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CLINICAL RESEARCH ASSOCIATE I

Employer
Duke University
Location
Durham, NC

View more

Administrative Jobs
Academic Affairs, Research Staff & Technicians
Employment Type
Full Time
Institution Type
Four-Year Institution

Job Details


diversity employer



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.

Maintain up-to-date electronic and paper monitoring management systems.

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.

And other work as assigned.

The above statements describe the general nature and level of work being performed. This is not intended to be an exhaustive list of all responsibilities and duties required. Employees may be directed to perform job-related tasks other than those specifically presented in this description.

The intent of this job description is to be representative of the level and the types of duties and responsibilities that will be required of this position and shall not be construed as a declaration of the total specific duties and responsibilities.

Requisition Number
401545903

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1392 CLINICAL RESEARCH ASSOCIATE I

Job Family Level
79

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

Skills
  1. Excellent written, oral and conversational communication skills to effectively work with diverse groups.
  2. Ability to analyze, evaluate multiple solutions and solve complex problems using well developed critical & analytical thinking skills.
  3. Excellent time management skills needed to prioritize among many competing priorities.
  4. Attention to detail needed to operate accurately and effectively in the regulatory environment.
  5. Mastery of Microsoft Office.


Auto req ID

108949BR

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.

PI107086419

Organization

Read our Diversity Profile History

Duke University was created in 1924 by James Buchanan Duke as a memorial to his father, Washington Duke. The Dukes, a Durham family that built a worldwide financial empire in the manufacture of tobacco products and developed electricity production in the Carolinas, long had been interested in Trinity College. Trinity traced its roots to 1838 in nearby Randolph County when local Methodist and Quaker communities opened Union Institute. The school, then named Trinity College, moved to Durham in 1892, where Benjamin Newton Duke served as a primary benefactor and link with the Duke family until his death in 1929. In December 1924, the provisions of indenture by Benjamin’s brother, James B. Duke, created the family philanthropic foundation, The Duke Endowment, which provided for the expansion of Trinity College into Duke University.Duke Campus

As a result of the Duke gift, Trinity underwent both physical and academic expansion. The original Durham campus became known as East Campus when it was rebuilt in stately Georgian architecture. West Campus, Gothic in style and dominated by the soaring 210-foot tower of Duke Chapel, opened in 1930. East Campus served as home of the Woman's College of Duke University until 1972, when the men's and women's undergraduate colleges merged. Both men and women undergraduates now enroll in either the Trinity College of Arts & Sciences or the Pratt School of Engineering. In 1995, East Campus became the home for all first-year students.

Duke maintains a historic affiliation with the United Methodist Church.

Home of the Blue Devils, Duke University has about 13,000 undergraduate and graduate students and a world-class faculty helping to expand the frontiers of knowledge. The university has a strong commitment to applying knowledge in service to society, both near its North Carolina campus and around the world.

Mission Statement

Duke Science"James B. Duke's founding Indenture of Duke University directed the members of the University to 'provide real leadership in the educational world' by choosing individuals of 'outstanding character, ability, and vision' to serve as its officers, trustees and faculty; by carefully selecting students of 'character, determination and application;' and by pursuing those areas of teaching and scholarship that would 'most help to develop our resources, increase our wisdom, and promote human happiness.'

“To these ends, the mission of Duke University is to provide a superior liberal education to undergraduate students, attending not only to their intellectual growth but also to their development as adults committed to high ethical standards and full participation as leaders in their communities; to prepare future members of the learned professions for lives of skilled and ethical service by providing excellent graduate and professional education; to advance the frontiers of knowledge and contribute boldly to the international community of scholarship; to promote an intellectual environment built on a commitment to free and open inquiry; to help those who suffer, cure disease, and promote health, through sophisticated medical research and thoughtful patient care; to provide wide ranging educational opportunities, on and beyond our campuses, for traditional students, active professionals and life-long learners using the power of information technologies; and to promote a deep appreciation for the range of human difference and potential, a sense of the obligations and rewards of citizenship, and a commitment to learning, freedom and truth.Duke Meeting

 “By pursuing these objectives with vision and integrity, Duke University seeks to engage the mind, elevate the spirit, and stimulate the best effort of all who are associated with the University; to contribute in diverse ways to the local community, the state, the nation and the world; and to attain and maintain a place of real leadership in all that we do.”

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