Clinical Research Specialist - HCR Clinical Admin
Houston, TX, United States
At Houston Methodist, the Clinical Research Specialist position is responsible for supporting multiple projects under supervision of Clinical Trials Manager which may include clinical research protocols, gathering patient data via methods specified in the study protocol, study reports. This position ensures accurate data collection, documentation organization, and safety of study volunteers. This position has a strong emphasis on regulatory work with Houston Methodist’s local IRB and external IRBs. An essential fuction of the role is: Performing protocol continuing reviews with local or external IRBs, protocol and/or informed consent form modifications, and assisting Clinical Trials Manager and coordination team with startups and ongoing studies
PEOPLE ESSENTIAL FUNCTIONS
Supports the inter-professional team of clinical research investigators, nurses and coordinators. Promotes a positive work environment and contributes to a dynamic, team-focused work unit that actively helps one other to achieve optimal department results.
Conducts self in a manner that is congruent with cultural diversity, equity and inclusion principles. Contributes towards improvement of department scores for employee engagement, i.e. peer-to-peer accountability
SERVICE ESSENTIAL FUNCTIONS
Performs clinical research support functions as assigned by the clinical trial manager including but not limited to informed consent for non-interventional studies, data abstraction and recording in CRFs
Makes phone calls to study patients for appointment reminders and follow-up
Transports blood and tissue samples. Processes and packages lab samples for shipping to sponsor or storage at site per the study manual of operations.
QUALITY/SAFETY ESSENTIAL FUNCTIONS
Completes required case report forms and resolves queries. Ensures accurate data collection, documentation organization, and safety of study volunteers. Ensures accurate regulatory filing
Assists Clinical Trial Manager in identifying opportunities research work flow process improvement, providing recommendations, and contributes to meeting department and hospital targets for quality and safety
FINANCE ESSENTIAL FUNCTIONS
Assures study conduct meets appropriate IRB, FDA, ICH and agency guidelines
Utilizes resources with cost effectiveness and value creation in mind. Self-motivated to independently manage time effectively and prioritize daily tasks, assisting coworkers as needed
GROWTH/INNOVATION ESSENTIAL FUNCTIONS
Assist in simple data analysis, with development of training materials for data reports, systems and collection and report generation
Leads and identifies opportunities for performance improvement. Supports change initiatives and adapts to unexpected changes
Seeks opportunities to identify self-development needs and takes appropriate action. Ensures own career discussions occur with appropriate management. Completes and updates the My Development Plan on an on-going basis
This job description is not intended to be all-inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises.
EDUCATION
Bachelor's degree in health science-related field
WORK EXPERIENCE
One year experience in healthcare setting preferred
Research setting preferred
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