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