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.