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8110 Gatehouse Road, Falls Church, VA 22042

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Clinical Research Regulatory Coord 2

Clinic And Schar Cancer 619863 Full Time 8081 Innovation Park Drive, Fairfax, VA, 22031, US
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Job Description

Clinical Research Positions available at The Inova Schar Early Phase Developmental Therapeutics Program.

The Inova Schar Cancer Institute is seeking new team members to support our clinical research program focused on early phase therapeutics.  Qualified candidates will have experience in clinical research as clinical research nurses or non-nurse coordinators having worked in an oncology and/or phase 1 research setting.   

Early Phase Developmental Therapeutics Program

Inova Schar Cancer Institute as a state-of-the-art cancer center in the Washington, DC metro area is dedicated to providing opportunities to participate in clinical research.  Early phase clinical trials examine novel therapies, with a focus on safety and important response signals.

Our Early Phase Developmental Therapeutics Program is led by the internationally known Dr. Nagla Abdel Karim and includes a team of doctors, specialists, PharmDs, nurses and care givers with significant expertise. The Program focuses on the latest drug discovery, advanced treatments and personalized approach to therapy. Molecular analysis of tumors is used to determine treatments that includes better options. Our program conducts broad phase I studies across disease boundaries and molecular targets. We are dedicated to our patients to bring them the best quality cancer care through an outstanding program that delivers new drugs that may eventually improve the management of cancer.

Goals

  • To provide novel clinical trials options to patients with cancer.
  • To provide Early-Phase Immunotherapy Trials.
  • To provide Early phase Genomically-Driven Clinical Trials to patients whose tumors harbor genetic mutations or aberrations. Our well-established Molecular Tumor Board provides great support to this group of patients.
  • To improve treatment options for patients with cancer through research.
  • To offer options for our cancer patients across the different tumor types who meet eligibility for our Phase I clinical trials.

The Clinical Research Regulatory Coordinator II (CRRC) plays a significant role in supporting a timely study start process and is responsible for collecting and provide sponsors with regulatory documents. Regulatory coordinators must have a working knowledge of institutional, federal and state policies. The position requires frequent interaction with Principal Investigators (PIs) and their research staff, as well as other Inova departments to ensure all regulatory documents and requirements are met and up to date. The CRRC II will submit regulatory documents to support initial reviews of studies, continuing reviews, and amendments. The CRRC II will respond to questions, generate reports, and maintain research files and documentation involving the regulatory requirements for the study/clinical trial. CRRCs are responsible for clinical studies through the regulatory portion of the trial; maintaining the regulatory integrity of assigned studies from approval to closure. The CRRC II works with other staff on regulatory/compliance issues and collaborates with investigators to resolve all regulatory inquiries.

Qualifications:

Education:

  • BA/BS/AS or experience equivalent to education

Certification:

  • Basic Life Support by American Heart Association
  • Must apply for research certification after 2 years of clinical research experience. e.g. CCRC, ACRP-CP, CCRP, etc.