Classification Title:
Clinical Research Coordinator I - Vascular Surgery
Classification Minimum Requirements:
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.
Job Description:
Clinical Research Coordinator I coordinates ongoing clinical research trials within the Division of Vascular 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.
Duties Include:
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 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
- 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. Maintains awareness of Good Laboratory Practices as
Expected Salary:
$46,000 - $50,000
Required Qualifications:
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.
Preferred:
Special Instructions to Applicants:
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.
Health Assessment Required:
Yes
