Clinical Research Supervisor

Key Responsibilities

• 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.
• Maintain 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.

Competencies

• Patient & Customer Focus
• Ethical Conduct
• Flexibility
• Initiative
• Personal Effectiveness/Credibility
• 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

• Bachelor's 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.