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Associate Director Clinical Research- Oncology

System One

This is a Contract position in Woodcliff Lake, NJ posted March 28, 2020.

Associate Director Clinical Research
– Oncology Title: Associate Director, Clinical Research
– Oncology Hours: Full Time, M-F Responsibilities: Assist the Clinical Lead and/or Study Director in the planning and implementation, execution, day to day managing and reporting of clinical trials.

Assisting with the preparation of the clinical trial synopses, protocols, protocol amendments, drug development plans, clinical research forms, Investigator Brochure, Clinical Study Report, etc.

Training new CRO monitors and CRAs on protocol and processes Assisting with the preparation of the NDA documents Preparing clinical sections of IND annual safety report and annual Investigator brochure updates Assist with the database cleaning (eligibility listings, patient profiles, listings, laboratory results, etc.) Assisting with the preparation of the publications (abstracts, articles, etc.) pertinent to the study Assisting with the database cleaning (eligibility listings, patient profiles, listings, laboratory results, etc.) Assisting with the preparation of the publications (abstracts, articles, etc.) pertinent to the study Qualifications: New Entrants to Pharma: MD Board Certified or Board Eligible in Hematology and/or Oncology with an understanding of the fundamentals of clinical development; In lieu of clinical trial research experience will consider substantial academic Oncology research experience Ph.D.

or PharmD with 5 years of clinical research in the pharmaceutical industry A thorough understanding of clinical research methodology including study design, protocol writing and CRF preparation is required as is a knowledge of GCP and local regulatory requirements Working knowledge of the IND/NDA process acquired through direct industrial experience is required Knowledge of medical, scientific and clinical research techniques in assigned therapeutic area Joule, a System One division is a leader in specialized workforce solutions and integrated services.

With more than 6,000 employees and roughly 50 offices throughout the U.S.

we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services.

For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.