Clinical Research Associate

At Houston Methodist, the Clinical Research Associate position is responsible for performing clinical research experiments and projects of a complex nature under the supervision/direction of a Principal Investigator. The Clinical Research Associate will drive multiple clinical research projects/trials and/or for multiple Principal Investigators (PI), gathering patient data via methods specified in the study protocol and providing general administrative duties in support of the study. This position serves as a liaison between physicians, patients, staff, and sponsors.

FLSA STATUS
Exempt

QUALIFICATIONS

EDUCATION

• Doctor of Medicine (MD) from an accredited medical school, Pharm D or Doctoral degree (PhD) in medical field

EXPERIENCE

• 5 years of related experience in a Research / Healthcare setting required

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
• Adapts to multiple ongoing priorities with minimal supervision including, organizing workflow, and actively participating in problem-solving
• 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
• Demonstrates sound judgment and executes above-average analytical skills
• Exhibits strong interpersonal, teamwork, and leadership skills with all levels of the healthcare team and assures delivery of excellent customer service to all patients, visitors, physicians, and co-workers

ESSENTIAL FUNCTIONS

PEOPLE ESSENTIAL FUNCTIONS

• Assists PI/faculty by supporting junior staff in research and scientific activities. Provides communication of needs, issues to be addressed, and all important information necessary to ensure scientific success.
• Role models excellent, clear, and professional communication skills to achieve mutual understanding and problem resolution. Collaborates with all members of the research team by actively communicating and reporting pertinent information as it relates to an assigned system(s) in a comprehensive manner.
• Contributes to a positive work environment and contributes to a dynamic, team-focused work unit that actively helps one other to achieve optimal department results.
• Contributes recommendations for initiatives to improve department scores for employee engagement.

SERVICE ESSENTIAL FUNCTIONS

• Participates in the Principal Investigator (PI) meetings and in-services for study implementation.
• Collects and processes study data and maintains study databases in accordance with study protocols. Develops and conducts statistical analyses for interventional and observational studies using relevant statistical software. Perform data abstraction, collection, and entry to support clinical research.
• Screens potential study participants through medical record reviews, interviews, and follow-ups with healthcare provider.
• Serves as liaison between team members, management, and PIs, resolving more complex matters for the area.

QUALITY/SAFETY ESSENTIAL FUNCTIONS

• Ensures quality is maintained for Research Protocols.
• Oversees and maintains accurate source documentation and appropriate forms as per protocol including participant records, drug documentation, reconciling study drug/device accountability; monitors documentation for quality and accuracy.
• Collaborates and prepares with Principal Investigator, Institutional Review Board (IRB), and regulatory documents for submission assuring compliance with local and federal regulatory standards as appropriate and required by the research protocol. Follows International Council for Harmonization/Good Clinical Practice guidelines.

FINANCE ESSENTIAL FUNCTIONS

• Uses resources efficiently; does not waste supplies. Self-motivated to independently manage time effectively and prioritize daily tasks.
• Assists with identifying, recruiting, and consenting clinical research subjects for participation in approved clinical trials; monitors enrollment goals and modifies enrollment strategies, as necessary.

GROWTH/INNOVATION ESSENTIAL FUNCTIONS

• Assists with developing skills of a study/lab team (staff and students) in alignment with scientific and research objectives.
• Plans and designs source documentation for protocol. Develops study-specific forms or tools per protocol to use in clinical research and teaches the research team how to use the assessment tool.
• Participates in conferences and seminars. Proactively manages own professional development and completes My Development Plan.

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 No
• May require travel outside Houston Metropolitan area No

QUALIFICATIONS

EDUCATION

• Doctor of Medicine (MD) from an accredited medical school, Pharm D or Doctoral degree (PhD) in medical field

EXPERIENCE

• 5 years of related experience in a Research / Healthcare setting required