Clinical Research Coord I - Dept. of Surgery

Clinical Research Coordinator I

Associates 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 consent for clinical protocols under direction of 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 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 Principal
  Investigator to sponsor and Investigational Review Board as required by protocol

Coordination of Protocol Compliance

• Maintains knowledge base of Good Clinical Practice Guidelines and Federal Code of Regulation 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

• Assists medical and scientific partners to design protocol methodologies for basic science preclinical studies and clinical protocols.
• Helps with protocol development and protocol endpoints to ensure statistical and clinical relevance of studies.
• Assesses clinical needs by performing literature review and discussion with faculty advisors within Division.
• Prepares and submits filings of protocols to Investigational Review Board and Animal Care Committees as needed.
• Designs Case Report Forms and Source Documents for clinical protocols where required.
• Assists with grant development projects as needed for preclinical studies within Division.
• Assists with manuscript preparation and abstract submission for principal investigators.
• Submits protocols to the RAC and IRB offices to assure compliance under the direction of the senior study coordinator.
• Organizes and maintains regulatory files for clinical studies performed within Division.
• Interacts with institutional Investigational Review Board under direction of Principal Investigator for clinical research protocols.

Tracks the type of study services performed to ensure that they are compensated appropriately

• Performs billing review for study subjects
• Dispense human subjects payment 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

$43000 - $52000

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.