NICHD Clinical Research Coordinator

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

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

Overall PositionSummary and Objectives

Provide supportservices to satisfy the overall operational objectives of theEunice Kennedy Shriver National Institute of Child Health and HumanDevelopment. The primary objective is to provide services anddeliverables through performance of support services.

Min Education Bachelors

Payrate $45.44 on W2

Certifications & Licenses

• Minimum education is Bachelors orequivalent.

Skills(Ranked by Priority)

1. Strong communication skills both oral andwritten.

1 2 3 4 5represents priority rankings where 1 is highestpriority and 5 is lowest priority of thoseranked

Software

• MS OfficeSuite

Field ofStudy

• Biology
• General Medical and Health Services

Statement of WorkDetails

Other

• Coordinate clinical admissions for research protocolsThis will include contact with families patients initialdiscussions of the clinical protocol with patient family guardianarranging travel scheduling and coordinating subspecialtyappointments coordinating admissions data collection clinical andresearch samples coordinating with patient parent for release ofpertinent medical records to the protocol team at NICHD1
• Interact with patientsparents families nursing staff physician staff social worker staffclerical staff laboratory staff and other clinical centerprofessionals 2
• Serve as anassociate investigator on protocols and obtain informed consentfrom patient parent legal guardian 3
• Coordinate and maintain research records in accordancewith NIH guidelines
• Review patient care ordersin CRIS for accuracy and contact the appropriate clinical fellowfor any problems identified
• Review laboratoryand clinical test results and report results to the attendingphysicians
• Participate in relevant clinicalrounds
• Provide continuity of care to patientsenrolled on assigned protocols
• Serve as aresource to patients and families enrolled in research protocols;facilitate communication with referring physician health careprovider
• Communicate with the IRB annualreviews of the protocol; assist principal investigators on allmatters that relate to communications with the IRB and the Officeof the Clinical Director

Supports clinical staff develop implement andmaintain clinical research data files andmaterials.

• Assistpreparing and submitting for review accurate source documentsrelated to all research procedures.
• Assistsclinical and research staff ensure that Case Report Forms (CRFs)are completed and document changes in research participantcondition adverse events concomitant medication use protocolcompliance response to study drug and other requiredfields.
• Maintain and update files of allapplicable regulatory documentation for Institutional Review Board(IRB).
• Participate in developing andmaintaining research protocol documentation andoperations.
• Assist researchers with studytesting observations data entry and other duties associated withstudy sessions.

Collectsresearch data and prepares information for inputs andanalysis.

• Verify studyparticipant information and collect data and results oftesting.
• Assist staff develop assemble relateddocumentation and maintain regulatory binders for allprotocols.
• Perform accurate and timely dataanalysis report results and findings and respond to sponsorqueries.
• Set up format and enter data intospreadsheets to analyze information and create reports.
• Enter data into research databases systems andapplications for ongoing studies.

Supports the development of forms andquestionnaires.

• Assistresearchers develop maintain and complete study data collectionforms and source documents.
• Assist staffwriting and editing clinical research protocols and informedconsent forms (ICFs) based upon templates.
• Review draft protocols case report forms and manuals ofoperations for clarity and completeness.
• Workwith staff on the design development and preparation of documentssuch as spreadsheets letters rosters agendas presentations andmeeting minutes/summaries.
• Assist researchersdesign patient Case Report Forms (CRFs).

Supports the collection of data from patientcharts medical records interviews questionnaires and diagnostictests.

• Retrieve researchrelated information from medical records hospital informationsystem and laboratory information system and create spreadsheetsand other reports for use in study analysis.
• Prepare patient charts for clinic days and provideinitial or followup assessment forms patient labels most recentmedication lists and lab and procedure printouts.
• Assist staff screen prospective study subjects andparticipate in scheduling participants for research visits andprocedures.
• Schedule and coordinate outpatientand inpatient visits diagnostic studies and medicaltests.
• Assist researchers with the collectionand analysis of research data and samples.

Monitors subjects progress and reports adverseevents.

• Liaison betweenthe study subjects and the investigators concerning any problems oradverse events including out of range vitals etc.
• Observe data collection and monitoring of withdrawals andassist reporting deviations and adverse events.
• Assist staff writing progress reports and contributionsto peerreviewed scientific manuscripts.
• Updateand maintain logs and records of patient and familycontacts.
• Provide continuity of care topatients enrolled on assigned protocols.

Supports assembly development and review of newresearch projects.

• Assistprotocol staff submit initial applications amendments continuingreviews Adverse Events Serious Adverse Events protocol deviationsand Safety Letters in accordance with local and federalguidelines.
• Assist researchers obtain IRBapproval before any study related activities begin.
• Assist key research personnel ensure that clinicalresearch activities are performed in accordance with federal stateand institutional regulations policies and procedures.
• Assist researchers plan and coordinate the initiation ofresearch study protocol and the implementation of operatingpolicies and procedures.
• Assist researchersdevelop and maintain current and new research protocols.

Supports the creation and managementof clinical websites and webbased tools.

Not applicable

Organizes andperforms clinical research utilizing internet and other availableclinical resources.

• Monitor electronic medical record system to ensurenecessary components are present and complete such as datacollection forms progress notes participant information forms anddiagnostic test completion forms.
• Work withinvestigators to maintain Protocol Applications within the protocolmanagement database system.
• Coordinate withrelevant parties regarding data sharing plan review and tracking ofdata submission per approved plans.

Provides assistance to staff in the collectiondevelopment and quality control of essential clinical researchefforts.

• Participate incoordination and management of most daily activities of the studyand ensure that study activities follow established protocolStandard Operating Procedures (SOP) and utilizes approved formstemplates and practices.
• Schedule andparticipate in monitoring and auditing activities and coordinateresponses to audits.
• Assist staff on allfacets of clinical studies including subject enrolment schedulingoutpatient appointments and inpatient admissions travelarrangements investigation consent subject longitudinal monitoringstudy data sample collection and data entry.
• Assess protocols and studies for regulatory complianceadherence to IRB approvals and Federal standards such as HIPAAhuman subject ethics privacy etc. and generate quality assurancereports.
• Assist researchers coordinatefacilitate and prepare site for monitoring visits and FDAaudits.
• Assist staff on specimen handlingstoring packing and shipping as appropriate for the studies andprotocols.