Vern Hackworth Email & Phone Number

Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors. Responsible for all aspects of site management as prescribed in the project plansGeneral On-Site Monitoring Responsibilities: Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the studyEnsure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirementsEnsure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document reviewMonitor data for missing or implausible data Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policyEnsure audit readiness at the site levelTravel, including air travel, may be required and is an essential function of the jobPrepare accurate and timely trip reportsAct as contact for clinical trial supplies and other suppliers (vendors) as assignedResponsible for all aspects of registry management as prescribed in the project plansUndertake feasibility work when requestedConduct, report and follow-up on Quality Control (QC) visits when requested

Dublin, Ie

Responsibilities include identification, selection, initiation, and close-out of appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, ICON SOPs/WPs, applicable regulations and the principles of ICH-GCP. Involvement when required in other areas of study management and staff training and contribute to the culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs. Recognize, exemplify and adhere to ICON’s values which center around a commitment to People, Clients and Performance.

Home-based Senior CRA. Routine site monitoring visits which includes: consent form review, study procedures, drug inventory, case report form review, data alerts and clarifications, verification of source documentation for investigational sites, monitoring on a monthly basis, tracking of regulatory documents and IRB submissions, assess and determine eligibility criteria for all subjects screened,

Kenilworth, New Jersey, Us

Home-based 2-3 days per week. Routine site monitoring visits which includes: consent form review, study procedures, drug inventory, case report form review, data alerts and clarifications, verification of source documentation for investigational sites, monitoring on a monthly basis, tracking of regulatory documents and IRB submissions, assess and determine eligibility criteria for all subjects screened, process of grant payments. (45-55% travel)

Princeton, New Jersey, Us

Routine site monitoring visits for Hyperphosphatemia Study (Renal Dialysis) with 6 investigational sites which includes: consent form review, study procedures, drug inventory, case report form review, data alerts and clarifications, verification of source documentation for investigational sites, monitoring on a monthly basis, tracking of regulatory documents and IRB submissions, assess and determine eligibility criteria for all subjects screened and informed consent review. (Approximately 75% travel)