Job Summary:
The Sr. Clinical Research Coordinator within the Ophthalmic Clinical Trials and Translational Center (OCTTC) is responsible for managing, coordinating, and implementing all components of clinical research protocols, including pre and post-research activities both within and outside the clinical setting. This role encompasses overseeing complex research projects, maintaining compliance with study protocols, and developing patient recruitment strategies. Key responsibilities include preparing IRB submissions, regulatory document preparation, and ensuring adherence to all regulatory requirements and guidelines. Additionally, the Sr. Clinical Research Coordinator functions as a managerial figure within the OCTTC, advancing research initiatives, providing guidance and support to junior team members, and fostering a collaborative and productive research environment.
Primary Responsibilities
Clinical Research Coordination
- Assist in establishing and coordinating the implementation of clinical research protocol priorities and organization structure.
- Assist in the preparation and setting up of wet labs as needed for various sponsors.
- Train staff on research protocols and procedures.
- Serve as a resource for team members, offering expertise and assistance with complex study-related tasks or challenges.
- Extract data from complex medical records with expert accuracy.
- Notify and inform PI, physicians, clinical staff, affiliates and grant sponsors of adverse events and protocol modifications, including their impact on the clinical research program.
- Coordinate the activation and maintenance of clinical protocols, including review and completion of submissions, amendments, and adverse event reports as required by the UIC Institutional Review Board (IRB), Protocol Review Committee and grant sponsors.
- Review laboratory and clinical procedures and evaluations regularly to ensure protocol compliance.
- Act as liaison between physicians, clinical staff and the UIC IRB office, grant sponsors and regulatory agencies to ensure priorities are clearly communicated and resources are allocated appropriately across multiple ongoing projects.
- Communicate clinical information and work with stakeholders to create best practice tools.
- Represent the clinical research team in meetings with investigators, sponsors, regulatory agencies, and other stakeholders.
Client Enrollment and Protocol Compliance
- Assist PI, physicians and clinical staff in identification, recruitment and enrollment strategies of patients to increase enrollment and to meet clinical research protocols.
- Schedule and conduct clinical research visits required by the protocol and track participant visits.
- Schedule all patient examinations, repeat examinations, treatments and laboratory visits required by the protocol.
- Coordinate outreach to and liaison with staff at schools, community clinics, etc. to make research presentations and recruit new clients for various research projects.
- Screen patients for protocol eligibility and participation in clinical research.
- Execute informed consent process and monitor patient status; Enroll clients into programs, explaining the research protocols to the clients and parents, and obtain appropriate consent forms.
- Ensure that client enrollment and research activities comply with established protocols, regulatory and monitoring agency standards, and grant sponsor guidelines.
- Collect and review client evaluations/assessments, surveys, and participant interviews to develop reports for the PI and appropriate agencies and grant sponsors.
- Complete accurate, concise, and legible documentation of all participant records and other source documentation and forms per protocol, (i.e. maintain drug documentation, reconciling study drug accountability).
- Participate in required clinical research education and training programs.
- Performs other duties and special projects as assigned
Minimum Qualifications
- A minimum of a Bachelor's degree in nursing, mental health, psychology, pharmaceutical sciences, social science, or a related field required.
- A minimum of 5 years of experience in a research discipline required.
- Experience in a clinical research setting, experience working with Federal Regulations and IRB's.
- Strong knowledge of clinical research regulations, including Good Clinical Practice (GCP) guidelines and FDA regulations.
- Prior experience with medical terminology and procedures.
- Proficiency in EPIC, RedCap, EDC, Microsoft Office Suite, and other relevant software applications.
- Ability to manage multiple tasks in a fast-paced environment.
- Effective communication and interpersonal skills, with the ability to collaborate effectively
- Strong interpersonal and customer service skills. Requires excellent communication, organization, presentation and computer/pc skills.
Preferred Qualifications
- Master's degree is preferred.
- Certified Clinical Research Coordinator (CCRC) preferred.
To apply, please visit: https://uic.csod.com/ux/ats/careersite/1/home/requisition/9946?c=uic and upload:
- CV
- Cover letter highlighting your technical and organizational abilities
- Names and contact information for 3 references
For fullest consideration, please submit an application by 06/24/24
The University of Illinois conducts background checks on all job candidates upon acceptance of contingent offer employments. Background checks will be performed in compliance with the Fair Credit Report Act.
The University of Illinois at Chicago is an affirmative action, equal opportunity employer that has a strong institutional commitment to the principle of diversity and is particularly interested in receiving applications from a broad spectrum of people. We are committed to equal employment opportunities regardless of sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
The University of Illinois System requires candidates selected for hire to disclose any documented finding of sexual misconduct or sexual harassment and to authorize inquiries to current and former employers regarding findings of sexual misconduct or sexual harassment. For more information, visit https://www.hr.uillinois.edu/cms/One.aspx?portalId=4292&pageId=1411899
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