Clinical Research Coordinator,

Job Description

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.

Travel Requirements 0 - 10% Salary Grade Job Requirements

Certification from a Clinical Research Association