Senior Clinical Research Coordinator

Department

BSD MED - Dermatology - Administrative Support

About the Department

The Section of Dermatology at The University of Chicago has a long and distinguished history. Our group comprises 14 full-time dermatologists, four part-time dermatologists, and one full-time research faculty with expertise in dermatopathology, dermatologic surgery, including Mohs surgery, lymphoma, pediatric dermatology, pigmented lesions and melanoma, wound care and general dermatology. In addition, the Section has long-established training programs in dermatology (11 residents) and dermatopathology (2 fellows), where we take great pride in producing the future clinicians, researchers and educators in the field.

Job Summary

The Senior Clinical Research Coordinator will oversee the Section-wide clinical research portfolio across the lifecycle for each protocol from feasibility, startup, recruitment, day-to-day conduct, follow-up through study close out.

Responsibilities

• Mentors or trains staff to communicate effectively with CRO and/or sponsor, and in managing and conduct site visits. Understands the relationship between sites, sponsors and CROs in order to solve problems.

• Plans and manages the protocol review process for all clinical trials which includes the receipt and coordination of protocols for review, committee meetings, and clinical research conferences.

• Creates and maintains departmental infrastructure for scientific review, feasibility assessment and projected effort/protocol.

• Ensures research projects progress according to plan by overseeing the coordination of the daily clinical trial activities.

• Collaboration with departmental and divisional stakeholders for clinical research.

• Advises the development of a formalized training program for both new and existing staff within the unit and any affiliates and/or partners.

• Works with leadership, advisory compliance committee members and research unit leaders to establish a culture of research compliance.

• Determines and manages complex study and equipment resources for more than one study, and processes related to their management. Forecasts study needs, including staffing. Effectively solves complex problems related to managing resources.

• Manage relationships across the program and the institution.

• Implements detailed complex operational plans for research protocols.

• Partner with faculty to set site performance metrics and targets. Measures impact of preventative and corrective actions.

• Training and onboarding of all research staff in GCP, 21 CFR 11, 21 CFR 312, 21 CF 812 and divisional policies for the conduct of clinical research.

• 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 oversight on the administration of the compliance, financial, personnel and other related aspects of the clinical studies. other related aspects of the clinical study.

• 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.

• Develop standard operating procedures for team in compliance with institutional, state and federal regulatory policies, procedures, directives and mandates. Generate routine assessment tools to ensure staff are operating within standards, and address deficiencies with resources.

• As required, support and facilitate the submission of new research proposals. Take part in research design, assistant 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.

• Provides oversight to CRCs, including training coordinators on projects, managing schedules, addressing their questions and ensuring they have the resources and tools they need to conduct the research activities on a daily basis with a high standard of performance.

• Solves complex problems relating to data management and the analysis of large administrative datasets. Works independently to develop, manage, and report on key data and ensures timeliness of data and reporting submissions from multiple investigators.

• Acts as a resource on the basics of clinical research and related aspects of clinical study for colleagues with less experience. Prepares and evaluates writing protocols, IRB submissions, grant applications, manuscripts, reports, and dissemination tools.

• Partner with PI(s) to coordinate administrative aspects research grant proposals.

• Ensure laboratory day-to-day operations are running efficiently.

• Assist with coordination of research related conferences and events.

• Accountable for all tasks in complex clinical studies.

• 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 coordinating multiple studies (e.g., investigator initiated, industry sponsored, multi-site trials).

• Regulatory support for IRB filings.

• Protocol development support experience.

Preferred Competencies

• Ability to communicate with tact and diplomacy.

• Strong organizational skills.

• Strong communication skills (verbal and written).

• Ability to communicate with tact and diplomacy.

• Ability to handle sensitive matters with tact and discretion.

• Excellent interpersonal skills.

• Strong data management skills and attention to detail.

• Ability to participate in protocol review and clinical trials evaluations.

• Knowledge of medical terminology / environment.

• Ability to handle competing demands with diplomacy and enthusiasm.

• Excellent time management and ability to prioritize work assignments.

• Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat.

• Familiarity with Good Clinical Practices (GCP).

• Ability to read and understand clinical trials protocols.
   

Application Documents

• Resume/CV (required)

• Cover Letter (required)

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.

 

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.