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An established industry player seeks a Clinical Research Coordinator 2 to oversee and manage clinical trials in a dynamic research environment. This role involves coordinating daily activities, ensuring compliance with regulations, and facilitating patient recruitment. The successful candidate will work closely with Principal Investigators and research teams to support innovative clinical studies. Join a forward-thinking institution that values original ideas and empowers individuals to challenge conventional thinking. This is an exciting opportunity to contribute to groundbreaking research that can change lives.
Clinical Research Coordinator 2 page is loaded
Department
BSD MED - Rheumatology - Reid Research Staff
About the Department
Job Summary
Responsibilities
Manages all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.
Recruit and interview potential study patients with guidance from PI and other clinical research staff.
Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.
Identify and explain the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.
Coordinate the conduct of the study from startup through closeout including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.
Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.
Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and the risks and benefits of the procedures.
Performs assessments at visits and monitors for adverse events.
Organizes and attends site visits from sponsors and other relevant study meetings.
Protect patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.
Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.
Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.
Understand the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions independently.
Ensures compliance with federal regulations and institutional policies.
May prepare and maintain protocol submissions and revisions.
May assist in the training of new or backup coordinators.
Facilitates and participates in the daily activities of moderately complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits.
Accountable for all tasks in moderately complex clinical studies.
Performs other related work as needed.
Minimum Qualifications
Education:
Minimum requirements include a college or university degree in related field.
Work Experience:
Certifications:
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Preferred Qualifications
Education:
Bachelors degree.
Experience:
Clinical research experience or relevant experience.
Experience coordinating multiple studies (e.g., investigator initiated, industry sponsored, multi-site trials).
Preferred Competencies
Ability to be aware of safety hazards and take appropriate precautions.
Ability to communicate in writing.
Ability to communicate orally.
Ability to comprehend technical documents.
Ability to condense complicated issues to simple summaries that can be understood by a variety of constituents.
Ability to create and deliver presentations.
Ability to develop and manage interpersonal relationships.
Ability to exercise absolute discretion regarding confidential matters.
Ability to follow written and/or verbal instructions.
Ability to give directions.
Ability to handle sensitive matters with tact and discretion.
Ability to handle stressful situations.
Ability to learn and develop skills.
Ability to maintain a high level of alertness.
Ability to pay attention to detail.
Ability to perform multiple tasks simultaneously.
Ability to prioritize work and meet deadlines.
Ability to react effectively, quickly, calmly, and rationally during conflicts and emergencies.
Ability to train or teach others.
Ability to work effectively and collegially with little supervision or as member of a team.
Ability to work independently.
Application Documents
Resume (required)
Cover Letter (required)
When applying, the document(s) MUSTbe uploaded via the My Experience page, in the section titled Application Documents of the application.
Job Family
Role Impact
Scheduled Weekly Hours
Drug Test Required
Health Screen Required
Motor Vehicle Record Inquiry Required
Pay Rate Type
FLSA Status
Pay Range
The included pay rate or range represents the University’s good faith estimate of the possible compensation offer for this role at the time of posting.
Benefits Eligible
The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in theBenefits Guidebook .
Posting Statement
The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.
Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via Applicant Inquiry Form.
All offers of employment are contingent upon a background check that includes a review of conviction history.A conviction does not automatically preclude University employment.Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.
The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: http://securityreport.uchicago.edu .Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.
The University of Chicago is an urban research university that has driven new ways of thinking since 1890. Our commitment to free and open inquiry draws inspired scholars to our global campuses, where ideas are born that challenge and change the world.
We empower individuals to challenge conventional thinking in pursuit of original ideas. Students in the College develop critical, analytic, and writing skills in our rigorous, interdisciplinary core curriculum. Through graduate programs, students test their ideas with UChicago scholars, and become the next generation of leaders in academia, industry, nonprofits, and government.