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DUKE UNIVERSITY HEALTH SYSTEM
POSITION TITLE: Clinical Research Coordinator
JOB CODE: 5026
REPORTS TO: Associate Director, Clinical Research Operations
ACCOUNTABLE TO: Director, Clinical Research
To ensure the protection and safety of research subjects enrolled on clinical trials at the Duke Cancer Network, this individual will 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 may require travel to affiliate community locations.
Duties and Responsibilities of this Level
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 shipmen; 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.
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.
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
Assist with the implementation, coordination, and tracking of research education projects.
Perform other related duties incidental to the work described herein.
Knowledge, Skills, and Abilities:
Clinical Research Management
Required Qualifications at this Level
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.
None required beyond that described above.
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Degrees, Licensure, and/or Certification
Knowledge, Skills, and Abilities
Distinguishing Characteristics of this Level
Job Code: 00005026 CLINICAL RESEARCH COORDINATOR Job Level: F1
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Essential Physical Job Functions: Certain jobsat 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.
As a world-class academic and health care system, Duke Health strives to transform medicine and health locally and globally through innovative scientific research, rapid translation of breakthrough discoveries, educating future clinical and scientific leaders, advocating and practicing evidence-based medicine to improve community health, and leading efforts to eliminate health inequalities.