Clinical Research Specialist, Pediatric Critical Care

PED-CRITICAL CARE MEDICINE (IN-PICU-IUINA) Department‑Specific Responsibilities

• Supports the execution and management of clinical research studies or trials.
• Assists in identifying and recruiting potential research participants, evaluates eligibility based on institutional review board (IRB) and protocol‑approved methodologies, coordinates study procedures, and monitors the progress of research projects.
• Records study data, samples, and results in various databases; maintains databases related to subjects and scheduling; and prepares reports on study data as needed.
• Serves as the primary contact for assigned trials at parent study sites; manages the start‑up and maintenance of regulatory aspects, prepares study progress reports, maintains staff training records, conducts monitor visits/audits, and tracks invoicing for completed subjects in coordination with the research administrator.
• Identifies and recruits potential research participants for assigned trials, evaluates eligibility based on IRB and protocol‑approved methodologies, coordinates study procedures, monitors the progress of research projects, and records study data, samples, and results across various databases.
• Provides laboratory management for assigned trials, including translational sample processing/shipment, and ensures essential lab materials remain accessible to the team.

• Assists with identifying and recruiting potential research study subjects; determines eligibility according to the IRB/protocol approved methodologies, coordinates study procedures, and monitors the progress of research studies or projects.
• Conducts study visit activities and coordinates screening, consenting, and scheduling of tests, exams, and/or non‑medical/behavioral interventions and assessments involving study subjects. Coordinates, facilitates, and performs various study activities; manages all follow‑up activities with subjects based on protocols.
• Records study data, samples, and/or results in various databases. Maintains databases for subjects and subject scheduling. Performs data validation checks and pursues resolutions to erroneous data. Produces various reports in response to requests from principal investigator (PI), sub‑investigators, and/or other study stakeholders.
• Monitors study team compliance with protocol and standard operating procedures (SOPs). Submits all regulatory paperwork required. Communicates with PI and sub‑investigators about concerns or recommended changes in study protocols, etc.
• Assists with developing various communications and strategies for advertising and recruitment, as well as in developing information materials for study participants.
• Stays up to date on regulatory affairs and/or clinical research best practices by attending continuing education classes, conferences, seminars, and project team meetings.
• Provides various other clinical research study or project support as needed (such as assisting with budget development, invoicing for adverse events, billing compliance and patient billing resolution).
• May provide guidance and/or support to less experienced clinical research staff.

Combinations of related education and experience may be considered. Education beyond the minimum required may be substituted for work experience. Work experience beyond the minimum required may be substituted for education.

• Bachelor's degree in science or a health‑related field and 1 year of health‑related or research experience; OR
• Associate's degree in an allied health profession and 3 years of health‑related or research experience.

• Proficient written and verbal communication skills.
• Maintains a high degree of professionalism.
• Demonstrates time management and priority setting skills.
• Demonstrates a high commitment to quality.
• Possesses flexibility to work in a fast paced, dynamic environment.
• Highly thorough and dependable.
• Possesses a high degree of initiative.
• Ability to build strong customer relationships.

The role regularly requires the ability to effectively communicate. The role frequently requires the ability to move about the work environment and to position oneself to operate…