Clinical Research Coordinator - Duke Cancer Network

Employer
Duke University
Location
DCN CLINICAL ADMINISTRATION

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Job Details

Duke Nursing Highlights:

  • Duke University Health System is designated as a Magnet® organization
  • Nurses from each hospital are consistently recognized each year as North Carolina’s Great 100 Nurses.
  • Duke University Health System was awarded the American Board of Nursing Specialties Award for Nursing Certification Advocacy for being strong advocates of specialty nursing certification.
  • Duke University Health System has 6000 + registered nurses
  • Quality of Life: Living in the Triangle!
  • Relocation Assistance!

DUKE UNIVERSITY HEALTH SYSTEM

Clinical Research Coordinator

JOB CODE: 5026

REPORTS TO: Associate Director, Clinical Research Operations

ACCOUNTABLE TO: Director, Clinical Research

Position Summary

Participate in the day-to-day operations of oncology clinical research studies conducted by the principal investigator(s) at Duke University Health System research affiliate community locations. Perform a variety of duties to support the conduct of clinical research such as collection, compilation, documentation, and analysis of clinical research data to ensure adherence to protocols and validation of information received. Knowledgeable of clinical research regulatory requirements, institutional policies and processes, and good clinical practices. This position will be funded primarily by multi-year clinical research grants, and cooperative group and industry clinical trials. This position may require travel to affiliate community locations.

Duties and Responsibilities of this Level

Data Management:

Maintain participant level and study level documentation for all clinical research, including those that are complex in nature and/or require access to electronic health records (EHR). Coordinate and implement procedures to collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources; code, evaluate and interpret collected data and prepare appropriate documentation. Complete paper and electronic Case Report Forms (CRFs and eCRFs) accurately and according to protocol. Use required processes, policies, and systems to ensure data security and confidentiality. Assist in investigating incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data. Generate reports and reviews to ensure the validity of data; May develop processes and oversee the creation and use of queries, summaries, and reports for quality assurance purposes. May be responsible for recognizing trends related to data quality and escalating as appropriate.

Assist with the development of source documentation templates, questionnaires, electronic case report forms, and procedures for data collection and reporting. Participate in quality assurance reviews, audits, and monitoring visits. Communicate regularly with monitors as needed to provide information before and after visits; review reports and follow up on issues identified and implement corrective actions as appropriate.

Clinical Operations:
Assist in identifying participants that meet eligibility requirements for clinical trials under the supervision of the clinical operations team. Provide operational support for the daily coordination of clinical trials, which may include but is not limited to, maintaining communications with sites to provide information, track documentation and overall progress of clinical trials and adherence to established guidelines; ensure that study materials and kits are shipped and re-supplied as requested; respond to routine questions related to study protocol and refer more complex questions to others as appropriate.

Regulatory:

Assure compliance of general and study-specific regulatory-related processes with SOPs, FDA, NIH, and applicable regulations for the reporting of events to regulatory agencies. Develop appropriate regulatory reports and associated documentation per SOPs and study-specific processes

Education:

Assist with the implementation, coordination, and tracking of research education projects.

Perform other related duties incidental to the work described herein.

Required Qualifications at this Level

Education

Work requires graduation from an accredited degree program in a clinical field such as a BSN, Physician's Assistant (PA) or Pharmacist plus two years of healthcare experience, or one of the following equivalents:

1. 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 five years healthcare, clinical and/or research experience; or

2. Completion of a bachelor's degree in a field related to health science plus a minimum of three years closely related clinical and/or research experience.

Experience

None required beyond that described above.

OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Degrees, Licensure, Certification

N/A

Knowledge, Skills, and Abilites SUPERVISION

ANALYZE TRENDS

INTERVIEWING SKILLS

STATISTICAL ANALYSIS

DATA ANALYSIS

Distinguishing Characteristics of this LevelN/A

Job Code: 00005026 CLINICAL RESEARCH COORDINATOR
Job Level: F1

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 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.

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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