Senior Clinical Trial Associate - Now Hiring
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The Senior Clinical Trial Associate supports the Clinical Trial Manager and Study Team with all operational and trial-related activities from study start-up to close out.
This is a full-time, exempt, field-based position reporting to the Clinical Trial Manager.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Set up trial meetings, minutes, manages rosters
- Support of documents creation, review, and feedback coordination
- Collate and track information and timelines (feasibility, CDA)
- Lead TMF review and tracking of CRO
- Tracking of study tools - internal Novocure trackers and CRO trackers
- Manage study-related supplies and study-related material requests
- Manage Compliance reports
- Lead coordination of document translation management
- Participate in the review of visit reports
- Participate or lead on projects for the overall clinical operations team
- Training incoming employees - may be onboarding mentor for incoming employees
QUALIFICATIONS/KNOWLEDGE:
- Bachelor's degree or equivalent preferably in Nursing, Medicine or other Life Sciences, or RN degree from an accredited school or equivalent
- Minimum of 3 years of clinical trial experience in various clinical trial activities from initiation to closure. On-site monitoring preferred (both CRO and industry experience are acceptable)
- Detailed knowledge of Clinical Trial Process, including ICH/GCP guidelines
- Experience in identifying potential deficiencies in the trial progress and assisting in/suggesting corrective and preventive actions (CAPA)
- Experience in TMF set-up, maintenance, and periodic reviews
- Experience in review and tracking of regulatory documentation for successful implementation of clinical trials
- Experience as CRA (working for CRO or sponsor company) would be an advantage
- Familiarity with clinical research in Oncology
- Familiarity with Medical Device regulations, clinical trials, and ISO
OTHER:
- Ability to lift up to 20lbs or 9kg
- Fluency in English
Novocure is taking a responsible approach to creating environments that allow us to strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy.
As part of our commitment to health and safety, COVID-19 vaccines are required for our current U.S. employees.As an Equal Opportunity Employer it is our policy to provide reasonable accommodations to any qualified individual, who, because of a medical condition, or sincerely held religious belief/practice, receives an exemption from the vaccination requirement, if such accommodation would not result in an undue hardship for the company.
For more information regarding the Novocure's COVID-19 vaccination requirement, exemptions, and verification of vaccination status please ask the Talent Acquisition Team.
ABOUT NOVOCURE:
Our vision
Patient-forward: aspiring to make a difference in cancer.
Our patient-forward mission
Together with our patients, we strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy.
Our patient-forward values
- innovation
- focus
- drive
- courage
- trust
- empathy
#LI-SM1