CLINICAL RESEARCH ASSOCIATE I

School of Medicine:

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Occupational Summary

Develop, coordinate, and implement monitoring strategies essential to the successful management of clinical trials conducted by Principal Investigators (PIs) at the Duke Cancer Institute (DCI). 

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 rules and regulations.

Responsibilities and Expectations

Conduct Monitoring visits

Assess study status and accrual using available databases and systems to identify protocols requiring monitoring and safety oversight and to ensure all subjects signing consent are registered in all systems.  System examples are eIRB, eResearch, iRIS, OnCore, and Epic.  Review study files, paper and electronic CRFs, and data collection tools for accuracy, legibility and consistency.  Verify data entries with source.

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

Assist in the conduct of internal and external, clinical and regulatory monitoring such as pre-study, site initiation, close-out, and Investigational Drug Accountability both requested and routinely scheduled.  Schedule and coordinate monitoring visits.

Prepare for monitoring visits.  Review protocol and research documents.  Review electronic databases for regulatory and toxicity documentation and subject registration.  Prepare appropriate monitoring documents.  Provide feedback and education to study teams to facilitate successful protocol management.

Advocate the protection and safety of subjects. 

Contribute to the ongoing development and improvement of forms, tools, templates and processes. 

Preparation for SOC Review and follow-up

Assist in Safety Oversight Committee (SOC) meeting preparation and contribute to the SOC meeting agendas and discussions.

Complete monitoring reports.  Identify site deficiencies and provide assistance with developing, implementing and evaluating Corrective and Preventive Action Plans (CAPAs).  Review PI and study team responses to monitoring reports to ensure a satisfactory plan has been developed and communicated.

Communication 

Collaborate, and communicate with other study personnel as required.  Communicate concerns clearly in a professional manner.  Respond timely to emails, phone calls and questions.  Refer more complex questions and escalate issues to others as appropriate.  

Leadership

Actively network.  Provide leadership within the team.  Actively and proactively participate in team meetings, committees, task forces and ad hoc groups. 

Encourage career development by actively seeking out continuing education opportunities.  Participate in scientific presentations and publications. 

Serve as an expert resource for colleagues and teammates.  Mentor staff, including those in the same job title.  Support colleagues in their project work; encourage completion. 

Ethics 

Know and follow policies, standard operating procedures [SOPs], regulations and protocol requirements that govern clinical research.  Maintain Duke and department specific training and certification requirements.

And other work as assigned. 

Skills

Excellent written, oral and conversational communication skills to effectively work with diverse groups.

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. 

Preferences

Completion of a bachelor's degree in health field plus a minimum of one year directly related experience in clinical trials research or oncology.  CCRP or ACRP certification. 

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.**

None required beyond that described above. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

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.