Clinical Research Scientist

Clinical Research ScientistIntegrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.Title: Clinical Research Scientist Duration: 12 Months (Possibility of Extension) Location Woodcliff Lake NJJob Responsibilities:Assist in the planning, implementation, managing, and reporting of Phase I-III clinical studiesPrepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, ISE, Investigator Brochure, etc)Performs literature search and data analysis to address research questionsIn collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.)Assisting in database cleaning, review of study results, and interpretation of resultsAdhering to key performance indicators for clinical study development, conduct, and reportingIndividual contributor with specialized knowledgePresents concepts, facts, and reports and advises on key trends and issuesTroubleshooting routine site inquiriesWork is completed under limited supervisionSupports the planning, execution and reporting of clinical programs/trialsMay handle multiple protocols simultaneouslyContributes to risk resolution by escalating and monitoring project risksQualifications:Minimum of 2-5 years of experience in clinical research in the pharmaceutical industryA 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 requirementsWorking knowledge of the IND/NDA/CTD/MAA process acquired through direct industrial experience preferredKnowledge of medical, scientific and clinical research techniques in the oncology therapeutic area;Bachelor's Required. Doctoral (PharmD or PhD) or MD degree preferred.Additional Information:Feel free to forward my email to your friends/colleagues who might be available. We do offer referral bonus Thank you for your time and consideration. I look forward to hearing from you!Kind RegardsRuchi KumariClinical RecruiterCertified MBE | GSA - Schedule 66 I GSA - Schedule 621IBy clicking the link above or any third-party link within this posting, you are leaving this site and going to a third-party website where the third-party website's terms and privacy policy apply