Epilepsy Clinical Trials Ops Manager

Minnesota Epilepsy Group; Roseville (CA); On-site; USD 110,000 - 140,000; Full time

Job summary

Minnesota Epilepsy Group, P.A. seeks a Research Manager to oversee planning, coordination, and execution of clinical research in an outpatient neurology/epilepsy setting.

You will lead study teams, manage regulatory and data quality, and collaborate with investigators and sponsors to deliver patient-centered epilepsy trials. You will supervise coordinators, develop workflows, ensure GCP/HIPAA compliance, and optimize recruitment while maintaining high safety and ethical standards in outpatient

Qualifications

• Several years of clinical research experience, preferably in neurology, epilepsy, or another specialty clinical research environment.
• Experience coordinating or managing clinical trials.
• Knowledge of GCP, IRB requirements, informed consent, HIPAA, and applicable clinical research regulations.
• Demonstrated ability to manage multiple studies, competing priorities, and time-sensitive deliverables.
• Experience providing leadership, supervision, or mentorship to research staff.
• Strong organizational, communication, problem-solving, and interpersonal skills.

Responsibilities

• Oversee day-to-day operations of clinical trials and research studies conducted within the outpatient practice.
• Coordinate study start-up, including feasibility assessments, site activation, regulatory documentation, staff training, and study implementation.
• Develop and maintain study-specific workflows, timelines, tracking tools, and standard operating procedures.
• Monitor study enrollment, recruitment, retention, visit completion, and overall study performance.
• Coordinate research activities with routine epilepsy and neurology clinical care.
• Identify operational barriers and develop solutions to maintain study timelines and quality.
• Support clinical research involving epilepsy, seizure disorders, antiseizure medications, devices, diagnostics, and other neurological therapies as applicable.
• Coordinate protocol-required patient visits, assessments, laboratory testing, imaging, EEG-related procedures, medication management, and follow-up activities.
• Work closely with physician investigators and clinical staff to ensure protocol requirements are incorporated appropriately into patient care workflows.
• Support identification and screening of potentially eligible patients while maintaining appropriate privacy and ethical standards.
• Supervise, mentor, and provide day-to-day direction to research coordinators and other research personnel.
• Assign responsibilities and workload based on study requirements and staff competencies.
• Develop onboarding and continuing education programs for research personnel.
• Ensure research staff maintain competency in study protocols, informed consent, GCP, regulatory requirements, and applicable clinical procedures.
• Participate in recruitment, performance evaluation, professional development, and retention of research staff.
• Ensure research activities comply with study protocols, IRB requirements, Good Clinical Practice (GCP), HIPAA, FDA requirements, and applicable institutional policies.
• Oversee preparation and maintenance of regulatory and essential study documentation/investigator site files.
• Coordinate IRB submissions, amendments, continuing reviews, safety reports, and study closeout activities.
• Monitor and address protocol deviations, compliance concerns, and corrective/preventive actions.
• Maintain readiness for sponsor monitoring visits, audits, and regulatory inspections.
• Develop strategies to improve recruitment and enrollment for epilepsy clinical trials.
• Monitor recruitment metrics and identify opportunities to improve participant identification and retention.
• Promote a patient-centered research experience appropriate for individuals with epilepsy and their families/caregivers.
• Ensure informed consent and research participation processes are conducted appropriately and ethically.
• Coordinate research visits to minimize disruption to patients’ routine clinical care.
• Oversee accurate, complete, and timely collection of clinical research data.
• Monitor electronic data capture systems and ensure timely resolution of data queries.
• Review study documentation for accuracy, completeness, and protocol compliance.
• Track key performance indicators related to enrollment, data quality, visit completion, and study timelines.
• Implement quality-improvement processes to strengthen research operations.
• Serve as an operational point of contact for pharmaceutical/biotechnology sponsors, CROs, vendors, and research partners.
• Coordinate sponsor meetings, monitoring visits, site communications, and follow-up activities.
• Communicate study progress, enrollment status, operational issues, and corrective actions to investigators and study partners.
• Assist with study budgets, invoices, contracts, and resource planning as appropriate.

Skills

Clinical research management

GCP compliance

IRB management

Data quality management

Sponsor/CRO relationship management

Project and time management

Cross-functional collaboration

Patient-centered communication

Job description

Minnesota Epilepsy Group, P.A. seeks a Research Manager to oversee planning, coordination, and execution of clinical research in an outpatient neurology/epilepsy setting.

You will lead study teams, manage regulatory and data quality, and collaborate with investigators and sponsors to deliver patient-centered epilepsy trials. You will supervise coordinators, develop workflows, ensure GCP/HIPAA compliance, and optimize recruitment while maintaining high safety and ethical standards in outpatient