NICHD Clinical Research Coordinator

Location : IC: NICHD Street: 10 Center Drive Bldg: 10 Room: 1 E 3330 City: Bethesda State & Zip: MD 20892

Weekly Hours PT: Less than 30 hours per week Total No. of Hours : 16

Overall Position Summary and Objectives

Provide support services to satisfy the overall operational objectives of the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The primary objective is to provide services and deliverables through performance of support services.

Min Education Bachelors

Payrate $45.44 on W2

Certifications & Licenses

• Minimum education is Bachelors or equivalent.

Skills (Ranked by Priority)

1. Strong communication skills both oral and written.

1 2 3 4 5 represents priority rankings where 1 is highest priority and 5 is lowest priority of those ranked

Software

• MS Office Suite

Field of Study

• Biology
• General Medical and Health Services

Statement of Work Details

Other

• Coordinate clinical admissions for research protocols This will include contact with families patients initial discussions of the clinical protocol with patient family guardian arranging travel scheduling and coordinating subspecialty appointments coordinating admissions data collection clinical and research samples coordinating with patient parent for release of pertinent medical records to the protocol team at NICHD 1
• Interact with patients parents families nursing staff physician staff social worker staff clerical staff laboratory staff and other clinical center professionals 2
• Serve as an associate investigator on protocols and obtain informed consent from patient parent legal guardian 3
• Coordinate and maintain research records in accordance with NIH guidelines
• Review patient care orders in CRIS for accuracy and contact the appropriate clinical fellow for any problems identified
• Review laboratory and clinical test results and report results to the attending physicians
• Participate in relevant clinical rounds
• Provide continuity of care to patients enrolled on assigned protocols
• Serve as a resource to patients and families enrolled in research protocols; facilitate communication with referring physician health care provider
• Communicate with the IRB annual reviews of the protocol; assist principal investigators on all matters that relate to communications with the IRB and the Office of the Clinical Director

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.
• Assists clinical and research staff ensure that Case Report Forms (CRFs) are completed and document changes in research participant condition adverse events concomitant medication use protocol compliance response to study drug and other required fields.
• Maintain and update files of all applicable regulatory documentation for Institutional Review Board (IRB).
• Participate in developing and maintaining research protocol documentation and operations.
• Assist researchers with study testing observations data entry and other duties associated with study sessions.

Collects research data and prepares information for inputs and analysis.

• Verify study participant information and collect data and results of testing.
• Assist staff develop assemble related documentation and maintain regulatory binders for all protocols.
• Perform accurate and timely data analysis report results and findings and respond to sponsor queries.
• 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.

• Assist researchers develop maintain and complete study data collection forms and source documents.
• Assist staff writing and editing clinical research protocols and informed consent forms (ICFs) based upon templates.
• 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.
• Assist researchers design patient Case Report Forms (CRFs).

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 laboratory information system and create spreadsheets and other reports for use in study analysis.
• Prepare patient charts for clinic days and provide initial or followup assessment forms patient labels most recent medication lists and lab and procedure printouts.
• Assist staff screen prospective study subjects and participate in scheduling participants for research visits and procedures.
• Schedule and coordinate outpatient and inpatient visits diagnostic studies and medical tests.
• Assist researchers with the collection and analysis of research data and samples.

Monitors subjects progress and reports adverse events.

• Liaison between the study subjects and the investigators concerning any problems or adverse events including out of range vitals etc.
• Observe data collection and monitoring of withdrawals and assist reporting deviations and adverse events.
• Assist staff writing progress reports and contributions to peerreviewed scientific manuscripts.
• Update and maintain logs and records of patient and family contacts.
• Provide continuity of care to patients enrolled on assigned protocols.

Supports assembly development and review of new research projects.

• Assist protocol staff submit initial applications amendments continuing reviews Adverse Events Serious Adverse Events protocol deviations and Safety Letters in accordance with local and federal guidelines.
• Assist researchers obtain IRB approval before any study related activities begin.
• Assist key research personnel ensure that clinical research activities are performed in accordance with federal state and institutional regulations policies and procedures.
• Assist researchers plan and coordinate the initiation of research study protocol and the implementation of operating policies and procedures.
• Assist researchers develop and maintain current and new research protocols.

Supports the creation and management of clinical websites and webbased tools.

Not applicable

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.
• Work with investigators to maintain Protocol Applications within the protocol management database system.
• Coordinate with relevant parties regarding data sharing plan review and tracking of data submission per approved plans.

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.
• Schedule and participate in monitoring and auditing activities and coordinate responses to audits.
• Assist staff on all facets of clinical studies including subject enrolment scheduling outpatient appointments and inpatient admissions travel arrangements investigation consent subject longitudinal monitoring study data sample collection and data entry.
• 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 site for monitoring visits and FDA audits.
• Assist staff on specimen handling storing packing and shipping as appropriate for the studies and protocols.