Senior Clinical Research Coordinator
Hyde Park Campus
About the Unit
The Senior Clinical Research Coordinator (Sr CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). While the Principal Investigator is primarily responsible for the overall design, conduct, and management of clinical trials, the Sr CRC oversees, facilitates and coordinates the daily activities of complex clinical trials and plays a critical role in the conduct of the studies to ensure compliance with federal and institutional regulations. The Sr CRC acts as a leader within the department/unit through improving clinical research practice and serves as a resource to others. By performing these duties, the Sr. CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical studies.
Research Conduct/Study Management:
- Assist with or plan and implement the clinical study's goals and objectives; organize patient enrollment planning; conduct quality assurance activities, compile and analyze data.
- Act as a liaison with medical staff, university departments, ancillary departments and/or satellite facilities.
- Serve as a resource person or act as a consultant within area of clinical expertise.
- Act as a leader within the department/unit through improving clinical research practice and serving as a resource.
- Maintain working knowledge of current protocols, and internal SOPs.
- Be accountable for high standards of clinical research practice and assist in the development of accountability in others.
- Develop and implement procedures, maintain records, track progress, and conduct quality assurance on data collected.
- Oversee and participate in the coordination and conduct of complex clinical research studies and ensure compliance with federal and institutional regulations.
- Prepare, submit, and assist Investigators with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
- Provide Investigators with guidance regarding protocol requirements.
- Maintain regulatory documentation.
- Assist other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data and Safety Review Committee.
- Prepare for and assist with audits, inspections, and monitoring visits from regulatory agencies or sponsors.
- Provide direct supervision of other CRC staff (i.e. hiring/firing, performance evaluations, disciplinary actions, approve time off, etc.), or assist.
- Attend continuing education and training opportunities relevant to job duties.
- Other duties as assigned.
- Ability to train junior CRCs required.
- Ability to participate in protocol review and clinical trials evaluations required.
- Excellent interpersonal skills required.
- Strong data management skills and attention to detail required.
- Ability to handle competing demands with diplomacy and enthusiasm required.
- Ability to work collaboratively with faculty and divisional clinical research infrastructure required.
- Excellent time management and ability to prioritize work assignments required.
- Ability to read and understand clinical trials protocols required.
- Familiarity with medical terminology/environment required.
- Working knowledge of Good Clinical Practices (GCP) required.
- Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat required.
- Research certification (e.g., SoCRA, ACRP, Graham School Clinical Trials Management & Regulatory Compliance) preferred.
Education and Experience:
- Bachelor's degree required.
- Minimum of 5 years of clinical research experience coordinating multiple and variety of studies (e.g., investigator initiated; industry sponsored; multi-site trials) required.
- Certification in Principles and Practice of Clinical Research or similar training preferred.
- Cover Letter
NOTE: When applying, all required documents MUST be uploaded under the Resume/CV section of the application
Depends on Qualifications
Scheduled Weekly Hours
Job is Exempt?
Drug Test Required?
Does this position require incumbent to operate a vehicle on the job?
Health Screen Required?
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