This role represents an opportunity to register your interest in future Lead Clinical Research Associate positions within clinical trial management, roles that could guide multi-site studies from protocol development through data lock while maintaining the highest standards of patient safety and regulatory compliance. Please note the content of this advert does not represent a live vacancy. About the opportunity This is an opportunity to register your interest in future senior clinical research leadership roles. Lead Clinical Research Associates of this type may oversee complex, multi-site clinical trials within highly regulated therapeutic areas, working closely with sponsors, sites, and internal teams to ensure protocol adherence, data integrity, and timely study execution. The work could involve mentoring junior research coordinators, managing regulatory submissions, and driving compliance with FDA, ICH-GCP and institutional requirements while maintaining unwavering focus on patient safety outcomes. Typical role overview

Location:

Chicago, Illinois, United States Type:

Contract

•

Full-time Rate:

$560 - $800 per day

Domain:

Clinical research

• Regulatory affairs

• Multi-site trial management What you would do Typical responsibilities could include: Leading end-to-end management of multi-site clinical trials, from initiation through final data lock Developing, interpreting, and enforcing protocol compliance across all study sites Conducting and documenting regulatory submissions, safety reports, and audit-ready documentation Mentoring and supervising junior clinical research coordinators and support staff Managing relationships with clinical sites, sponsors, contract research organizations (CROs), and regulatory bodies Monitoring data integrity, ensuring accurate and timely case report form (CRF) completion and source document verification Preparing institutional review board (IRB) submissions and managing ongoing compliance approvals Identifying and mitigating protocol deviations and safety concerns with appropriate escalation What you could bring Most roles of this type require the following: 10-15 years of progressive clinical research experience, with a minimum of 2-5 years in a leadership or supervisory capacity Demonstrated expertise in multi-site clinical trial management, preferably within Phase II-IV studies Strong knowledge of FDA regulations, ICH-GCP guidelines, 21 CFR Part 11, and institutional compliance frameworks Bachelor's degree in Life Sciences, Biology, Chemistry, or a related healthcare discipline; advanced degree or clinical research certification (ACRP, SOCRA) preferred Proficiency with electronic data capture (EDC) systems, clinical trial management systems (CTMS), and regulatory documentation software Excellent written and verbal communication skills, with ability to interact confidently with sponsors, investigators, and regulatory agencies Proven ability to lead teams, mentor junior staff, and manage multiple concurrent studies Authorization to work in the United States What roles of this type could offer Most roles of this type offer the following, dependent on the industry and seniority of the role: Meaningful work supporting the advancement of novel therapeutics and patient care outcomes Leadership and mentoring opportunities to shape the next generation of clinical research professionals Exposure to diverse therapeutic areas and study designs within a regulated, quality-focused environment Potential for long-term engagement and project progression within the clinical research landscape Professional development support, continuing education opportunities, and potential pathways to principal investigator or operations leadership roles Competitive contract-based compensation, flexible work arrangements, and the opportunity to work on studies that directly impact patient health About Specialist Staffing Group Specialist Staffing Group connects clinical research, life sciences, and healthcare professionals with leading organizations and contract research providers. We support the delivery of high-quality clinical trials and regulatory programs by placing experienced, compliant professionals into roles where regulatory rigor, patient safety, and data integrity are paramount. How to register interest If you are interested in being added to our database to be considered for future opportunities, registering is quick and easy. No cover letter required. We will be in touch when we are instructed on these roles to discuss the next step in your career. Please note that the content of this advert does not represent a live vacancy or any guarantee of future vacancies, and by responding to this advert you agree to us adding your details to our database for future opportunities.