CLINICAL RESEARCH ASSOCIATE I
DCI OFFICE OF RESEARCH SUPPORT

OCCUPATIONAL SUMMARY
Develop, coordinate,and implement monitoring strategies essential to
the successful management
of Oncology clinical trials conducted by Principal Investigators (PIs)
at the Duke Cancer Institute
(DCI).
OCCUPATIONAL OBJECTIVES
Ensure the protection and safety of research subjects.
Educate PIs and research professionals on the conduct of oncology
clinical trials.
Ensure the quality and integrity of data with respect to accuracy,
accountability, documentation,
and adherence to procedures through review of case report forms (CRFs),
source documents,
medical records, and regulatory documents.
Ensure studies are conducted in accordance with the protocol, Standard
Operating Procedures
(SOPs), Good Clinical Practice (GCP), and applicable regulations.
RESPONSIBILITIES AND
EXPECTATIONS
Assess study status and accrual using available databases and systems
e.g. eIRB, eResearch,
iRIS, OnCore, Epic to identify protocols requiring monitoring and
safety oversight and to ensure all
subjects signing consent are registered in eResearch, Oncore or Epic.
Maintain up-to-date
electronic
and paper monitoring management
systems.
Schedule and coordinate monitoring visits.
Prepare for monitoring visits. Review protocol/research documents;
Review electronic databases
for regulatory and toxicity documentation and subject registration;
Prepare appropriate monitoring
documents.
Assist in the conduct of internal and external, clinical and regulatory
monitoring: Pre-study; Site
Initiation; Routine; Close-out; Requested; Investigational Drug
Accountability.
Review study files, paper/electronic CRFs, and data collection tools
for accuracy, legibility and
consistency. Verify data entries with source.
Advocate the protection and safety of subjects.
Assist in Safety Oversight Committee (SOC) meeting preparation and
contributes to SOC meeting
discussion.
Provide feedback and education to study teams to facilitate successful
protocol management.
Complete monitoring reports. Review PI and study team response to
monitoring reports to ensure
a satisfactory response or plan.
Identify site deficiencies and provide assistance with developing,
implementing and evaluating
Corrective and Preventive Action Plans (CAPAs).
Contribute to the ongoing development and improvement of forms, tools,
templates and
processes.
Skills
1.tExcellent written, oral and conversational communication skills to
effectively work
with diverse groups.
2.tAbility to analyze,evaluate multiple solutions and solve complex
problems using well
developed critical & analytical thinking skills.
3.tExcellent time management skills needed to prioritize among many
competing
priorities.
4.tAttention to detail needed to operate accurately and effectively in
the regulatory
environment.
5.tMastery of Microsoft Office.
And other work as assigned.

Requisition Number
401492675

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1392 CLINICAL RESEARCH ASSOCIATE I

Job Family Level
79

Exempt/Non-Exempt
Exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications
Duke University 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 essential job 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.


Education

Work requires graduation from an accredited degree program providing
clinical training as a Registered Nurse (RN), Physician's Assistant
(PA) or Pharmacist plus one year of healthcare experience; or one of
the following equivalents:

Completion of an allied health degree (e.g., Respiratory Therapy,
Radiologic Technology, Licensed Practical Nurse) or Associates degree in
Clinical Trials Research related curriculum plus a minimum of
three years healthcare experience; or

Completion of a master's degree in Public Health, Health
Administration or a related area with no additional experience; or

Completion of a bachelor's degree plus a minimum of one year directly
related experience in clinical trials research; or

Completion of a bachelor's degree plus a minimum of two years closely
related research experience.

**State of North Carolina license may be required.**


Experience

None required beyond that described above.

OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Auto req ID

104989BR

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

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job 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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