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LAB RESEARCH ANALYST I
Requisition Number:: 173922
Date: Jan 24, 2022
Durham, NC, US, 27710
Personnel Area: MEDICAL CENTER
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
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.
Department of Neurosurgery, Duke School of Medicine
A Lab Research Analyst 1 position is available in the Department of
Neurosurgery at Duke University. We are seeking motivated individuals to lead,
coordinate, and perform a variety of complex independent and team activities
involved in the planning, collection, analysis, documentation and
interpretation of social, economic, clinical and health-related research
information and data. The successful candidate will work in a collaborative
environment directly with the Director of Spine Oncology and in conjunction
with students, residents, fellows, faculty and other scientists in the
Departments of Neurosurgery, Orthopaedic Surgery, Radiation Oncology,
Medicine, Anesthesiology, Radiology, Pharmacology and Cancer Biology, and the
Duke Center for Brain and Spine Metastasis. This position will lead the
clinical and translational research efforts focused on the identification of
demographic, clinical and molecular determinants associated with optimal
paradigms and therapies for patients diagnosed with neurosurgical pathologies,
and primarily spine oncology.
The position will also aid the overall research program spanning from the
bench to bedside with a multidisciplinary team. Key features of this role
(1) coordination, growth and development of the program's clinical and
translational research portfolio,
(2) oversight and management of retrospective and prospective clinical
(3) oversight of clinically-annotated banked tissues from patient samples
treated at Duke for brain and spine metastases.
(4) grant writing assistance for local, federal and/or foundation grants
pertinent to the program, (5) oversight and management of clinical research
protocols, data, and regulatory support, (6) screening, consenting,
recruitment, and enrollment of neurosurgical patients into pertinent clinical
studies, (7) mentorship, and training of students conducting research, (8)
oversight of clinically-annotated banked tissues from patient samples treated
at Duke for brain and spine metastases, and (9) support for basic science
initiatives related to clinical and translational research studies.
DUTIES AND RESPONSIBILITIES INCLUDE:
Basic/Translational Science (40%):
• Leads, assists or contributes to the development of research protocols,
literature reviews, statistical analysis plans, abstracts, and manuscripts
drafts (including reference management and submission of materials)
independently and in collaboration with trainees, faculty, and collaborators.
• Perform standard technical procedures such as PCR, qPCR, and
electrophoresis, DNA extraction from human clinical specimens, fresh-frozen
and/or paraffin-embedded tissue and aid in execution of experimental design
and analysis of next generation sequencing data.
• Organize and perform integrative analysis of complex genetic and morphologic
• Assists in the perform vivo experiments of metastasis using subcutaneous,
tail vein injection, intracardiac, and other orthotopic animal models in
conjunction with existing personnel.
• Conducts and documents consent for participants and collects and enters
study data via data platform for all studies.
• Develops data entry or collection Standard Operating Procedures
(SOPs)/tools for clinical specimens and sequencing.
• May provide oversight or training to study team members collecting or
• Involved in training and education of neurosurgery residents, medical and
graduate students in the School of Medicine, and undergraduates under the
leadership of the Director of Spine Oncology. Directs trainees in the
appropriately conducting research studies and provides supportive oversight
for all clinical studies.
• May serve as an alternate for the Director of Spine Oncology on committees
and workgroups internal to Duke or externally in research areas of interest.
Clinical Research (30%):
• Leads, assists or contributes to the development of letters of intent,
budgets, funding proposals, literature searches.
• Assist statisticians with computational and/or statistical analysis.
• Demonstrates and teaches elements of research study designs.
• Contributes to the development of scientific publications or presentations
and serves as an author on publications and as an alternate presenter on
poster and oral presentations.
• Prepares for and provides support for study monitoring and audit visits,
including support for the reviewer.
• Screens participants for all studies, including those that are complex in
nature (e.g., procedural, and interventional studies). Provides oversight
and training in screening activities to multiple study teams.
• Leads team meetings and facilitates healthy communication between staff.
Ensures good communication across multiple study teams, and mentors' staff to
improve communication strategies.
• Responsible for all aspects of Investigational Products (IP), study level
documentation for studies, maintains study level documentation for all
studies, (e.g., procedural, and interventional studies) and leads and
conducts study visits.
• Knowledgeable in regulatory and institutional policies and processes;
applies appropriately in study documentation, protocol submissions, and SOPs.
• Ensures accuracy and completeness of data for all studies, and recognizes
data quality trends, escalating as appropriate.
• Recommends, assists and leads implementation of improved strategies,
processes, policies, and systems to ensure data security and data provenance.
• Maps a protocol's data flow plan including data capture, storage, transfer,
management, quality, and preparation for analysis (includes data from
Electronic Data Capture systems, Electronic Medical Record (EMR), mobile
• Recognizes, develops and drafts SOPs and agreements (Material Transfer
Agreements (MTA), Confidential Disclosure Agreement (CDA), Data Use
Agreement (DUA), Data Transfer Agreement (DTA), etc.).
• Maintains participant level documentation for all studies, including those
that are complex in nature (e.g., procedural, and interventional studies)
and/or require access to the Duke Medical Record.
• Serves as the primary liaison with sponsors, IDS, Food and Drug
Administration (FDA) regulatory submissions in collaboration with other
offices for the development, submission, and maintenance of relevant
• Collects, prepares, processes, ships, and maintains the inventory of
Study Oversight and Ethics (5%):
• Identifies Adverse Events and determines, with PI oversight, per specific
protocol whether or not they are reportable. Collaborates with the PI to
determine adverse events attributes, including relatedness to study.
• Create, submit and coordinate protocol required orders, i.e. Smartset orders
in Maestro Care.
• Develops and submits documentation and information for IRB review,
regulatory and safety reporting to sponsors and communicates with relevant
staff, agencies sponsors, CROs and reviewers.
• Uses required EMR functionalities to manage participants and study visits.
Includes scheduling of patients enrolled in clinical studies in conjunction
with the patient navigators and staff assistants to maintain study endpoints.
• Works with the CRU to ensure that studies within the research program are
conducted in compliance with institutional requirements and policies, which
may include Clinical Quality Management Plan (CQMP)reviews for selected
• Prepares studies for closeout and document storage. May train or oversee
• Oversee possible use of clinical research management system and its reports
to manage research participants' activities, calendars, tracking/marking
financial milestones, and all aspects of study visits.
• Proactively seeks opportunities to add relevant skills and certifications to
own portfolio and uses subject matter expertise to solve complex problems or
foster innovation within the research program.
• Keeps current with research updates by attending relevant conferences,
seminars, symposium, and other external offerings and applies the learned
material to the job.
• Demonstrates interpersonal skills, communications, resilience, and
leadership to promote efficiency, lead and assign activities to other research
team members to accomplish shared work objectives.
• Liaison with Duke other programs to coordinate clinical research business
and to accomplish program objectives.
• May train or oversee others in the above activities and processes or perform
other related duties.
The ideal candidate will have prior experience as a clinical research
coordinator, preferably in neurosciences/ neurosurgery/orthopaedic surgery,
with patient interaction experience, including developing, editing, and
submitting study applications to the Institutional Review Board for review,
consent process, study documentation, study regulatory maintenance, as well as
effectively implementing study protocols independently. Proficiency in Word,
Excel, Microsoft Teams, Power Point, and general technical skills is desired.
Professional level writing skills is required and a writing sample/test will
be performed. This candidate should possess a basic background in
scientific/medical concepts, have exceptional organizational and time
management skills, be adaptive to change, and possess excellent communication
and problem-solving skills. The ideal candidate will have strong relationship
building skills, which promote cooperative, collaborative, and creative
partnerships within a diverse team.
Work requires two years of research experience. A related master's or an
equivalent combination of relevant education and/or experience/degree may
offset required years of experience on a 1:1 basis, e.g., a two-year master's
degree in lieu of two years of experience. The position entails a one- to
three-year period, with extension contingent on perfor
Knowledge, Skills and Abilities
Work requires a bachelor's degree in botany, biology, zoology, psychology or
other directly related scientific field.
Work requires two years of research experience. A related master's OR AN
EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE degree may
offset required years of experience on a 1:1 basis, e.g., a two year master's
degree in lieu of two years of 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
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
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