Clinical Research Coordinator Lead

Job Description

Location: Chicago, Illinois

Business Unit: Rush Medical Center

Hospital: Rush University Medical Center

Department: Pediatric Neurology Research

Work Type: Full Time (Total FTE between 0.9 and 1.0)

Shift: Shift 1

Work Schedule: 8 Hr (8:00:00 AM – 4:30:00 PM)

Rush offers exceptional rewards and benefits learn more at our Rush benefits page (https://www.rush.edu/rush-careers/employee-benefits).

Pay Range: $32.00 – $46.44 per hour

Rush salaries are determined by many factors including, but not limited to, education, job-related experience and skills, as well as internal equity and industry specific market data. The pay range for each role reflects Rush’s anticipated wage or salary reasonably expected to be offered for the position. Offers may vary depending on the circumstances of each case.

Summary:

The Lead Clinical Research Coordinator provides advanced coordination, may lead project-driven research and operational leadership for a portfolio of clinical trials. This role supports departmental oversight by supervising CRC I–III staff, resolving operational barriers, liaising with sponsors and regulatory partners, and ensuring standardization and quality across clinical research processes. The Lead CRC may serve as an interim manager, supports onboarding and training efforts, and contributes to departmental planning, audit response, and portfolio coordination. This position exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures.

Required Job Qualifications:

Education:

• Bachelor’s degree

Experience:

• 3+ years of progressive clinical research coordination

• Independent site management experience

OR

Experience (in lieu of a degree)

5 years of experience coordinating clinical trials of increasing complexity, including mentoring junior coordinators and serving as the primary point of contact for study teams.

Knowledge, Skills, & Abilities:

• Regulatory Knowledge — Applies GCP, FDA, NIH, and IRB rules across multiple studies; supports staff in understanding and applying complex regulatory requirements.

• Regulatory Compliance — Tracks team-wide compliance, identifies gaps, and corrects reporting or documentation issues before they escalate.

• Project & Time Management — Leads timelines, task tracking, and team coordination for multiple studies; adjusts resources to meet study goals.

• Problem-Solving & Critical Thinking — Uses good judgment to solve study and team-level problems; handles complex challenges and makes protocol-aligned decisions.

• Detail & Organization — Reviews and standardizes documentation across study teams; ensures records are accurate, complete, and audit-ready.

• Participant & Vendor Interaction — Maintains respectful, professional communication with participants, sponsors, vendors, and partners; ensures team alignment with protocols.

• Communication Skills — Communicates clearly with staff, sponsors, CROs, and auditors; prepares summaries, updates, and responses as needed.

• Teamwork & Supervision — Supports CRC I–III staff by providing feedback, resolving questions, and helping the team meet performance expectations.

• Flexibility — Adjusts work schedule to support high-priority study tasks, staff supervision, or sponsor visits.

• Travel Readiness — Able to travel locally or regionally to support site visits, sponsor meetings, or team supervision.

Preferred Job Qualifications:

Education:

• Master’s degree or equivalent

Experience:

• Managing NIH, pharmaceutical, or device clinical trials

• Strong background in research coordination

• Prior supervising or mentoring research staff

Certifications:

• Relevant certification strongly preferred (Certified Clinical Research Professionals (CCRP),

• Certified Clinical Research Associate (CCRA),

• Certified Clinical Research Coordinator (CCRC), OR

• Certified IRB Professional (CIP)

Responsibilities:

1. Oversees participant enrollment efforts across multiple studies and study teams, ensuring consistency in eligibility screening, consent documentation, scheduling, and follow-up.

2. Oversees CRC data entry practices and provides real-time guidance to ensure that data entered into CRFs and EDC systems is complete, accurate, and source-verified.

3. Coordinates department-wide protocol submissions and amendments; serves as liaison to IRB and regulatory offices for active and upcoming studies.

4. Reviews documentation across studies and staff for completeness, accuracy, and readiness for sponsor/regulatory audit; standardizes source documentation practices within the department.

5. Leads department-wide source documentation and data entry oversight by setting expectations for 100% source verification, monitoring staff adherence, and implementing corrective workflows to ensure complete, accurate, and audit-ready data across all studies.

6. Advises CRC staff on appropriate specimen handling workflows across trials; resolves process gaps affecting specimen integrity or chain-of-custody.

7. Provides technical oversight of CRC-conducted assessments, ensuring training compliance, protocol accuracy, and consistent participant experience across study teams.

8. Serves as lead departmental liaison with sponsors, CROs, regulatory bodies, and internal stakeholders; addresses performance concerns, clarification needs, and documentation queries.

9. Leads team and department audit preparation; coordinates internal monitoring, standardizes documentation practices, and ensures timely implementation of corrective action plans.

10. Reviews safety event documentation across studies; provides coaching and follow-up with CRCs to ensure timely and appropriate AE/SAE and deviation reporting.

11. Implements department-level process improvements in coordination with Research Manager; identifies training gaps and operational inefficiencies for intervention.

12. Directly supervises CRC I–III staff, including onboarding, delegation of tasks, performance coaching, and annual evaluations. Supports team cohesion and role progression through mentorship.

13. Supports Research Manager by coordinating portfolio-level study oversight, managing workload distribution, and contributing to feasibility, resourcing, and departmental planning conversations.

14. Leads the development and execution of comprehensive project plans for clinical research studies, including timeline management, resource allocation, budget oversight, and coordination among cross-functional teams to ensure adherence to study protocols and regulatory requirements.

15. Other duties as assigned.

Rush is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

Position Clinical Research Coordinator Lead

Location US:IL:Chicago

Req ID 23368