Research - Laboratory/Non-Laboratory, Staff/Administrative
Location: Hyde Park Campus
1) The Senior Clinical Research Coordinator (Sr. CRC) is a specialized researcher partnering with the clinical Principal Investigator (PI) and under the direction of the Clinical Research Manager.
2) While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the Sr. CRC oversees,Â 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.
3) The Sr. CRC acts as a leader within the department/unit through improving clinical research practice and serves as a resource to others.
4) 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. other related aspects of the clinical study. 5) 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.
6) Act as a liaison with medical staff, university departments, ancillary departments and/or satellite facilities.
7) Serve as a resource person or act as a consultant within area of clinical expertise.
8) Act as a leader within the department/unit through improving clinical research practice and serving as a resource.
9) Maintain working knowledge of current protocols, and internal SOPs.
10) Be accountable for high standards of clinical research practice and assist in the development of accountability in others.
11) Develop and implement procedures, maintain records, track progress, and conduct quality assurance on data collected.
12) Oversee and participate in the coordination and conduct of complex clinical research studies and ensure compliance with federal and institutional regulations.
13) Prepare, submit, and assist Investigators with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
14) Provide Investigators with guidance regarding protocol requirements.
15) Maintain regulatory documentation.
16) Assist other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data and Safety Review Committee.
17) Prepare for and assist with audits, inspections, and monitoring visits from regulatory agencies or sponsors.
18) Provide direct supervision of other CRC staff (i.e. hiring/firing, performance evaluations, disciplinary actions, approve time off, etc.), or assist.
19) Attend continuing education and training opportunities relevant to job duties.
1) Ability to train junior CRCs.
2) Ability to participate in protocol review and clinical trials evaluations.
3) Excellent interpersonal skills.
4) Strong data management skills and attention to detail.
5) Ability to handle competing demands with diplomacy and enthusiasm.
6) Ability to work collaboratively with faculty and divisional clinical research infrastructure.
7) Excellent time management and ability to prioritize work assignments.
8) Ability to read and understand clinical trials protocols.
9) Familiarity with medical terminology/environment.
10) Working knowledge of Good Clinical Practices (GCP).
11) Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat.
1) Bachelor's degree
1) 5 years of clinical research experience coordinating multiple and variety of studies (e.g., investigator initiated; industry sponsored; multi-site trials).
2) Cover letter
Note: When applying, all required documents MUST be uploaded under the Resume/CV section of the application.
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Staff Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via the Applicant Inquiry Form.
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