CLINICAL RESEARCH ASSOCIATE I
CLINICAL RESEARCH ASSOCIATE I
DCI OFFICE OF RESEARCH SUPPORT
Develop, coordinate, and implement monitoring strategies essential to the successful management of Oncology clinical trials conducted by Principal Investigators (PIs) at the Duke Cancer Institute (DCI).
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 regulations.
Responsibilities and Expectations
Assess study status and accrual using available databases/systems e.g. eIRB, eResearch, DOCR to identify protocols requiring monitoring/safety oversight and to ensure all subjects signing consent are registered in eResearch.
Maintain up-to-date electronic and paper monitoring management systems. Assist in the development, implementation and evaluation of an electronic monitoring database.
Schedule and coordinate monitoring visits.
Prepare for monitoring visits. Review protocol/research documents; Review electronic databases for regulatory and toxicity documentation and subject registration; Prepare appropriate monitoring documents.
Assist in the conduct of internal and external, clinical and regulatory monitoring: Pre-study; Site Initiation; Routine; Close-out; Requested; Investigational Drug Accountability.
Review study files, paper/electronic CRFs, and data collection tools for accuracy, legibility and consistency. Verify data entries with source.
Advocate the protection and safety of subjects.
Assist in Safety Oversight Committee (SOC) meeting preparation and contributes to SOC meeting discussion.
Provide feedback and education to study teams to facilitate successful protocol management.
Complete monitoring reports. Review PI and study team response to monitoring reports to ensure a satisfactory response or plan.
Identify site deficiencies and provide assistance with developing, implementing and evaluating Corrective and Preventive Action Plans (CAPAs).
Contribute to the ongoing development and improvement of forms, tools, templates and processes.
And other work as assigned.
Attend required clinical research and departmental staff meetings.
Participate in and complete designated and/or required training [Clinical Research Unit (CRU), Human Subject Research (HSR), CITI modules, MaestroCare, Beacon, IRB, etc.]
Effectively manage your workload, seeking help whenever it's needed. Communicate frequently with your manager, keeping them up-to-date on your work and issues as they arise. You will work closely with your manager to implement departmental & Duke Policy and initiatives.
Adherence to core work hours; time off requests will be submitted to your manager per departmental & Duke Policy. Patient care is our primary mission. When the unexpected happens you may be called upon to provide coverage outside your core work hours.
Know and comply with the regulations, rules and Standard Operating Procedures for your department, Duke Medical Center, School of Medicine, OncCRU and the Duke Office of Clinical Research.
Comply with Duke's rules, regulations and responsibilities as noted in The Duke Employee Handbook and on the Duke HR website.
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.
1392 CLINICAL RESEARCH ASSOCIATE I
Job Family Level
Full Time / Part Time
Regular / Temporary
Duke University is an Affirmative Action/Equal Opportunity Employee committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion,sexual orientation, or veteran status.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.
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
Nursing, Oncology Background, Clinical Research Background or Clinical Trials Monitoring Background.
- Excellent written, oral and conversational communication skills to effectively work with diverse groups.
- Ability to analyze, evaluate multiple solutions and solve complex problems using well developed critical & analytical thinking skills.
- Excellent time management skills needed to prioritize among many competing priorities.
- Attention to detail needed to operate accurately and effectively in the regulatory environment.
- Mastery of Microsoft Office.
Auto req ID
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.
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.