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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

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

Company Profile:

Houston Methodist Academic Institute oversees the Education Institute and Research Institute, including 772 faculty and 56,250 learners. The Academic Institute aligns our research and education initiatives in service to the clinical mission, providing solutions that answer the call for new technologies and skills our clinicians need for patient care.

Houston Methodist Education Institute coordinates our primary academic affiliation with Weill Cornell Medicine and other joint programs, including the Engineering Medicine Program at Texas A&M University Intercollegiate School of Engineering Medicine. The Education Institute also oversees continuing medical education and graduate medical education, and supports more than 1,000 trainees in residence for medical, nursing, allied health and research education programs.

Houston Methodist Research Institute supports research programs and infrastructure that enable faculty across the system to bring new scientific discoveries to patients as rapidly as possible through the full cycle of a cure from conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research Institute supports more than 1,387 clinical research protocols and $70.3 million in extramurally funded translational research programs.

Houston Methodist is an equal opportunity employer inclusive of women, minorities, disabled persons and veterans.

Equal Employment Opportunity

Houston Methodist is an Equal Opportunity Employer.

Equal employment opportunity is a sound and just concept to which Houston Methodist is firmly bound. Houston Methodist will not engage in discrimination against or harassment of any person employed or seeking employment with Houston Methodist on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, status as a protected veteran or other characteristics protected by law. VEVRAA Federal Contractor – priority referral Protected Veterans requested.

Houston Methodist is an Equal Opportunity Employer.

Equal employment opportunity is a sound and just concept to which Houston Methodist is firmly bound. Houston Methodist will not engage in discrimination against or harassment of any person employed or seeking employment with Houston Methodist on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, status as a protected veteran or other characteristics protected by law. VEVRAA Federal Contractor – priority referral Protected Veterans requested.