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Position Summary

The Duke Cancer Network (DCN) is looking for a research coordinator to assist with the daily management and oversight of multiple complex oncology clinical trials conducted at Duke Community affiliate sites. The ideal candidate should have experience in the implementation, subject recruitment, and management of oncology therapeutic and non-therapeutic clinical trials with a strong understanding of clinical research regulatory requirements, institutional policies and processes, and good clinical practices.

This individual will perform a variety of duties to support the conduct of clinical research such as obtaining informed consent, advising sites on required research activities, and collection, compilation, and documentation of clinical research data to ensure adherence to protocols and validation of information received.

The individual should demonstrate good interpersonal communication skills and business etiquette, flexibility to local travel as needed. This individual should be detailed oriented, organized, and able to multi-task and prioritize work independently. This position is conducted primarily remotely with 10% local travel as needed to manage clinical trials.

JOB RESPONSIBILITIES

The following description of job responsibilities and standards reflects the major duties of the job but does not describe minor duties or other responsibilities that are assigned from time to time.

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. Coordinates the recruitment, enrollment, and management of subjects on clinical trials at DCN clinical sites. This includes working with the treating physician to ensure subject eligibility, facilitating investigational agent procurement and appropriate documentation, and timely/accurate communication with the site regarding study subject needs and requirements. Works with sites to facilitate specimen collection and shipment; 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. Understands study-specific clinical trial billing nuances and works with the DCN research team and affiliate site team to ensure accuracy of patient billing.

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. 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, follow up on issues identified, and implement corrective actions as appropriate.

Regulatory:

Assure research compliance and integrity in alignment with institutional processes and policies, FDA, OHRP, NIH, and applicable regulations and guidelines for managing clinical research. Responsible for regulatory reporting of unanticipated and serious adverse events.

Minimum Qualifications

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.