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 staffdriving 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 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

Bachelors degree in Life Science Healthcare or related field required.

Minimum of 3 years of clinical research experience including 12 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