Clinical Research Coordinator (52787)

Position Objective: The Clinical Research Coordinator will provide support services to satisfy the overall operational objectives of the National Institute of Neurological Disorders and Stroke within the National Institutes of Health (NIH).

Duties and Responsibilities:

• Supports clinical staff develop, implement and maintain clinical research data files and materials.
• Assist preparing and submitting for review accurate source documents related to all research procedures.
• Participate in developing and maintaining research protocol documentation and operations.
• Collects research data and prepares information for inputs and analysis.
• Verify study participant information and collect data and results of testing.
• Perform accurate and timely data analysis, report results and findings and respond to sponsor queries.
• Supports the development of forms and questionnaires.
• 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.
• Retrieve research related information from medical records, hospital information system and information system and create spreadsheets and other reports for use in study analysis.
• Maintain Neurogenetics patient records; retrieve as requested by staff.
• Monitors subject's progress and reports adverse events.
• Assist staff writing progress reports and contributions to peer-reviewed scientific manuscripts.
• Update and maintain logs and records of patient and family contacts.
• Supports assembly, development and review of new research projects.
• Assist researchers plan and coordinate the initiation of research study protocol and the implementation of operating policies and procedures.
• Maintain an extensive clinical database, helping in the design and implementation of clinical trials, organizing genetic field studies, and helping in the preparation of annual reports. 1
• Supports the creation and management of clinical websites and web-based tools.
• Work with investigators to Assist researchers submit protocol packages, actions and applications to IRB using the designated protocol tracking and management databases system.
• Organizes and performs clinical research, utilizing internet and other available clinical resources.
• Monitor electronic medical record system to ensure necessary components are present and complete such as data collection forms, progress notes, participant information forms and diagnostic test completion forms.
• Update annual status of recruitment/enrollment in NIH Human Subjects Reporting System.
• Provides assistance to staff in the collection, development and quality control of essential clinical research efforts.
• Participate in coordination and management of most daily activities of the study and ensure that study activities follow established protocol, Standard Operating Procedures (SOP), and utilizes approved forms, templates and practices.
• Assist staff on all facets of clinical studies including subject enrollment, scheduling outpatient appointments and inpatient admissions, travel arrangements, investigation consent, subject longitudinal monitoring, study data, sample collection and data entry.
• Receive requests for scheduling outpatient appointments and inpatient admissions from Neurogenetics staff and confirm receipt of medical records before scheduling patients.
• Contact patients by telephone to schedule appointments or admission dates; arrange patient travel and accommodations if requested by staff. 3
• Enter patient information into database and maintain clinic and admission schedules and notify Neurogenetics staff of upcoming clinic and admission schedules. 2
• Be available to staff and patients to answer questions about scheduling.
• Meet with lab members to present updates
• Work products and documents related to requests for scheduling outpatient appointments and inpatient admissions from Neurogenetics staff and confirm receipt of medical records before scheduling patients.
• Work products and documents related to contacting patients by telephone to schedule appointments or admission dates; arrange patient travel and accommodations if requested by staff.
• Work products and documents related to entering patient information into database and maintaining clinic and admission schedules and notifying Neurogenetics staff of upcoming clinic and admission schedules.
• Work products and documents related to maintaining Neurogenetics patient records , retrieve as requested by staff.
• Work products and documents related to being available to staff and patients to answer questions about scheduling.
• Work products and documents related to maintaining an extensive clinical database, helping in the design and implementation of clinical trials, organizing genetic field studies, and helping in the preparation of annual reports.

Basic Qualifications:

• Master's degree in physical sciences or equivalent
• Clinical Trial Management System (CTMS)
• Skilled in Microsoft Office

Preferred Qualifications:

• Ability to communicate effectively, orally and in writing, with non-technical and technical staff
• Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects

*This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job, email us at [click to reveal email address]recruiting@gapsi.com. You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by law.

This position is contingent upon contract award.