows, PowerPoint, Access, and Excel. Facilitates efforts for ongoing database(s) within the Division.
