Job Overview :
Covance is hiring a seasoned CRA II who will be dedicated to one of its key clients, a leading Life Science company with a more than 150-year history and core competencies in the areas of health care .
Join Covance and discover a wide-range of professional opportunities and be part of teams working on global, complex and challenging clinical trials.
Strong leadership teams will be there to support you in your role and work development.
What else do we offer? : Work environment in which work-life balance is expected, enabled, and supportedTransparency in decision-makingHighly supportive line managersEmployee's effort recognitionResponsibilities :
As a CRA II, you will be involved in all aspects of site management and monitoring activities for assigned applicable Phase I and all Phase II-IV clinical investigator sites.
Your responsabilities will include : Managing Investigator site and site activities; monitoring site data, to ensure patient safety and ethical and regulatory compliance.
Making certain the operational study execution is on track from site selection to site close out. Conducting Site Selection Visits to confirm the Investigator and Site Staff are qualified and have suitable resources and facilities to properly conduct the study Ensuring completion of site documents necessary for ethics and regulatory approval for site initiation within agreed upon timelines.
Working closely with Country Lead Monitors to ensure Investigator Agreements and budgets are executed for assigned study sites, and subsequently initiating payments at key milestones Training and supervising cross functional site personnel on study related procedures for the duration of the study Continuously assessing site performance, processes, qualifications of staff, and suitability of facilities to ensure adherence to study protocol, Sponsor requirements, regulatory and local legal requirements, as well as ICH-GCP Tracking enrollment activities and developing contingency plans to ensure site commitments are met Reviewing patient data at site to ensure safety of patient and patient data is consistent with what is reported in the case report form.
Serving as liaison between Investigator and Study Medical Expert to resolve any medical patient-related queries Ensuring sites have met all local and legal requirements to receive investigational product, study drug storage, and continually ensuring patient compliance with expected study drug dosing.
T Being responsible for study drug accountability at the site level and arranges for destruction of investigational product in accordance with local legal and regulatory requirements Ensuring applicable authorities are notified of study closure and final patient status in accordance with ICH and local regulations.
Periodically reviews Investigator Site File to ensure essential documents are maintained according to ICH and SOP requirements.
Training the Investigator and site staff on these strict regulations and procedures for timely reporting and as well as ensuring ongoing compliance.
Developing CAPAs Ensuring essential documents are appropriate and filed in a timely manner in the Investigator Site File Preparing, conducting and following up of Site Audits and Regulatory Inspections to ensure a successful outcome Education / Qualifications : Bachelor's Degree (or equivalent) Experience :
Extensive and relevant healthcare experience including around 2 to 3 years of monitoring & site management experience
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