Durham, North Carolina

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Operations:
Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessaryand alerts appropriate parties. Knowledgeable in regulatory and institutionalpolicies and processes;  applies appropriately in study documentation, protocol submissions, and SOPs. May trainothers in these policies and proces ses. Is responsible for all aspects ofmanaging and documenting Investiga tional Product (IP); including arrival,storage, tracking, and provision to research participants. Serves as the primaryliaison with sponsors, ID S, and other parties as necessary. Follows protocolschema for randomizat ion and blinding/unblinding. May train others. Providesdirection to mult iple study teams/research program to prepare for studymonitoring and aud it visits. Maintains participant level documentation for allstudies, inc luding those that are complex in nature (e.g., procedural andinterventio nal studies) and/or require access to the Duke EHR. May train oroversee others. Employs strategies to maintain retention rates. Evaluates processes to identify problems with retention. May train or oversee others. For multiple study teams, develops and oversees the implementation of strate giesfor meeting recruitment goals.Provides training. Screens participan ts for all studies,including those that are complex in nature (e.g., pro cedural and interventionalstudies). Provides oversight and training in s creening activities to multiplestudy teams. Develops or helps develop SO Ps. May train or oversee others.Collects, prepares, processes, ships, an d maintains the inventory of researchspecimens, primarily those requirin g complex procedures. May train or overseeothers. Maintains study level documentation for all studies, including thosethat are complex in nature (e.g., procedural and interventional studies).Provides oversight and tr aining and lends expertise to multiple study teams.Schedules participant s for research visits. Prepares necessary documents,equipment, supplies, etc. Conducts and documents non-complex visits andscripted testing or i nterviews.  May manage participant payment. Leads meetings that are multidisciplinary,including those with complex objectives.

Ethics:
Identifies all AEs, and determines whether or no t they are reportable.  Collaborates with the PI to determi ne AEattributes, including relatedness to study. May train or oversee ot hers.Conducts and documents consent for participants for all types of st udies,including those thatare complex in nature and/or require any orde rs in MaestroCare. May train or oversee others. Develops consent plans a nd documents forparticipants in a variety of studies. May train or overs ee others. Develops andsubmits documentation and information for IRB rev iew. Communicates with the IRBstaff and reviewers and handles issues app ropriately. May train or overseeothers. Prepares and submits documents n eeded for regulatory and safetyreporting to sponsors and other agencies. May train or oversee others.

Data:
Enters and coll ects data.  Develops dataentry or collection SOPs or tools. May provide oversight or training to studyteam members collecting or en tering data. Independently corrects and documentsincomplete, inaccurate or missing data for non-complex studies. Follows SOPsfor quality assurance. Runs summaries and reports on existing data. Followsrequired process es, policies, and systems to ensure data security andprovenance. Learns and uses new technology when required.

Science:
May assist with simple literature searches under supervision from PI or CRC .Under guidance, develops sections of protocols for simple studies (e.g. ,registries, survey studies). Demonstrates a basic understanding of the elementsof research study designs.

Study and Site Management:
Prepares for, coordinates, and actively participates in site visits.Communicates effectively with sponsors and/or CROs. Records parti cipant accrualinformation and consent documentation for non-complex stud ies in clinicalresearch management system. Records basic protocol inform ation in clinicalresearch management system. Collects appropriate inform ation to determinewhether the study team's participation in a specific trial is feasible. Maymake recommendations. For studies with simple suppl ies or equipment, ensuresthat there are ample supplies and that equipmen t is in good working order.Ensures that studies are conducted in compliance with institutionalrequirements and other policies. Follows protocol- specific systems and processflows. Prepares studies for closeout and doc ument storage. May train or overseeothers.

Leadership:Navigates processes and people involved in Duke clinical research, d emonstratesthe organizational awareness, and has the interpersonal skills necessary  to get work done efficiently. Demonstrates resilience and is adaptive to change. Communicates effectively with others,r egardless of reporting relationship, to accomplish shared work objectives.



Type of Research:
The position invo lves research in the pediatric population. Pediatric Nephrology conducts trials from phase 1-IV. Trials can be industry, grant, and investigator initiated.  CRC will assist in operationalizing the trials. Trials may be complex in nature.

Special skill s:
Experience in Human Subject Research with emphasis on Phase 1 thru 4 trials preferred.  Good organization andcommunication skills.  Knowledgeable indata base navigation and regulatory compliance for clinical trials

 

Minimum Qualifications

 

Education

Completion of an Associate's degree

 

Experience

 

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.

 

Durham, North Carolina

As a world-class academic and health care system, Duke Health strives to transform medicine and health locally and globally through innovative scientific research, rapid translation of breakthrough discoveries, educating future clinical and scientific leaders, advocating and practicing evidence-based medicine to improve community health, and leading efforts to eliminate health inequalities.

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