Clinial Research Regulatory Research Specialist Inova Schar Cancer Institute Falls Church, Virginia
Coordinates or performs a wide variety of administrative and/or data management activities to support research department functions and research project goals.
Maintains and manages central electronic research regulatory files and other study related records.
Maintains a process to track each protocol through the submission and approval process.
Maintains a study regulatory binder/ebinder with all required documents prior to the start of a study.
May assist in preparation of documents, manuscripts/poster presentations for publication/presentation in peer-reviewed journals or conferences in conjunction with Principal Investigator and/or study team.
Assists the research director/manager with review, revision and development of departmental processes and procedures as needed.
Coordinates and tracks financial aspects of clinical trial implementation from study feasibility to study closure per departmental policies and guidelines.
In conjunction with the study team, may assist in development and negotiation of study budget.
Communicates and collaborates to ensure the Clinical Trial Agreement (CTA) receives the required signatures/reviews/sign-off and is consistent with Inova's requirements.
Submits CTA or financial amendments for approval.
Adheres to ICH-GCP DHHS (OHRP and FDA) and Inova Health System policies when implementing research studies to ensure highest quality research and human subject protection.
In collaboration with the research team, may assist with review of study protocols to determine feasibility (i.e. clinical, financial, and logistical) for site participation and provide feedback to PI and research manager/department director.
Coordinates, reviews and submits application packets to Regulatory Authorities (i.e. IRB, FDA, OHRP). Follows-up on review and approval of same. Provides departmental updates to management.
Participates in the orienting and training of new research staff as appropriate.
Leads other compliance initiatives, projects, and day to day support.
In collaboration with the study team, consistently ensures research department regulatory readiness for internal, external (Sponsor, FDA) audit visits and routine study monitor visits.
Communicates effectively and works in collaboration with the research team in order to meet research study and department objectives. Demonstrates respect and understanding of other clinical disciplines and departments.
Volunteers and/or displays flexibility and willingness to perform tasks outside own area of responsibility when requested.
Attends and participates in team and study review meetings, financial meetings as determined by department director/manager.
Communicates clearly to avoid misunderstanding/misinterpretation and asks for clarification or verification of information and /or expectations.
Changes focus and direction to meet the workload priorities of the team and department as needed.
Makes a continuous effort to foster self-development, enhance work related skills and improve job performance and expertise.
Establishes goals for self-development using available resources and knowledge of personal strengths and limitations.
Acquires new and/or updated knowledge in area of expertise relevant to current position and responsibilities by participation in professional associations and attendance at meetings and conferences/lectures, attendance at Education Research related Webinars, journal clubs or Inova Grand Rounds.
Internal Number: 57144BR
About Inova Health System
Inova is a global leader in personalized health, which leverages precision medicine to predict, prevent and treat disease, enabling individuals to live longer, healthier lives. At Inova, we serve more than two million people each year from throughout the Washington, DC, metro area and beyond. Inova's mission is to improve the health of the diverse community it serves through excellence in patient care, education and research. At Inova, more than 16,000 employees demonstrate their commitment every day to providing the community with expert, world-class, compassionate patient care.