Post Doc Research Associate - Clinical Research Coordinator

Rochester Institute of Technology’s Respiratory Technologies Laboratory is seeking a highly motivated Postdoctoral Research Associate to support an FDA-sponsored clinical research program focused on tobacco regulatory science.

About the role

The Postdoctoral Research Associate will serve as the primary study coordinator (project manager) for a three-year clinical trial investigating tobacco product use and its impact on human health and behavior. This multidisciplinary research program examines tobacco product use from multiple perspectives, including puffing and inhalation topography, user behavior, subjective effects, aerosol emissions, toxicity, biomarker assessment, and exposure modeling. The ultimate goal is to generate scientific evidence that informs tobacco product regulation and improves public health.

Responsibilities

• Serve as the primary study coordinator (project manager) for a three-year FDA-sponsored clinical trial.
• Conduct all aspects of the study including engagement marketing, participant recruitment, screening, scheduling, enrollment, compliance, and retention activities.
• Conduct participant laboratory visits and collect study data according to protocol requirements.
• Monitor participant compliance with study procedures and follow-up activities.
• Coordinate engagement of study medical providers and clinical nursing staff.
• Maintain accurate study records, regulatory documentation, and data management systems.
• Contribute to scientific writing, manuscript preparation, conference abstracts, and journal publications.
• Assist with Institutional Review Board (IRB) submissions, modifications, continuing reviews, and study amendments.
• Mentor undergraduate and graduate students involved in research activities.
• Develop and maintain study-related website and social media content to support participant recruitment and public engagement.
• Participate in research meetings, data analysis, dissemination activities, and other laboratory projects as needed.
• Independently conduct research including constructing hypotheses, designing and planning research studies, data management, model development, conducting experiments or assessments, analysis and interpretation of results, and evaluation of research techniques.
• Collaborate with internal and external stakeholders.
• Ensure compliance with institutional, sponsor, and regulatory requirements.
• Disseminate and publish research results in peer-reviewed journals, reports, meetings, workshops, and conferences.
• Assist in the writing of grant proposals.
• May assist in teaching classes.
• May assist in managing research laboratories.

Requirements

• PhD in biomedical engineering, public health, psychology, behavioral science, toxicology, epidemiology, engineering, health sciences, or a related discipline.
• Experience with human subjects research.
• Strong organizational and project management skills.
• Excellent written, verbal, and interpersonal communication skills.
• Demonstrated scientific writing ability.
• Basic proficiency with standard computer applications, spreadsheets, and data management tools.
• Ability to work independently while contributing effectively to a multidisciplinary research team.

Preferred Qualifications

• Experience coordinating or managing human subjects clinical trials.
• Experience with pharmacokinetic (PK) studies and biological sample collection, such as exhaled breath, urine, saliva, and blood.
• Strong record of peer-reviewed scientific publications.
• Experience conducting research involving tobacco products, nicotine delivery systems, or inhalation exposures.
• Current or previous CITI Human Subjects Research Training.
• Working knowledge of tobacco regulatory science and FDA tobacco product regulation.
• Experience with REDCap.

Skills

• Demonstrated ability to plan and execute research.
• Knowledge of applicable research methods and analytical procedures.
• Knowledge of research compliance and ethics.
• Knowledge of publishing/reporting requirements.
• Excellent teamwork and communication skills.
• Demonstrated potential for original or collaborative scholarship.
• Scientific writing skills demonstrated through peer-reviewed publications.
• Ability to acquire accurate, reproducible data.
• Critical eye towards consistency, reproducibility, and the scientific method.
• Excellent project and time management skills.
• Strong interpersonal and mentoring skills.
• Advocate for safety and ethics in the workplace.
• Ability to communicate findings and effectively work with sponsors and stakeholders.

Pay

$35,000.00 - $90,000.00 annual.

RIT considers factors such as (but not limited to) scope and responsibilities of the position, candidate’s work experience, education/training, key skills, internal peer equity, as well as market and organizational considerations when extending an offer.