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.
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.
- Bachelor’s degree in health science-related field
- Master’s degree preferred
- Two years’ experience in healthcare setting
- Research setting preferred
CERTIFICATIONS, LICENSES AND REGISTRATIONS REQUIRED
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
Work Attire Yes/No
Business professional Yes
Other (dept approved) No
*Note that employees may be required to be on-call during emergencies (ie. Disaster, Severe Weather Event, etc) regardless of selection above.
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
A cornerstone of Houston Methodist's strategic vision as a source for leading care, Houston Methodist Academic Institute conducts ground breaking translational and clinical research to provide the best care to patients in our community and around the world. At Houston Methodist, fostering innovations with the potential for clinical application is at the very heart of what we do. Our interdisciplinary teams of clinicians and researchers are committed to streamlining the process of translating discoveries into treatments and cures for our patients.
At Houston Methodist, Leading Medicine is more than a description of what we do; it's who we are. We take our responsibility as Houston's premier health care system seriously, and with a national reputation for excellence in patient care, innovation and research, we hold ourselves and the careers we build to a higher standard. Our culture is diverse, dynamic and challenging. We believe in our I Care Values and conduct ourselves with Integrity, Compassion, Accountability, Respect for others and a commitment to Excellence. Discover the difference for yourself and join Houston Methodist.
You can click on the video links below to learn more!
· About Houston Methodist: https://www.youtube.com/watch?v=ClN3mmKT0EI
· Nursing at Houston Methodist: https://www.youtube.com/watch?v=EUfmVeansTo
· Houston - Best City to Live In: https://www.youtube.com/watch?v=MzLQzGBjHJw