Clinical Research Coordinator I

Associate’s degree or an allied health professional degree in an appropriate area and one year of relevant experience; or an equivalent combination of education and experience

Coordination of Protocol Subjects & Data Collection

• Performs subject screening and obtains consent for clinical protocols under the direction of the principal investigator.
• Serves as a patient resource and educator regarding study information and clinical symptoms.
• Prepares and ships central laboratory samples in accordance with 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 protocol.
• Communicates with nursing staff and OR staff regarding patient care in accordance with protocols.
• Assists with operating room protocol requirements, as appropriate.
• Records patient symptoms and adverse events in conjunction with care providers.
• Reports and follows up on adverse events and serious adverse events, in consultation with the principal investigator, to the sponsor and Institutional Review Board, as required by protocol.

Coordination of Protocol Compliance

• Maintains knowledge of Good Clinical Practice guidelines and the Federal Code of Regulations regarding clinical trial conduct.
• Coordinates and maintains HIPAA compliance for assigned studies.
• Communicates with the interdisciplinary healthcare team involved in the care of patients participating in research studies to ensure regulatory compliance.
• Interacts with local laboratories and diagnostic study centers to ensure clinical protocol requirements are met for studies.
• Coordinates efforts with the investigational pharmacist and maintains site records in accordance with Good Clinical Practice and sponsor guidelines.

Research Support

• Designs case report forms and source documents for clinical protocols, as 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 the Institutional Review Board under the direction of the principal investigator for clinical research protocols.
• Tracks the types of study services performed to ensure they are compensated appropriately.
• Tracks all patient billable services.
• Performs billing reviews for study subjects.
• Dispenses human subject payments to study participants.

Maintains working knowledge of computing skills: Microsoft Word for Windows, PowerPoint, Access, and Excel.

Facilitates efforts for ongoing database(s) within the Division.

Other duties as assigned.

$50,000 - $56,000 annually

Associate’s degree or an allied health professional degree in an appropriate area and one year of relevant experience; or an equivalent combination of education and experience

In order to be considered, you must upload your cover letter and resume.

Application must be submitted by 11:55 p.m. (ET) of the posting end date.