Clinical Research Coordinator II Job at Fresenius Kidney Care Eupora (Las Vegas)

Job Description

This role requires 100% travel. PURPOSE AND SCOPE: Works under the supervision of the Principal Investigator (PI), Director and other site personnel as applicable. Conceptually applies the research protocol to the clinical setting to allow accurate and timely completion of all duties. Maintains appropriate documentation associated with the assigned clinical study. Ensures studies are conducted according to established company policies and procedures as well as all applicable State and Federal regulations, specifically Good Clinical Practice (GCP), ICH, and FDA guidelines.

Job Responsibility

Develops in-depth understanding of each study protocol to ensure all aspects of the protocol are adhered to in accordance with FDA, GCP, and ICH Guidelines
Under the supervision of the Principal Investigator (PI) and appropriate management prepares and submits regulatory documents in an accurate and timely manner
In collaboration with the PI, incorporates clinical judgment and knowledge of protocol to identify potential study participants according to inclusion and exclusion criteria
Obtains informed consent according to GCP
Schedules subject visits
Prepares labs/tests per protocol
Responsible for study drug storage and drug accountability according to the parameters of the study protocol and sponsor requirements
Administers the investigational product according to the parameters of the study protocol and under the direction of the physician
Monitors and evaluates patients' condition with regard to the investigational product
Consults with PI regarding the appropriate administration of investigational product
Conducts routine assessments to evaluate the subject's response to investigational product, and communicates observations to the PI, sponsor and IRB as appropriate
Educates the subject about the applicable study particulars
Informs/updates the subject about pertinent study details as needed
Documents subject information as it pertains to the clinical study according to the principals of ALCOA
Meets with the study monitor to review, verify and correct all data entered onto the case report form and to ensure appropriate maintenance of study records
Reviews all lab/tests with the physician in a timely manner
Reports subject's progress, complaints and issues to PI, study sponsor, or IRB as needed in a timely manner
Conducts ongoing assessments of the overall study execution within the facility/practice, communicating concerns to the Director, PI, study sponsor or IRB as needed
Notifies appropriate management and external parties of serious adverse events according to protocol
Collects pre-study essential documents to protocol as needed according to the GCP and files appropriately in the study record
Maintains the study file record according to GCP
Maintains subject participant records according to GCP
Provides a list of all study participants to facility/practice management to avoid improper billing of lab tests or services covered under the research budget
Ensures appropriate storage, access, and maintenance of records pertaining to investigational product
Documents investigational product received dispensed, and returned to study sponsor according to GCP
Completes the clinical trials management system and electronic/paper case report forms in an accurate and timely manner
Attends Investigator Meetings as necessary
Other duties as assigned

Requirements

Bachelor's Degree or an equivalent combination of education and experience
Graduate of a technical program in healthcare (e.g. LVN/LPN, Medical Assistant or Dialysis Technician) AA in Life Sciences or other health related field
2 to 5 years' healthcare experience with Dialysis experience preferred
Research experience preferred
Willing to pursue CCRC or SoCRA certification when eligible
Current appropriate state licensure if applicable
Proficient with PCs and Microsoft Office applications
Good communication and organizational skills
Ability to work independently

Nice to have

Advanced Degree preferred
Dialysis experience preferred
Research experience preferred

What we offer

Healthcare
Continuing Education
Paid Time Off
Collaborative Environment
Additional Perks
401(k) Retirement Saving

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Clinical Research Coordinator II

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