Consultant Clinical Research Associate SynCardia Systems
THIS JOB HAS EXPIRED Clinical Monitoring Responsibilities
Under a Consulting Services Agreement
CONSULTANT will provide clinical monitoring services to SYNCARDIA to verify that:
The rights and well-being of human subjects are protected.
The reported study data are accurate, complete, and verifiable from source documents.
The conduct of the study is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirement(s).
Selection and Qualifications of Monitors
CONSULTANT shall be appropriately trained, and have the scientific and/or clinical knowledge needed to monitor the trial adequately.
The qualifications of the clinical monitors shall be documented and provided to SYNCARDIA.
Clinical monitors shall be thoroughly familiar with the investigational product(s), the protocol, written informed consent form and any other written information to be provided to subjects, SYNCARDIA?s SOPs, GCP, and the applicable regulatory requirement(s).
In the performance of the duties detailed in this Agreement, CONSULTANT agrees to:
Establish an independent business (LLC)
Provide contemporary computers, including internet access capability
Provide own internet access, printers, and fax machines
Use the SynCardia-provided email domain
Follow the SynCardia travel policy, including the use of the SynCardia travel arrangement system
Submit expenses in accordance with the SynCardia expense reporting policy
Report time using the selected time tracking tool
Order office supplies through SynCardia
The clinical monitors, in accordance with SYNCARDIA?s requirements, shall ensure that the study is conducted and documented properly by carrying out the following activities when relevant and necessary to the trial and the trial site:
Acting as the main line of communication between SYNCARDIA and the investigator.
Verifying that the investigator has adequate qualifications and resources and these remain adequate throughout the trial period, and that the staff and facilities, including laboratories and equipment, are adequate to safely and properly conduct the trial and these remain adequate throughout the trial period.
Verifying, for the product(s) if applicable:
That storage times and conditions are acceptable, and that supplies are sufficient throughout the trial.
That the investigational product(s) are supplied only to subjects who are eligible to receive it and as specified in the protocol.
That subjects are provided with necessary instruction on properly using the product(s).
That the receipt and use of the product(s) at the study sites are controlled and documented adequately.
Verifying that the investigator follows the approved protocol and all approved amendment(s), if any.
Verifying that written informed consent was obtained before each subject's participation in the trial.
Ensuring that the investigator receives the current Investigator's Brochure (if applicable), all documents, and all trial supplies needed to conduct the study properly and to comply with the applicable regulatory requirement(s).
Ensuring that the investigator and the investigator's trial staff are adequately informed about the study.
Verifying that the investigator and the investigator's study staff are performing the specified study functions, in accordance with the protocol and any other written agreement between SYNCARDIA and the investigator/institution, and have not delegated these functions to unauthorized individuals.
Verifying that the investigator is enrolling only eligible subjects.
Reporting the subject recruitment rate.
Verifying that source data/documents and other study records are accurate, complete, kept up-to-date, and maintained.
Verifying that the investigator provides all the required reports, notifications, applications, and submissions, and that these documents are accurate, complete, timely, legible, dated, and identify the study.
Checking the accuracy and completeness of the CRF entries, source data/documents, and other trial-related records against each other. The monitor specifically should verify that:
The data required by the protocol are reported accurately on the CRFs and are consistent with the source data/documents.
Any dose and/or therapy modifications are well documented for each of the trial subjects.
Adverse events, concomitant medications, and intercurrent illnesses are reported in accordance with the protocol on the CRFs.
Visits that the subjects fail to make, tests that are not conducted, and examinations that are not performed are clearly reported as such on the CRFs.
All withdrawals and dropouts of enrolled subjects from the trial are reported and explained on the CRFs.
Informing the investigator of any CRF entry error, omission, or illegibility. The monitor should ensure that appropriate corrections, additions, or deletions are made, dated, explained (if necessary), and initialed by the investigator or by a member of the investigator's trial staff who is authorized to initial CRF changes for the investigator. This authorization should be documented.
Determining whether all adverse events (AEs) are appropriately reported within the time periods required by GCP, the ICH Guidance for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, the protocol, the IRB/IEC, SYNCARDIA, and the applicable regulatory requirement(s).
Determining whether the investigator is maintaining the essential documents.
Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator and taking appropriate action designed to prevent recurrence of the detected deviation.
The monitor shall follow SYNCARDIA written SOPs.
The monitor will submit a written report to SYNCARDIA after each study site visit or study-related communications.
Reports should include the date, site, name of the monitor, and name of the investigator or other individual(s) contacted.
Reports should include a summary of what the monitor reviewed and the monitor's statements concerning the significant findings/facts, deviations and deficiencies, conclusions, actions taken or to be taken, and/or actions recommended to secure compliance.
The review and follow-up of the monitoring report by SYNCARDIA should be documented by SYNCARDIA?s designated representative.
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Tucson, AZ 85713
THIS JOB HAS EXPIRED