Senior Research Specialist

Job Location: 601 Elmwood Ave, Rochester, New York, United States, 14642

Full-time, 40 scheduled weekly hours

Compensation Range: $64,200.00 - $96,200.00

Responsibilities

• Provide laboratory leadership and programmatic support for the Division of Pediatric Infectious Disease research program.
• Oversee current and future NIH, CDC, and industry-funded research grants, including the New Vaccine Surveillance Network and clinical studies evaluating novel vaccines for RSV, Pneumococcus, and other pathogens.
• Manage the Pediatric Infectious Diseases research laboratory, including oversight of both laboratory-based and clinical research activities.
• Ensure project management for all required study activities within specified timeframes.
• Supervise and train laboratory personnel and trainees.
• Oversee laboratory specimen operations and ensure compliance with all institutional, regulatory, and sponsor requirements.
• Perform immunologic and molecular assays, with occasional development of new laboratory assays in conjunction with the Principal Investigator.
• Collaborate with sponsors, departmental administration, and the Office of Clinical Research (OCR) to support the development, implementation, and management of clinical research projects.
• Coordinate study startup, develop clinical research budgets with OCR, monitor program deliverables, and support the preparation and submission of research proposals.
• Serve as the liaison with sponsors, regulatory agencies, partner institutions, and University stakeholders to coordinate laboratory-based and clinical research activities.
• Support leadership in planning and resource allocation, track milestones and deliverables, and proactively resolve challenges.
• Engage with sponsors, collaborators, professional organizations, and other institutions to strengthen partnerships and advance program objectives.
• Supervise staff and contribute to long-term program planning and growth.

Essential Functions

Program Leadership & Coordination

• Partner with program directors, research staff, and senior administrators to plan, initiate, and oversee all research program activities, ensuring alignment with institutional goals and sponsor requirements.
• Oversee the allocation and effective use of staff, space, equipment, and other resources to support research activities and program growth.
• Assist in leading internal meetings, monitor progress toward team goals, and disseminate project information to appropriate parties.

Laboratory Management

• Write and implement detailed Standard Operating Procedures for laboratory procedures.
• Perform complex experiments, including qPCR, multiparameter flow cytometry, ELISpot assays, and ELISAs, and analyze resulting data.
• Prepare study methods and figures for publication.
• Manage sample databases/inventories and prepare shipments to study sponsors and collaborators following IATA regulations.
• Maintain laboratory space and adhere to relevant biosafety standards.

Study Start Up

• Coordinate and support the preparation, submission, and monitoring of research proposals, contracts, and subcontracts.
• Work with the Study Principal Investigator (PI)/Study Nurse Manager and OCR to negotiate clinical study budgets and implement study protocols, amendments, and grants.
• Assist the study team with development and execution of pre-trial activities.

Study Maintenance

• Serve as a primary liaison with sponsors, regulatory agencies, collaborating institutions, and internal departments, fostering strong partnerships and clear communication.
• Respond to laboratory-based queries from study sponsors and monitors.

Training and Management

• Oversee other technicians and trainees in the laboratory on a day-to-day basis, coordinating and guiding experiments, and providing troubleshooting as required.

Professional Development

• Participate in protocol-related training as required.
• Develop, implement, and maintain best practices for administrative and operational procedures to ensure efficiency, compliance, and long-term program sustainability.

Other duties as assigned per the study needs.

Requirements

• Bachelor's degree and 5 years of related work experience involving direct assistance to researchers required.
• Master's degree preferred.
• PhD preferred.
• Equivalent combination of education and experience considered.
• Experience as a Laboratory Manager preferred.

Skills

• Ability to troubleshoot and repair equipment as needed.
• Excellent word processing, spreadsheet, database, and data analysis software experience preferred.
• Fully adheres to applicable safety and/or infection control standards preferred.
• Ability to mentor and provide training to junior members of the team preferred.
• Ability to effectively manage complex research protocols/procedures preferred.
• High degree of self-motivation preferred.
• Recognized ability to function independently preferred.
• Proficient in managing multiple and competing priorities/demands preferred.
• Detailed-oriented in record keeping and research documentation preferred.
• Understands and follows data integrity standards and processes preferred.
• Strong interpersonal, communication, and organizational skills preferred.
• Thorough knowledge of and established track record in assuring GCP, HSPP, Responsible Conduct of Research standards, and applicable safety standards preferred.
• Ability to build collaboration among research team members, patients and families, clinical services (requires tact, sensitivity, clarity, flexibility, empathy for patients) preferred.