Senior Clinical Trial Associate
Job description
Location: Boston, MA, US, 02114 Miami, FL, US, 33138 Philadelphia, PA, US, 19104 Orlando, FL, US, 32789 Charlotte, NC, US, 28105 Parsippany, NJ, US, 07005 Atlanta, GA, US, 30301
Description:

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 and reports to the Clinical Trial Manager.


ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Set up trial meetings, meeting minutes, manages rosters
  • Support for documents creation, review, and feedback coordination
  • Quality control of TMF, CTMS
  • Collate and track information and timelines (feasibility, CDA)
  • Support 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
  • May support coordination of document translation management
  • Participate in projects for the overall clinical operations team

QUALIFICATIONS/KNOWLEDGE:

  • Bachelor's degree or equivalent; preferably in Nursing, Medicine, or other Life Sciences. Or RN degree from an accredited school or equivalent work experience required
  • Minimum of 1-year 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, Oncology a plus
  • Familiarity with Medical Device regulations, clinical trials, and ISO

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

#LI-REMOTE



Nearest Major Market: Boston

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Company details

Employee

1001 to 5000

Company Description
In 2000, Yoram Palti, our founder and professor emeritus of physiology and biophysics at the Technion — Israel Institute of Technology, sought to leverage his expertise in biophysics to develop a new way to treat solid tumor cancers that would destroy tumor cells while sparing healthy tissue and avoiding many of the life-altering side effects of existing cancer therapies. He set up a laboratory in his basement to explore the potential of electric fields as a treatment for solid tumors. Professor Palti founded Novocure to provide patients with a new cancer treatment based on his hypothesis, since proven, that alternating electric fields, when applied at specific frequencies, can disrupt cancer cell division and cause cancer cell death. This innovative treatment, Tumor Treating Fields, is a completely different approach to cancer therapy. “Nobody understood what I was doing,” Professor Palti said of his early development of Tumor Treating Fields. We launched Optune® – our Tumor Treating Fields delivery system for glioblastoma (GBM) – in the United States for the treatment of recurrent glioblastoma in 2011. In October 2015, we received U.S. Food and Drug Administration (FDA) approval to market and sell Optune for the treatment of adult patients with newly diagnosed GBM in combination with temozolomide. Our currently active markets include United States, Germany, Austria, Switzerland, Sweden, Israel and Japan. The science of Tumor Treating Fields has the potential to extend beyond GBM. We have six ongoing or completed phase 2 pilot trials for brain metastases, non-small cell lung cancer (NSCLC), pancreatic cancer, ovarian cancer, liver cancer and mesothelioma. We presented our phase 2 pilot data in pancreatic and ovarian cancers at our research and development day on Dec. 12, 2016. In 2016, we began our phase 3 pivotal trial in brain metastases originating from NSCLC. In 2017, we started our phase 3 pivotal trials in NSCLC and pancreatic cancer. In 2019, we initiated our phase 3 pivotal trial in recurrent, platinum-resistant ovarian cancer. Internationally, more than 20 institutions are studying the effects of Tumor Treating Fields in cancer treatment. Our company began with a patient-forward approach that continues to drive our mission today. With more than 19 years of research and many significant milestones, we have established ourselves as an innovator in oncology dedicated to improving the lives of cancer patients.
Company ratings
  • Overall
    3.0
  • Company & Benefits
    3.2 / 5
  • Culture & Values
    3.0 / 5
  • Career Opportunities
    2.8 / 5
  • Work/Life Balance
    2.8 / 5
  • Senior Management
    2.5 / 5
Company reviews
"Productive and fun place to work. "
Former EmployeeDevelopment Intern
I had a great internship experience with Novocure. The internship program was well put together. Novocure wanted interns to succeed and learn. They always explained the bigger picture and the impact our work had.

"People arent interested in doing their job"
Former EmployeeSourcing Manager
HR isnt interested in hearing to your issues The team is scattered around the world without any efficiency in collaborating virtually creating a whole mess.

"Growing company with growing pains"
Current EmployeeCoordinator
Novocure offers great benefits, which gets many employees in the door. However, the company is understaffed when compared to its growth, and many of its systems are antiquated, which leads to extra work for the employees it does have. The salaries are low compared to similar jobs in this field, and there are few opportunities for advancement. The company overall has a good work/life balance, and is a good way to start in a healthcare field for those with no experience.
Pros:
Cons:

"Decent company until vaccine mandate took effect"
Former EmployeeReimbursement Specialist
After 3 years of employment I was Terminated for refusing the Covid vaccine. Totally out of alignment with company culture. Full time remote employee and they felt they couldn’t accommodate employees who refused the vaccine. Totally disappointed in this company for that reason.
Cons: