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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

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