Clinical Research Specialist

Overview

At Houston Methodist, the Clinical Research Specialist position is responsible for supporting multiple projects under supervision of Clinical Trial 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.

Houston Methodist Standard

PATIENT AGE GROUP(S) AND POPULATION(S) SERVEDRefer to departmental "Scope of Service" and "Provision of Care" plans, as applicable, for description of primary age groups and populations served by this job for the respective HM entity.

HOUSTON METHODIST EXPERIENCE EXPECTATIONS

• Provide personalized care and service by consistently demonstrating our I CARE values:
  • INTEGRITY: We are honest and ethical in all we say and do.
  • COMPASSION: We embrace the whole person including emotional, ethical, physical, and spiritual needs.
  • ACCOUNTABILITY: We hold ourselves accountable for all our actions.
  • RESPECT: We treat every individual as a person of worth, dignity, and value.
  • EXCELLENCE: We strive to be the best at what we do and a model for others to emulate.

• Practices the Caring and Serving Model

• Delivers personalized service using HM Service Standards

• Provides for exceptional patient/customer experiences by following our Standards of Practice of always using Positive Language (AIDET, Managing Up, Key Words)

• Intentionally collaborates with other healthcare professionals involved in patients/customers or employees' experiential journeys to ensure strong communication, ease of access to information, and a seamless experience

• Involves patients (customers) in shift/handoff reports by enabling their participation in their plan of care as applicable to the given job

• Actively supports the organization's vision, fulfills the mission and abides by the I CARE values

Responsibilities

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.

• 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 workflow 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.

Qualifications

EDUCATION

• Bachelor's degree in a related field

• Bachelor's Degree in a Health-Science related field preferred

WORK EXPERIEN