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Houston Methodist Clinical Research Specialist in Houston, Texas

At Houston Methodist, under supervision of the Clinical Trials Manager, the Clinical Research Specialist is responsible for supporting multiple projects which may include clinical research protocols, gathering patient data via methods specified in the study protocol, providing scientific writing to include protocol development, study reports, grant writing and manuscript development. This position ensures accurate data collection, documentation organization, and safety of study volunteers.

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.

  • Focuses on patient/customer safety

  • 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 rounds with patients/customers to ensure their needs are being met

  • 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 vision, fulfills the mission and abides by the I CARE values

PRIMARY JOB RESPONSIBILITIES

Job responsibilities labeled EF capture those duties that are essential functions of the job.

PEOPLE - 20%

  • Supports the interprofessional 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. (EF)

  • Teaches peers to critically think by verbally expressing rationale for decisions. Facilitates open, professional, communication to achieve mutual understanding, role modeling by example and coaches staff in effective verbal, non-verbal and written communication. (EF)

  • 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. (EF)

SERVICE - 30%

  • 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. (EF)

  • Organizes the workflow, proactively problem solves, anticipates needs, and manages multiple ongoing priorities. Provides communication of needs, issues to be addressed, and all-important information necessary to ensure department success. (EF)

  • Makes phone calls to study patients for appointment reminders and follow-up. (EF)

  • Transports blood and tissue samples. Processes and packages lab samples for shipping to sponsor or storage at site per the study manual of operations. (EF)

QUALITY/SAFETY - 20%

  • Completes required case report forms and resolves all outstanding queries. Coordinates study procedures for study assessments and schedules baseline and follow up assessments with participants. Ensures accurate data collection, documentation organization, and safety of study volunteers. Ensures accurate regulatory filing. (EF)

  • Assists Clinical Trial Manager in identifying opportunities for corrective action and research work flow process improvement, providing recommendations, and contributes to meeting department and hospital targets for quality and safety. Assists with the implementation and education of department-based safety initiatives and standards of practice. (EF)

FINANCE - 15%

  • Assures study conduct meets appropriate IRB, FDA, ICH and agency guidelines. Extracts, reviews, compiles and analyzes patient financial data and medical records. (EF)

  • Provides scientific writing to include protocol development, study reports, grant writing and manuscript development. (EF)

  • 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. (EF)

GROWTH/INNOVATION - 15%

  • Assist in simple data analysis, with development of training materials for data reports, systems and collection and report generation. (EF)

  • Leads and identifies opportunities for practice changes and performance improvement. Investigates and incorporates evidence-based practices with input leadership when appropriate. Supports change initiatives and adapts to unexpected changes. (EF)

  • 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. (EF)

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 REQUIREMENTS

  • Bachelor’s degree in health science-related field

  • Master’s degree preferred

EXPERIENCE REQUIREMENTS

  • Two years’ experience in healthcare setting

  • Research setting preferred

CERTIFICATIONS, LICENSES AND REGISTRATIONS REQUIRED

  • None

KNOWLEDGE, SKILLS AND ABILITIES REQUIRED.

  • 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

  • Ability to analyze complex clinical and research data

  • Ability to interpret compliance requirements

  • Responsible for complex research project management involving physicians, patients alongside research team members

  • Exhibits good listening skills

  • Ability to work independently and analyze and solve problems

  • Demonstrates the ability to manage complex 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 Yes/No

Uniform No

Scrubs Yes

Business professional Yes

Other (dept approved) No

On-Call* No

*Note that employees may be required to be on-call during emergencies (ie. Disaster, Severe Weather Event, etc) regardless of selection above.

Travel**

May require travel within Yes

Houston Metropolitan area

May require travel outside No

of Houston Metropolitan area

**Travel specifications may vary by department.

Please note any other special considerations to this job: Some assignments may be in hospital units (including laboratory) with typical hospital environmental hazards and concerns

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.

Street: 6670 Bertner Ave

Name: Structural Heart Dis_Interv

Regular Shift: 1st - Day

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