Concentric Methods is seeking a Clinical Research Coordinator to join our team in Rockville, MD in support of the NIH.

Responsibilities:

• Supports clinical staff develop, implement, and maintain clinical research data files and materials.
• Participate in developing and maintaining research protocol documentation and operations.
• Collects research data and prepares information for inputs and analysis.
• Assist staff develop, assemble related documentation, and maintain regulatory binders for all protocols.
• Set up, format, and enter data into spreadsheets to analyze information and create reports.
• Enter data into research databases, systems, and applications for ongoing studies.
• Supports the development of forms and questionnaires.
• Review draft protocols, case report forms, and manuals of operations for clarity, and completeness.
• Work with staff on the design, development, and preparation of documents such as spreadsheets, letters, rosters, agendas, presentations, and meeting minutes/summaries.
• Supports the collection of data from patient charts, medical records, interviews, questionnaires, and diagnostic tests.
• Assist researchers with clinical research protocols and common data elements
• Monitors subject's progress and reports adverse events.
• Observe data collection and monitoring of withdrawals and assist in reporting deviations and adverse events.
• Provide and maintain a process for monitoring adverse events
• Supports assembly, development, and review of new research projects.
• Review initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
• Supports the creation and management of clinical websites and web-based tools.
• Assist researchers register studies on clinicaltrials.gov.
• Assist researchers and monitor registration and reporting for clinical trials (e.g., clinicaltrials.gov)
• Organizes and performs clinical research, utilizing the internet and other available clinical resources.
• Coordinate with relevant parties regarding data sharing plan review and tracking of data submission per approved plans.
• Maintain and organize an online resource of documentation regarding clinical trials, including Standard Operating Procedure documents for all tasks related to the handling of clinical trials.
• Update the annual status of recruitment/enrollment in the NIH Human Subjects Reporting System.
• Collaborate with data coordinating center on clinical research using available clinical resources and data tools.
• Provides assistance to staff in the collection, development, and quality control of essential clinical research efforts.
• Assess protocols and studies for regulatory compliance, adherence to IRB approvals, and Federal standards, such as HIPAA, human subject ethics, privacy, etc., and generate quality assurance reports.
• Assist researchers coordinate, facilitate, and prepare sites for monitoring visits and FDA audits.
• Supports clinical staff develop, implement, and maintain clinical research data files and materials.
• Collaborate with data coordination center and project sites to develop, implement, and maintain clinical research data files and materials.
• Maintain research protocol documentation and operations.
• Develops and facilitates training for new research coordinators and mentors researchers in Good Clinical Practices.
• Organize, prepare, and distribute informational materials and provide support to the educational mission of the study.
• Mentor new clinical research coordinators on all aspects of research support.

Cape Fox Corporation, its subsidiaries, and affiliates provide equal employment opportunities to all persons and prohibit employment decisions on the basis of race, religion, color, creed, national origin, sex, age, disability, political affiliation, protected veteran status, or sexual orientation. Cape Fox Corporation, its subsidiaries, and affiliates offer preference to Cape Fox Corporation shareholders, descendants, and other Native Americans pursuant to Public Law 100-241.