CRC Operations Lead (32792)

GI Alliance; Lone Tree (CO); On-site; USD 90,000 - 120,000; Full time

Job summary

GI Alliance is seeking a CRC/Operations Lead to run clinical trials end-to-end and to act as a trusted resource for operational questions, staff training, and workflow support across sites.

You will guide staff on study protocols, policies and documentation, oversee onboarding, troubleshoot daily challenges, and collaborate with investigators and market leadership to ensure compliant, timely enrollment and high-quality data.

Qualifications

• Experience in managing clinical trials and coordinating multiple studies.
• Strong knowledge of FDA, GCP, ICH, and regulatory requirements.
• Ability to train, mentor and onboard staff.

Responsibilities

• Manage assigned clinical trials end-to-end, including participant visits, data collection, source documentation, and sponsor relations.
• Lead multiple studies with varying indications while ensuring protocol compliance.
• Provide day-to-day operational support and interpret study protocols and SOPs for staff.
• Support training and onboarding, and assist with administrative oversight such as timecard reviews.
• Attend site SIVs and sponsor meetings to ensure smooth start-up and expedited enrollment.
• Assist with feasibility activities and site visits, contributing to business development.
• Train and mentor CRCs, ensure Investigator relations, and maintain ALCOA-C documentation standards.
• Maintain certifications and knowledge of FDA, GCP, ICH, and state regulations.

Job description

Position Summary

The CRC/Operations Lead is a senior team member responsible for conducting clinical trials while also serving as a go-to resource for operational questions, training, and workflow support. In addition to managing their own study protocols, this individual provides guidance to staff on all site study protocols, site policies, and documentation practices. The CRC/Operations Lead supports training and onboarding, helps troubleshoot day-to-day challenges, and assists with administrative oversight, including timecard reviews. The distribution of work will be CRC/coordinating trials 75% and research operations lead duties 25%.

The CRC/Operations Lead is a senior team member responsible for conducting clinical trials while also serving as a go-to resource for operational questions, training, and workflow support. In addition to managing their own study protocols, this individual provides guidance to staff on all site study protocols, site policies, and documentation practices. The CRC/Operations Lead supports training and onboarding, helps troubleshoot day-to-day challenges, and assists with administrative oversight, including timecard reviews. The distribution of work will be CRC/coordinating trials 75% and research operations lead duties 25%.

Job Relationships

• Reports to the Director of Clinical Research, Vice President of Research, Regional Research Manager, Regional Market President, and the physicians at their market.
• Collaborates with experienced patient navigators, IT, data management, and Urology Alliance clinical research staff.

Key Responsibilities

• Manage assigned clinical trials end-to-end, including participant visits, data collection, source documentation, and sponsor relations.
• Able to manage multiple studies with varying indications.
• Leads complex trials, ensuring compliance with protocol and regulatory requirements.
• Develops effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials.
• Demonstrations understanding of the Urology Alliance and key stakeholders to ensure continuing of patient care.
• Work to build the research department in scope, size, reputation, and professionalism.
• Serve as a study resource for CRCs and support personnel.
• Provide day-to-day operational support, helping staff interpret study protocols, procedures, and SOPs.
• Maintain certifications in, and continually update knowledge of FDA, GCP, ICH, federal and state regulations, etc.
• Attend all site SIVs and other sponsor meetings to ensure smooth study start-up and expedited enrollment.
• Support study feasibility activities alongside Investigators and Site Managers.
• Attend site selection visits and support business development of the site.
• Train and mentor new and existing CRCs, including shadowing, skills checks, and protocol-specific training.
• Ensures good Investigator relations and manages training’s, schedules, and other communications/processes needed for Investigator support.
• Assist in creating and updating training materials and onboarding workflows.
• Support the Clinical Research Manager with administrative oversight, such as reviewing timecards, study/office supply needs, or visit scheduling concerns.
• Participate in site audits or monitoring visits, helping staff with compliance preparation.
• Help CRCs with reviewing monitoring visit follow-up letters to ensure the action items are completed in a timely manner.
• Oversight on binder management.
• Act as a liaison between individual market operations and leadership, elevating staffing, policy, or workflow concerns as needed.
• Ensure study conduct is compliant with GCP, IRB, SOPs, and ALCOA-C documentation standards.
• Act as the point person to the local market clinic and leadership teams.
• Work with the EMR and data management systems to complete EDC, eCRFs, find patients, maintain records.
• Support vendor management and vendor set up.
• Ensures CTMS compliance and completion.
• Partner with finance to ensure local site CTMS completion and proper invoicing.