Clinical Research Supervisor

JOB SUMMARY

The Clinical Research Supervisor is responsible for providing day-to-day operational leadership across clinical research activities. This role focuses on workflow coordination, functional staff oversight, quality control, and ensuring that study-related activities are conducted accurately, efficiently, and in accordance with protocol and regulatory requirements.

The Supervisor serves as the first-line operational lead for clinical research staff—driving execution, resolving day-to-day challenges, monitoring performance, and ensuring the successful delivery of clinical trials. This role includes direct supervision of Clinical Research Coordinators and provides cross-functional leadership to other research support roles.

Key Responsibilities

Operational Leadership

• Oversee daily research operations, including visit scheduling, workflow coordination, and task prioritization.

• Ensure all staff adhere to study protocols, SOPs, GCP guidelines, and regulatory requirements.

• Troubleshoot operational issues and escalate complex challenges to the Clinical Research Manager as needed.

• Monitor timelines for study visits, data entry, query resolution, and documentation completion.

Staff Leadership & Development

• Provide direct supervision to Clinical Research Coordinators.

• Provide day-to-day direction, workflow coordination, and functional oversight for Study Coordinators, Recruiters/Screeners, Data Coordinators, and Lab Support Staff, in partnership with their respective supervisors.

• Manage daily staffing needs by balancing workloads and reallocating resources as necessary.

• Deliver real-time coaching, mentoring, and competency-based feedback to support staff performance.

• Lead onboarding and hands-on training for new hires.

• Support performance evaluations by contributing observations, metrics, and feedback to appropriate supervisors and the Clinical Research Manager.

Recruitment & Screening Execution

• Execute recruitment strategies, monitor performance metrics, and identify barriers to enrollment.

• Ensure consistent and accurate screening procedures across all studies.

• Optimize screening workflows to improve efficiency and participant engagement.

Quality Control & Data Integrity

• Conduct routine chart reviews, source-to-CRF reconciliation, and protocol compliance checks.

• Identify operational gaps and implement corrective actions in collaboration with leadership.

• Ensure protocol deviations, AEs/SAEs, and other reportable events are properly documented and escalated.

Sponsor & CRO Operational Support

• Serve as the operational lead during monitoring visits (SQVs, SIVs, IMVs, and close-out visits).

• Ensure staff, documentation, and study materials are prepared and audit-ready.

• Track and ensure timely completion of follow-up items and monitor requests.

Operational Support (As Needed)

• Provide hands-on support with patient visits, data review, specimen processing, or study procedures during high-volume or low-staff periods.

• Promote a culture of quality, accountability, and teamwork across all research functions.

Other functions and Responsibilities

This job description does not cover or contain a comprehensive listing of activities, duties, or responsibilities required for this job. In addition, duties, responsibilities, and activities may change at any time with or without notice.

COMPETENCIES

• Patient & Customer Focus

• Ethical Conduct

• Flexibility

• Initiative

• Personal Effectiveness/Credibility

• Stress Management/Composure

• Stress Management/Composure High attention to detail and strong organizational skills

• Excellent written and verbal communication skills

• Ability to work well independently

• Maintain confidentiality

• Experience with Microsoft Office Suite (Outlook, Word, Excel, PowerPoint)

• Possess strong skills for multitasking, meeting competing deadlines, prioritizing, and supporting PIs for multiple projects

QUALIFICATIONS

Required

• Bachelor’s degree in Life Science, Healthcare, or related field required.

• Minimum of 3 years of clinical research experience, including 1–2 years in a leadership, training, or lead role.

• Strong knowledge of clinical site operations, documentation standards, and recruitment workflows.

• Working knowledge of GCP, FDA regulations, ICH guidelines, and IRB requirements.

• Excellent communication, problem-solving, and organizational skills.

• Proven ability to lead and coordinate teams in a fast-paced, deadline-driven environment.

Preferred

• Nursing or Medical Degree

• HIPAA compliance

• Bilingual/Spanish

• Clinical Research Certification