Clinical Research Specialist - UH Health Clinical Trials Office

Overview

The Clinical Trials Specialist is a professional-level position responsible for the independent management and oversight of complex, multi-site, investigator-initiated, federally funded, and industry-sponsored clinical trials conducted within an academic medical center environment. Under general supervision, the Clinical Research Specialist assists with study operations, participant coordination, regulatory documentation, and data management activities in support of federally funded, industry-sponsored, and investigator-initiated clinical trials.

This position is designed for individuals who possess strong analytical, organizational, and communication skills and who demonstrate the ability to work effectively in a highly regulated healthcare and academic environment. The role requires the capacity to learn and apply federal regulations, institutional policies, and Good Clinical Practice (GCP) standards governing human subjects research. The position is expected to exercise a high degree of independent judgment, provide operational leadership for assigned studies, and ensure adherence to all federal, state, sponsor, and institutional requirements governing human subjects research.

• Independently manage all phases of complex clinical trials, including study startup, activation, enrollment, maintenance, monitoring, and closeout activities.
• Coordinate multi-disciplinary research activities involving investigators, pharmacy, laboratory services, nursing, finance, data management, and external sponsors or CROs.
• Interpret and operationalize highly technical research protocols and develop study workflows to ensure protocol fidelity and regulatory compliance.
• Work with Regulatory Department for regulatory submission activities, including Institutional Review Board (IRB) applications, continuing reviews, amendments, safety reporting, and responses to regulatory findings.
• Ensure compliance with FDA regulations, ICH-GCP guidelines, HIPAA requirements, NIH policies, and institutional standards governing clinical research.
• Oversee participant recruitment, screening, informed consent, and retention strategies for complex therapeutic trials.
• Evaluate and resolve protocol deviations, data discrepancies, eligibility concerns, and adverse event reporting requirements.
• Prepare for and facilitate sponsor monitoring visits, internal audits, and FDA inspections.
• Maintain accountability for data quality, source documentation integrity, investigational product accountability, and timely case report form completion.
• Work closely with the finance department to ensure proper billing and patient charge segregation.
• Utilize clinical trial management systems, electronic data capture systems, and electronic medical records to support research operations and reporting.
• Participate in departmental committees, investigator meetings, feasibility assessments, and strategic research planning initiatives.

Employees must be in a regular position, working 20 hours or more per week (.50 FTE or greater) to qualify for benefits.

• Bachelor's Degree in allied health, nursing, or a related field and 2 years of clinical research or directly related experience Required
• Experience may substitute on a year-for-year basis for the required education Preferred

Knowledge, Skills, and Abilities

• Excellent written and verbal communication skills and interpersonal relationship skills (High proficiency)
• Excellent problem-solving and critical thinking skills (High proficiency)
• Ability to manage confidential information with discretion (High proficiency)
• Ability to interact professionally with all organizational levels (High proficiency)
• Ability to manage competing priorities in a fast paced environment (High proficiency)
• Ability to build productive internal/external working relationships (High proficiency)
• Directly related experience will substitute for the required education
• Advanced knowledge of and work experience with federal and state regulations, GCP guidelines, HIPAA, institutional policies, and SOPs (Low proficiency)
• Proficient knowledge of FDA clinical research guidelines and all phases of the research process required (Low proficiency)
• Good computer skills in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file) preferred (Medium proficiency)
• Ability to work with a continued focus on quality, efficiency and ongoing improvement through decision making, planning and organizational skills, communication and quality orientation (High proficiency)
• Commitment to teamwork, excellent organizational and prioritizing capabilities and skills (High proficiency)
• Excellent interpersonal skills, detailed-oriented and meticulous (High proficiency)