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Clinical Research Coordinator III

1 month ago

Washington, Washington, D.C., United States MEDSTAR HEALTH Full time

We are actively recruiting for an experienced Clinical Research Coordinator III to join our Oncology research team at MedStar Health Research Institute in Washington, DC.

Under the guidance of the Clinical Trial Manager, the Clinical Research Coordinator (CRC) III functions independently and proficiently with minimal oversight and is responsible for the complete coordination of assigned clinical research activities of all phases and all levels of complexity, including investigator-initiated or other high profile research. Demonstrates competence in clinical research skills, problem solving, priority setting and supports less experienced staff. Required to enter study and/or research participant data into the Clinical Trial Management System (CTMS) as applicable.

Education
  • Bachelor's degree or an allied health required, or related professional degree and equivalent work experience required
Experience
  • Experience as a clinical research coordinator in the clinical research field required
  • 3-4 years Clinical research or related experience required
  • Research and/or work experiences that demonstrate aptitude for research facilitation required
Knowledge, Skills, and Abilities
  • Excellent verbal and written communication skills.
  • Strong communication and organizational skills.
  • Proficient computer skills.
Oversees, prepares, submits and maintains all regulatory submissions (e.g., new studies, annual review, amendments) accurately and within a timely manner; periodically self-audits records to ensure audit-readiness; ensures the appropriate delegation of study related tasks (i.e., Delegation of Authority).Possesses basic understanding of clinical trial endpoints and analytical ability sufficient to evaluate data.Oversees the informed consent process and reviews consent form with research participants and provides time for research participant to consider study participation; executes the informed consent process according to Good Clinical Practices (GCPs), procedures and other applicable rules, regulations and policies; educates new staff and research participates about protocol expectations and the conduct of clinical trials.Ensures all research participant encounters are updated as appropriate and within one (1) business day in a recognized electronic system/database (e.g., Clinical Trial Management System [CTMS]; enter data into various auditable databases or electronic data-capture systems (e.g., REDCap); oversees data entry and validation to ensure accuracy and completeness of the data collection process; supports data management process for clinical research projects, including addressing data queries and outstanding data queries from data managers, project statistician and sponsors; completes and submits case report forms on as close to aAttends investigator meetings as required or as requested by the investigator and assists the investigator in communication of study requirements to all individuals involved in the study and provides appropriate training for study teams members; documents date of training and signatures of study personnel trained on study specific training log as appropriate; alerts the investigator when the research participant's safety is in jeopardy, there is a protocol deviation, or when the research participant request premature study termination.Randomizes research participants using an interactive voice response system or other system as applicable and maintains all test article records as required by regulatory agencies and sponsor's requirements; prepares emergency use or expanded access reports as applicable.Optimizes the safety of research participants by monitoring and reporting any non-serious or serious adverse events to the investigators and other members of the study team; presents investigator with relevant information for determination of seriousness, causality and intervention; assists investigator (as appropriate) in classifying adverse events (e.g., serious, moderate, unexpected); acts on investigator's recommendation for adverse event intervention (e.g., stop test article, call research participant, re-test, treat); maintains follow-up to determine resolution of adverse event.Collaborates with the investigator and administrative leadership to prepare a categorized budget and justification; confirms the accuracy and completeness of budgeted costs; reviews and develops familiarity with the executed contract to ensure that the study is in compliance with all terms and conditions, health and safety precautions for research participants and any financial terms and conditions.Understands and complies with rules for billing Medicare, Medicaid and third party payors for services, drugs, devices, tests and procedures rendered in the clinical research context; oversees and ensure registration of each research participant according to the billing matrix/billing plan and ensures billing of study procedures and/or visits to the appropriate funding source.Supports an investigator-initiated IND or IDE study; prepares for internal or external audits and/or FDA inspections; assists and facilitates research and/or project team meetings; coordinates multi-center studies as applicable; acts as a liaison for research participants, investigators, sponsors and healthcare professionals and compose clear, precise and detailed correspondence; schedules and leads site qualification, study initiation, monitoring and close-out visits;.Generates, designs and makes recommendations to improve research participant recruitment and retention programs to study leadership; communicates challenges with recruitment and retention to study leadership.