Responsibilities include:

Clinical:
Clinical duties include coordination of all study visits, including scheduling radiological scans, cardiograms, laboratory testing, chemotherapy infusion visits and all other required study procedures. Perform ECGs, research lab draws, processing and shipment of samples. Carries out all activities related to study implementation; screening, consenting and enrollment of participants, data collection and abstraction, follow up maintenance, through study close out.
Ability to work directly with sponsors and their representatives to ensure that study guidelines are followed, data and source properly collected and recorded in the multiple electronic data capture platforms.
Works directly with Principal Investigator, patients and clinical team within the Inova Schar Cancer Institute's Melanoma/Skin Cancer Clinic.
Knowledge of coordinating Phase I through IV clinical trials in a high enrolling environment on multiple studies with a various levels of complexity. Ability to be flexible with work hours if needed. Ability to work within different disease groups and provide backup to team members when necessary.
Regulatory:
Adheres to GCP, FDA, and Inova Health System guidelines when implementing research studies to ensure highest quality research and human subject protection within Inova Health System from site selection to study closure. Ensures study compliance with regulatory requirements, including amendments, continuing reviews and IRB submissions.

Financial:
Financial Management/Research Billing: Coordinates financial aspects of study implementation and management from protocol feasibility through study closeout per Inova Research Center and Research Department policies and guidelines.
Works directly with Inova Research Business office, Finance Team and Revenue and Billing team to ensure proper implementation of budget, coverage analysis and matrices.
Ensures accurate billing and payment for participants and sites. *
Quality Assurance/Regulatory Compliance: Utilizes and adheres to Inova standards, ICHGCP and DHHS (OHRP and FDA) guidelines to ensure the highest quality research and Human Subject Protection within Inova.\

Performs regular QA assessments of data and outcome measures.

Teamwork: Communicates effectively and works in collaboration with the research team in order to meet research study and departmental objectives. Respects and understands other clinical disciplines and departments.
Professional Development: Makes a continuous effort to foster self development, enhance work related skills and improve job performance and expertise.

Work Site Location : Inova Schar Cancer Institute, 8081 Innovation Park Drive, Fairfax, VA 22031
Schedule : Monday-Friday
Shift: Day
About Inova
Inova is Northern Virginia's leading nonprofit healthcare provider, recognized in 2019 and 2020 by U.S. News & World Report, which named Inova Fairfax Hospital the #1 hospital in the Washington, DC region. Each of Inova's five hospitals holds a 5-star rating from the Centers for Medicare & Medicaid Services (CMS), distinguishing Inova as the highest-rated large health system in the U.S., and the only system to have all hospitals receive five stars. All five Inova hospitals were awarded 'A' grades for the spring 2020 Leapfrog Hospital Safety Grades, recognizing Inova's achievements in protecting patients from harm and providing safer healthcare. Inova Fairfax Medical Campus was named to the Fortune/IBM Watson Health 100 Top Hospitals list, ranking in the top 10 nationwide among Major Teaching Hospitals. Our mission is to provide world-class healthcare - every time, every touch - to each person in every community we have the privilege to serve. Inova's 18,000 team members serve more than 2 million individuals annually through an integrated network of hospitals, primary and specialty care practices, emergency and urgent care centers, outpatient services and destination institutes. Inova is home to Northern Virginia's only Level 1 Trauma Center and Level 4 Neonatal Intensive Care Unit. Its hospitals have a total of 1,936 licensed beds. More information and statistics about Inova can be found at www.inova.org .