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

PATIENT AGE GROUP(S) AND POPULATION(S) SERVED
Refer 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

• Displays cultural humility, diversity, equity and inclusion principles

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

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

LICENSES AND CERTIFICATIONS - REQUIRED

• N/A

KNOWLEDGE, SKILLS, AND ABILITIES

• Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations

• Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security

• Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles

• Exhibits good listening skills

• Ability to work independently and analyze and solve problems

• Demonstrates the ability to manage clinical and interpersonal situations

• Able to prioritize tasks and manage multiple projects

• Self-motivated with the ability to think critically and work independently

SUPPLEMENTAL REQUIREMENTS

WORK ATTIRE

• Uniform No
• Scrubs Yes
• Business professional Yes
• Other (department approved) No

ON-CALL*
*Note that employees may be required to be on-call during emergencies (ie. DIsaster, Severe Weather Events, etc) regardless of selection below.

• On Call* No

TRAVEL**
**Travel specifications may vary by department**

• May require travel within the Houston Metropolitan area Yes
• May require travel outside Houston Metropolitan area No

Houston Methodist Research Institute was formed in 2004 to rapidly and efficiently translate discoveries made in the laboratory and the clinic into new diagnostics, therapies, and treatments. The research institute was created to provide the infrastructure and support for these endeavors, and to house the technology and resources needed to make innovative breakthroughs in important areas of human disease. A 540,000 square foot building dedicated to research, the research institute houses over 1,500 staff and trainees, 284 principal investigators and has more than 570 ongoing clinical trials.