Clinical Research Manager

Clinical Research Manager -(STA015113)Clinical Research Manager

Organization

H0307 UH Population Health

Description

Position will be grant funded.

Oversees investigator-initiated and sponsored clinical research projects. Manages graduate students, post-doctoral fellows and Clinical Lab staff in providing complex administrative duties to support the study and ensure compliance with regulations.

• Manage advertising and recruitment of clinical research subjects within the clinic and the community; conduct phone interviews, answer questions regarding ongoing studies, screen, and consent and enroll study subjects.
• Track study recruitment, enrollment, drop out, and screen failure rates.
• Schedule study visits and provide visit reminders.
• Participate in site qualification / initiation / close-out and other study-specific training.
• Perform limited study procedures with appropriate training; including questionnaires, automated machinery and vision testing.
• Assist with preparation of all IRB and Regulatory documents including but not limited to trial registrations and sponsor reports.
• Maintain accurate source documentation and appropriate forms including participant records, drug documentation, reconciling study drug accountability;

monitors documentation for quality and accuracy.

• Ensure research studies are conducted in accordance with Good Clinical Practice (GCP) guidelines and requirements of the University of Houston and study sponsors.
• Maintain licensure and certification records for all study personnel.

Resolve data queries with study sponsors. Maintain supply inventory (general office and lab) and coordinate maintenance and calibration of equipment.

Establish effective, collaborative working relationships with clinicians, patients, and sponsors. Provide additional support and guidance for graduate students involved in research.

Performs other job-related duties as required.

EEO / AA

Summary

UH Population Health is seeking a Clinical and Translational Science Manager to assist in the management and implementation of sponsored clinical and translational science.

This role will serve as the operational Program Manager to support multi-departmental efforts.

• Assists with the establishment and management of a clinical and translational science infrastructure. (AD)
• Assist with the preparation of IRB and regulatory documents, including but not limited to trial registrations and sponsor reports.
• Assist with the management of pilot grant applications, review, funding, follow-up, progress reports to the funder, and close-outs. (AD)
• Maintains accurate source documentation and appropriate forms, and monitors documentation for quality and accuracy. (M)
• Ensue research studies are conducted in accordance with Good Clinical Practice (GCP) guidelines and requirements by the University of Houston and study sponsors.
• Maintain licensure and certification records for staff and study personnel. (M)
• Establish effective, collaborative working relationships with researchers, clinicians, patients, staff, and sponsors. (M)
• Tracks program milestones, which includes stakeholders across multiple departments across UH. (AD)
• Prepare operational workplans, utilization reports, and plans for required resources across functional areas based on scope and schedule. (AD)
• Identify opportunities for improvement to execution of processes and tools. (AD)
• Create project schedules and maintain them through the project lifecycle. (AD)
• Facilitate communication with collaborators and maintain relationships in a proactive fashion. (AD)
• Coordinate logistics and contribute to contract execution with relevant partners. (AD)

Qualifications

Position will be grant funded.

Bachelors and 5 years experience

Requires a thorough understanding of both theoretical and practical aspects of an analytical, technical or professional discipline;

or the basic knowledge of more than one professional discipline. Knowledge of the discipline is normally obtained through a formal, directly job-related 4 year degree from a college or university or an equivalent in-depth specialized training program that is directly Requires a minimum of five (5) year of directly job-related experience.