Job description

School of Medicine:

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Recognizes when typical agr eements (MTAs, CDAs, DUAs, DTAs, etc.) are necessaryand alerts appropria te parties. Knowledgeable in regulatory and institutionalpolicies and pr ocesses; applies appropriately in study documentation, protocolsubmissio ns, and SOPs. May train others in these policies and processes.Assists w ith study level documentation and approvals for international studies.Is responsible for all aspects of managing and documenting Investigational Product (IP); including arrival, storage, tracking, and provision to res earchparticipants. Serves as the primary liaison with sponsors, IDS, and otherparties as necessary. Follows protocol schema for randomization an dblinding/unblinding. Prepares for and provides support for study monito ring andaudit visits, including support for the reviewer. Addresses and correctsfindings. Maintains participant level documentation for all stud ies, includingthose that are complex in nature (e.g., procedural and interventional studies)and/or require access to the Duke EHR. Employs strat egies to maintain retentionrates. Evaluates processes to identify proble ms with retention. Employs and maydevelop strategies to maintain recruit ment rates and evaluate processes toidentify problems. Escalates issues internally as appropriate. Screensparticipants for all studies, includin g those that are complex in nature (e.g.,procedural and interventional s tudies). Provides oversight and training inscreening activities to multiple study teams. Develops or helps develop SOPs.Collects, prepares, proc esses, ships, and maintains the inventory of researchspecimens, primaril y those requiring complex procedures. Maintains study leveldocumentation for all studies, including those that are complex in nature(e.g., proce dural and interventional studies). Provides oversight and trainingand le nds expertise to multiple study teams. Conducts and plans for complexstu dy visits. Participates in study team meetings and provide regular updatesto team, PI and manager. May train or oversee others.

Identifies all AEs, and determines whether or not they are reportab le.Collaborates with the PI to determine AE attributes, including relate dness tostudy. Conducts and documents consent for participants for all t ypes ofstudies, including those that are complex in nature and/or requir e any ordersin Maestro Care. Develops consent plans and documents for pa rticipants in avariety of studies. May train or oversee others. Develops and submitsdocumentation and information for IRB review. Communicates w ith the IRB staffand reviewers and handles issues appropriately. Prepare s and submits documentsneeded for regulatory and safety reporting to spo nsors and other agencies.

Enters and collects data. Develops data entry or collection SOPs or tools. Mayprovide oversight or training to study team members collecting or enteringdata. Ensures accu racy and completeness of data for all studies, includingthose that are c omplex in nature.Recognizes data quality trends and escalatesas appropr iate. May develop tools for, and train others in, data qualityassurance procedures. Recognizes and reports security of physical andelectronic da ta vulnerabilities. May develop or review RDSPs for multiple studyprotoc ols. Maps a protocol's data flow plan including data capture, storage,tr ansfer, management, quality, and preparation for analysis (may include d atafrom EDCs, EHR, mobile apps, etc.). May train or oversee others. Lear ns anduses new technology when required.

Assists with or contributes to the development of funding proposals. Underguidan ce, develops sections of protocols for simple studies (e.g., registries, survey studies). Demonstrates a basic understanding of the elements of r esearchstudy designs. Provides some contribution to scientific publicati ons orpresentations (noauthorship).

Study and Site Management :
Prepares for, coordinates, and actively participates in site visit s.Communicates effectively with sponsors and/or CROs. Uses clinical rese archmanagement system and its reports to manage research participants' a ctivities,calendars, tracking/marking financial milestones, and all aspe cts of studyvisits. Uses required EMR functionalities to manage particip ants and studyvisits. Uses clinical research management system and its r eports to manage allprotocol activities, including minimum footprint, SI P counsel, and all aspectsof maintaining current protocol information. C ollects appropriate informationto determine whether the study team's par ticipation in a specific trial is feasible.May make recommendations in p rocess improvement or workflows. For studies withcomplex supplies or equ ipment, ensures thatthere are ample supplies and thatequipment is in go od working order. May forecast staffing needs. Ensures thatstudies are c onducted in compliance with institutional requirements and otherpolicies . Follows, and may develop or implement, protocol-specific systems anddo cuments including process flows. Prepares studies for closeout and docum entstorage per protocol and institutional requirements. May train or ove rseeothers.

Proactively seeks opportunities to add relevant skills and certifications toown portfolio. Keeps current w ith research updates by attending key externalofferings (i.e. Research W ednesday, RPN, events outside of Duke, etc.) andapplies the learned mate rial to the job. May disseminate information to others.Serves on committ ees and workgroups internal to Duke or externally intherapeutic area of research. Demonstrates interpersonal skills toget workdoneefficiently. Recognizes and escalates organizational issues that could beoptimized t o improve research process. Demonstrates resilience and is adaptiveto ch ange. Uses advanced subject matter expertise in the therapeutic area orc linical research to solve problems. Communicates effectively with others ,regardless of reporting relationship, to accomplish shared work objecti ves.

Research Activities: (Effort 60%)

·Provided c linical research nurse coordination and implementation forassigned pedia tric neurology clinical research projects


Consent patients to assigned studie s including but notlimited tointerventional, observational and retrospe ctive research

·Coordinate all clinical visits in multiple settings

·Perform nursing assessments during research visits as defined perprotocol

·Complete SOM and S ponsor electronic study management systems, includingbut not limited to iRIS, OnCore, MaestroCare

·Collect and review clinical data as needed per prot ocol and enter intoappropriateCRF/eCRF

·Conduct initial study eligibility scr eening; review with PI

· span>Collect and process research samples including biologi cs

·La boratory processing and shipping of research samples

·Participate in team mee tings, providing updates to PI and team

< p>Regulatory Support: (Effort 20%)

·Prepare regulatory submissions throu gh approval for multiple studies andmaintain regulatory files through th e life-cycle of the study

·Participate in monitoring visits, resolving all iss ues identified by thesponsor or its representative





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Job No:
Posted: 12/29/2020
Application Due: 3/29/2021
Work Type: Full Time