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 agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessaryand alerts appropriate part ies. Prepares FDA regulatory submissions incollaboration with ORAQ, incl uding development, submission, and maintenance ofrelevant documentation. Addresses FDA review and/or potential hold issues incollaboration with the Principal Investigator (PI). May train or overseeothers. Knowledgeab le in regulatory and institutional policies andprocesses; applies appropriately instudy documentation, protocol submissions, and S OPs. May train others in thesepolicies and processes. Maintains study le vel documentation for internationalstudies. May develop resources and to ols for management of internationalstudies, and/or coordinate with other entities or offices. Is responsible forall aspects of managing and docu menting Investigational Product (IP); includingarrival, storage, trackin g, and provision to research participants. Serves asthe primary liaison with sponsors, IDS, and other parties as necessary. Followsprotocol sche ma for randomization and blinding/unblinding. May train others.Prepares for and provides support for study monitoring and audit visits,including support for the reviewer. Addresses and corrects findings. May trainoth ers. Maintains participant level documentation for all studies, includin gthose that are complex in nature (e.g., procedural and interventional s tudies)and/or require access to the Duke EHR. May train or oversee other s.Employsstrategies to maintain retention rates. Evaluates processes to identifyproblems with retention. May train or oversee others. Employs a nd may developstrategies to maintain recruitment rates and evaluate proc esses to identifyproblems. Escalates issues. May train or oversee others . Screens participantsfor all studies, including those that are complex in nature (e.g., proceduraland interventional studies). Provides oversig ht and training in screeningactivities to multiple study teams. Develops or helps develop SOPs. May trainor oversee others. Collects, prepares, processes, ships, and maintains theinventory of research specimens, prim arily those requiring complex procedures.May train or oversee others. Ma intains study level documentation for allstudies, including those that a re complex in nature (e.g., procedural andinterventional studies). Provi des oversight and training and lends expertise tomultiple study teams. C onducts and plans for complex study visits. May trainstaff. Leads meetin gs that are multidisciplinary, including those with complexobjectives. < br/>
Identifies all AEs, and determines whether or not t hey are reportable.Collaborates with the PI to determine AEattributes, including relatedness to study. May train or oversee other s.Conducts and documents consent for participants for all types of studi es,including those that are complex in nature and/or require any orders in MaestroCare. May train or oversee others. Develops consent plans and documents forparticipants in a variety of studies. May train or oversee others. Develops andsubmits documentation and information for IRB review . Communicates with the IRBstaff and reviewers and handles issues approp riately. May train or overseeothers. Prepares and submits documents need ed for regulatory and safety reportingto sponsors and other agencies. Ma y train or oversee others.

Enters and collects data. Develops dataentry or collection SOPs or tools. May provi de oversight or training to studyteam members collecting or entering dat a. Ensures accuracy and completeness ofdata for all studies, including t hose that are complex in nature. Recognizesdata quality trends and escal ates as appropriate. May develop tools for, andtrain others in, data qua lity assurance procedures. Recognizes and reportssecurity of physical an d electronic data vulnerabilities. May develop or reviewRDSPs for multip le study protocols. Maps a protocol's data flow plan includingdata captu re, storage, transfer, management, quality, and preparation foranalysis (may include data from EDCs, EHR, mobile apps, etc.). May train oroverse e others. Independently uses and implements technology to enhanceproduct ivity or process. May train or oversee others.

As sists withor contributes to the development of funding proposals. Assis tswith simple literature searches. Using scientific proposals from the P I,develops research protocols. Demonstrates a basic understanding of the elementsof research study designs. Contributes to the development of sc ientificpublications or presentations.Serves asan author on poster presentations or publications.

Study and Site Manage ment:
Prepares for, coordinates, and actively participates in site v isits.Communicates effectively with sponsors and/or CROs. Uses clinical researchmanagement system and its reports to manage research participant s' activities,calendars, tracking/marking financial milestones, and all aspects of studyvisits. Uses required EMR functionalities to manage part icipants and studyvisits.May train others. Uses clinicalr esearch management system and its reports to manage all protocol activit ies,including minimum footprint, SIP counsel,and all aspects of maintai ningcurrent protocol information. May train others. Collects appropriate information to determine whether the study team's participation in a spe cifictrial is feasible. May make recommendations. For studies with compl ex suppliesor equipment, ensures that there are ample supplies and that equipment is ingood working order. May forecast staffing needs. May trai n or oversee others.Ensures that studies are conducted in compliance wit h institutionalrequirements and other policies. Follows, and may develop or implement,protocol-specific systems and documents including process flows. May train oroversee others. Prepares studies for closeout and doc ument storage. May trainor oversee others.

Pro actively seeks opportunities to add relevant skills and certifications t oown portfolio. Keeps current with research updates by attending key ext ernalofferings (i.e. Research Wednesday, RPN, events outside of Duke, et c.) andapplies the learned material to the job. May disseminate informat ion to others.Serves on committees and workgroups internal to Duke or ex ternally intherapeutic area of research. Demonstrates interpersonal skil ls to get workdone efficiently. Recognizes and escalates organizational issues that could beoptimized to improve research process. Demonstrates resilience and is adaptiveto change. Uses advanced subject matter expert ise in the therapeutic area orclinical research to solve problems. Commu nicates effectively with others,regardless of reporting relationship, to accomplish shared work objectives.

Minimum Qualifications


Completion of an Associate's degree


Work requires a minimum of two years of relevant research experience. A Bachelor's degree may substitute for 2 years required experience.

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.




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Job No:
Posted: 2/17/2021
Application Due: 5/18/2021
Work Type: Full Time