Clinical Research Coordinator
1 month ago
Location : IC:NHGRI Street: 31 Center Dr.Bldg.: 31 Room:B1B54 City: Bethesda State& Zip: MD 20892
WeeklyHours FT: 3040 hours per week Total No. ofHours : 40
Overall PositionSummary and Objectives
The positionwill independently provide support services to satisfy the overalloperational objectives of the National Human Genome ResearchInstitute (NHGRI)
Min EducationBachelors
Payrate $49.34hourly on W2
Certifications& Licenses
- Mastersdegree in a related discipline and six years experience
- Masters degree in a related discipline and 2 years ofexperience
Skills (Rankedby Priority)
- Interviewing
- Screening
- Obtaining Informed Consent
- DataIntegrity
- Project Management
- Scheduling
1 2 34 5 represents priority rankings where 1 ishighest priority and 5 is lowest priority of thoseranked
Software
- MS Office
Fieldof Study
- ClinicalPsychology
- Counselling Psychology
- Clinical Psychology
- CounsellingPsychology
Statement ofWork Details
Other
- Coordinate participant visits including schedulingappointments arranging admissions and incentivization.1
- Coordinate biospecimencollection and processing of samples.
- Collaborate with research team to evaluate each case;evaluate all study results.
- Maintaincommunication with participants and their families.
- Provide referrals to mental health resources andproviders. 5
- Performmaintenance of research databases and participant research papercharts.
- Work with staff on study relatedactivities for other ongoing research protocols within the SocialNetwork Methods Section.
- Perform literaturesearches and reviews in the field of behavioural and socialsciences in order to design a research study.
- Work with team to plan and implement social andbehavioural research projects. 4
- Work withteam to develop survey instruments.
- Work withteam on the development of behavioural intervention materials andhealth communications.
- Coordinate recruitmentof study subjects for trials.
- Collect datathrough interviews with participants.2
- Monitor data collectionand communicate with participants as needed for behavioural andsocial science research. 3
- Work with team to enter organize and storedata.
- Perform preliminary analyses of data toaddress behavioural research questions.
- Coauthor reports and research papers for publication inpeerreviewed journals.
- Prepare scientificslides graphics and PowerPoint presentations.
- Present data at conferences.
- Contribute to the development of new studyprotocols.
Supportsclinical staff develop implement and maintain clinical researchdata files and materials.
- Assist preparing and submitting for review accuratesource documents related to all research procedures.
- Maintain and update files of all applicable regulatorydocumentation for Institutional Review Board (IRB).
- Participate in developing and maintaining researchprotocol documentation and operations.
Collects research data and prepares informationfor inputs and analysis.
- Set up format and enter data into spreadsheets to analyzeinformation and create reports.
- Enter datainto research databases systems and applications for ongoingstudies.
Supports thedevelopment of forms and questionnaires.
- Assist staff writing and editing clinicalresearch protocols and informed consent forms (ICFs) based upontemplates.
- Review draft protocols case reportforms and manuals of operations for clarity andcompleteness.
- Work with staff on the designdevelopment and preparation of documents such as spreadsheetsletters rosters agendas presentations and meetingminutes/summaries.
Supports the collection of data from patientcharts medical records interviews questionnaires and diagnostictests.
- Assist researcherswith the collection and analysis of research data andsamples.
Monitors subjectsprogress and reports adverse events.
- 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.
Supportsassembly development and review of new researchprojects.
- Assist protocolstaff submit initial applications amendments continuing reviewsAdverse Events Serious Adverse Events protocol deviations andSafety 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.
- Manage participants study progress in thetracking system.
Organizesand performs clinical research utilizing internet and otheravailable clinical 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.
- Updateannual status of recruitment/enrolment in NIH Human SubjectsReporting System.
Providesassistance to staff in the collection development and qualitycontrol of essential clinical research efforts.
- Participate in coordination andmanagement of most daily activities of the study and ensure thatstudy activities follow established protocol Standard OperatingProcedures (SOP) and utilizes approved forms templates andpractices.
- Schedule and participate inmonitoring and auditing activities and coordinate responses toaudits.
Supports clinicalstaff develop implement and maintain clinical research data filesand materials.
- Prepareand submit for review accurate source documents related to allresearch procedures.
Develops and facilitates training to new researchcoordinators and mentors researchers in Good ClinicalPractices.
- Organizeprepare and distribute informational materials and provide supportto the educational mission of the study.
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