Senior Clinical Research Coordinator

The University of Chicago; Harvey (IL); Hybrid; USD 70,000 - 85,000; Full time

Job summary

An established industry player is seeking a Senior Clinical Research Coordinator to lead and coordinate complex clinical trials. This role is pivotal in ensuring compliance with federal and institutional regulations while overseeing daily activities of clinical studies. The ideal candidate will have a strong background in clinical research, excellent interpersonal skills, and the ability to manage data effectively. Join a team that is at the forefront of cancer research, contributing to groundbreaking studies and improving patient outcomes. This position offers a dynamic work environment where your expertise will make a significant impact on clinical practices and research advancements.

Benefits

Health Insurance

Retirement Plans

Paid Time Off

Continuing Education Opportunities

Qualifications

• 5-7 years of experience in clinical research or related field.
• Strong understanding of clinical trials protocols and GCP.

Responsibilities

• Oversee daily activities of clinical trials ensuring compliance.
• Coordinate patient enrollment and manage clinical research data.

Skills

Clinical Research Coordination

Data Management

Interpersonal Skills

Problem Solving

Knowledge of Medical Terminology

Education

Bachelor's Degree

College or University Degree in Related Field

Tools

Microsoft Word

Microsoft Excel

Adobe Acrobat

Job description

Department

BSD CCC - Network Oncology Research Support

About the Department

The University of Chicago Comprehensive Cancer Center (UCCCC) is an integral component of the Biological Sciences Division (BSD). The BSD is the largest of four Divisions of the University and includes the Pritzker School of Medicine. UCCCC administers four established scientific programs, and the NCI-sponsored Cancer Center Support Grant provides funding for ten Shared Resources. The Comprehensive Cancer Center is comprised of over 190 faculty members from twenty departments with members currently being awarded over $47 million in total direct costs in peer-reviewed cancer research grants, and $28 million in non-peer reviewed grants and contracts. The activities of the Center are broad and varied, including research, training and education, communications, fundraising, marketing, clinical trials management and community outreach.

UCCCC has one of the largest cancer clinical trials programs in the country and in the Chicago area with nearly 500 adult and pediatric therapeutic trials actively accruing patients. Many of these studies are investigator-initiated, including Phase I or I/II trials, demonstrating UCCCC commitment to translate basic research findings to the clinic through proof-of-principle and early phase studies. UCCCC opens over 250 new trials each year and accrues approximately 900 participants to therapeutic trials each year.

Job Summary

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.

This position 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.

The job independently manages the collection, documentation, analysis of complex clinical studies, and reporting of clinical research data. Provides input into the strategic, administrative, and operational decisions that impact clinical research conducted across the University.

Responsibilities

• Assists with or plans and implements the clinical study goals and objectives; organizes patient enrollment planning; conducts quality assurance activities, compiles and analyzes data; processes blood and urine specimens.
• Acts as a liaison with medical staff, University departments, ancillary departments and/or network facilities.
• Acts as a leader within the department/unit through improving clinical research practice; serves as a resource person or acts as a consultant within area of clinical expertise.
• Maintains working knowledge of current protocols, and internal SOPs.
• Accountable for high standards of clinical research practice and assists in the development of accountability in others.
• Develops and implements procedures, maintains records, tracks progress, and conduct quality assurance on data collected.
• Oversees and participates in the coordination and conduct of complex clinical research studies and ensures compliance with federal and institutional regulations. Prepares, submits, and assists Investigators with multiple levels of research documentation, i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms.
• Provides investigators with guidance regarding protocol requirements. Maintains regulatory documentation.
• Assists other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data and Safety Review Committee.
• Prepares for and assists with audits, inspections, and monitoring visits from regulatory agencies or sponsors.
• Attends continuing education and training opportunities relevant to job duties.
• Accountable for all tasks in complex clinical studies.
• Performs various professional, organizational, and operational tasks under limited supervision. Acts as a resource on clinical research and related aspects of clinical study for other clinical research staff. Accountable for complex problem solving on assigned clinical research studies and professional tasks.
• Facilitates and participates in the daily activities of complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits. Uses in-depth knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a high degree of independence.
• Performs other related work as needed.

Minimum Qualifications

Education: Minimum requirements include a college or university degree in related field.

Work Experience: Minimum requirements include knowledge and skills developed through 5-7 years of work experience in a related job discipline.

Certifications: ---

Preferred Qualifications

Education:

• Bachelor’s Degree.

Experience:

• Experience with clinical trials protocols.
• Familiarity with medical terminology/environment.
• Working knowledge of Good Clinical Practices (GCP).
• Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat.

Licenses and Certifications:

• Research certification, e.g., SoCRA, ACRP, Graham School Clinical Trials Management and Regulatory Compliance.

Preferred Competencies

• Excellent interpersonal skills.
• Strong data management skills and attention to detail.
• Handle competing demands with diplomacy and enthusiasm.
• Work collaboratively with faculty and divisional clinical research infrastructure.
• Excellent time management and prioritize work assignments.

Working Conditions

• Ability to bend, crouch, or stoop.
• Ability to lift loads up to 49lbs.
• Hybrid position with majority of work being done in-person/ on-site.

Application Documents

• Resume (required)
• Cover letter (preferred)

When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.

Job Family

Research

Role Impact

Individual Contributor

Scheduled Weekly Hours

40

Drug Test Required

Yes

Health Screen Required

Yes

Motor Vehicle Record Inquiry Required

No

Pay Rate Type

Salary

FLSA Status

Exempt

Pay Range

$70,000.00 - $85,000.00

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

Yes

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 the Benefits 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.

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