Research Manager

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What you will be doing

Research Manager, The Center for Regenerative Medicine

Position Summary

The Research Manager is responsible for the operational, regulatory, and administrative oversight of a portfolio of clinical, translational, outcomes, registry, and biorepository research studies of the Center for Regenerative Medicine. The Research Manager serves as a key liaison among investigators, research personnel, sponsors, institutional departments, and research administration to ensure the successful execution of research activities in compliance with federal regulations, sponsor requirements, institutional policies, and Good Clinical Practice (GCP) standards.

This position provides leadership for research operations, personnel management, quality assurance, regulatory compliance, and strategic initiatives while supporting the growth and advancement of the department's research mission. The Research Manager manages research staff, coordinates complex research portfolios, facilitates study implementation, and drives continuous improvement of research processes and infrastructure.

Essential Responsibilities

Research Operations Management

• Manage day-to-day research operations of the Center for Regenerative Medicine across a portfolio of clinical, translational, registry, biorepository and outcomes-based research studies.
• Manage study startup activities, study implementation, operational workflows, and research infrastructure needs.
• Coordinate research activities among investigators, research personnel, clinical staff, and institutional stakeholders.
• Lead protocol implementation meetings and facilitate ongoing study management meetings.
• Evaluate study feasibility, operational requirements, staffing needs, and resource utilization for proposed research initiatives.
• Monitor study progress, enrollment performance, milestones, deliverables, and project timelines.

Personnel Management and Leadership

• Recruit, supervise, mentor, and evaluate research personnel, including Research Assistants, Clinical Research Coordinators, Research Fellows, interns, and other research staff.
• Manage onboarding, orientation, training, competency assessment, and professional development activities.
• Manage staff assignments, workflows, scheduling, and workload distribution.
• Promote a collaborative, high-performing, and compliant research environment.

Regulatory Compliance and Research Quality

• Ensure departmental compliance with federal regulations, institutional requirements, sponsor obligations, and Good Clinical Practice standards.
• Maintain expertise in applicable research regulations, including FDA regulations, OHRP requirements, managing regulatory, compliance, human subjects’ protection, and institutional policies.
• Manage Institutional Review Board (IRB) submissions, amendments, continuing reviews, and study closures.
• Monitor research quality assurance and quality improvement activities.
• Conduct internal compliance reviews and audit readiness activities.
• Identify and mitigate regulatory, operational, and study-related risks.
• Provide guidance and consultation regarding protocol compliance and regulatory requirements.

Research Administration and Financial Management

• Support investigators and departmental leadership in research program planning and administration.
• Participate in study budget development, contract review, and financial feasibility assessments.
• Monitor research-related metrics, deliverables, and performance indicators.
• Develop reports and dashboards for investigators, sponsors, leadership, and regulatory agencies.
• Manage departmental research tracking systems, registries, and operational databases.

• Build and maintain strong partnerships with Clinical Research Administration, Clinical Operations, research laboratories and institutional stakeholders to streamline study activation and optimize study recruitment.

Data Management and Quality Oversight

• Support research data management processes to ensure data accuracy, completeness, integrity, and security. Monitor study databases, registries, and reporting systems. Implement data quality assurance procedures and corrective actions as needed. Support development of data collection tools, study workflows, and operational processes. 

Strategic Program Development

• Collaborate with department leadership to advance strategic research goals and priorities. Support the development of new research programs, registries, and collaborative initiatives. Recommend and implement process improvements that enhance research efficiency, compliance, and productivity. Assist with development and implementation of departmental standard operating procedures (SOPs). Promote a culture of scientific excellence, innovation, and continuous improvement. 

• Communication and CollaborationServe as the primary operational liaison between research teams, investigators, research administration, compliance offices, sponsors, and institutional departments. Facilitate communication regarding study progress, risks, operational issues, and resource needs. Represent departmental research activities in institutional committees, working groups, and collaborative forums as appropriate. Foster effective interdisciplinary partnerships that support research success. 

Minimum Qualifications/ Education

Bachelor's degree in Health Sciences, Biological Sciences, Public Health, Nursing, Healthcare Administration, Business Administration, or related field required. Master's degree preferred.

Experience

Minimum 5 years of progressively responsible clinical research experience. Experience coordinating or managing multiple research studies simultaneously. Experience supervising or mentoring research personnel preferred. Experience working with investigators, sponsors, research administration, and regulatory bodies.

Knowledge, Skills, and Abilities

Advanced knowledge of Good Clinical Practice (GCP), human subjects’ protection, HIPAA, FDA regulations, and research compliance requirements. Strong leadership, project management, and organizational skills. Ability to manage multiple complex projects and competing priorities. Strong analytical and problem-solving skills. Excellent verbal, written, and interpersonal communication skills. Experience with REDCap, Epic, CTMS platforms, electronic regulatory systems, and research databases preferred. Proficiency with Microsoft Office applications and data reporting tools. Ability to effectively supervise, mentor, and develop research personnel.

Preferred Qualifications

ACRP, SOCRA, PMP, or similar professional certification. Experience supporting investigator-initiated, industry-sponsored, and federally funded research. Experience with grant administration and budget management. Experience with quality management, auditing, and process improvement initiatives. Knowledge of specialty-specific clinical or scientific areas relevant to the hiring department.

Non-Discrimination Policy
Hospital for Special Surgery is committed to providing high quality care and skilled, compassionate, reliable service to our community in a safe and healing environment. Consistent with this commitment, Hospital for Special Surgery provides care, admits, and treats patients and provides all services without regard to age, race, color, creed, ethnicity, religion, national origin, culture, language, physical or mental disability, socioeconomic status, veteran or military status, marital status, sex, sexual orientation, gender identity or expression, or any other basis prohibited by federal, state, or local law or by accreditation standards.