Research Coordinator II - CAGT

We are seeking a highly motivated Research Coordinator to support innovative clinical and translational research programs focused on cell and gene therapy. The Research Coordinator will manage day-to-day study operations, including participant recruitment, informed consent, protocol implementation, regulatory compliance, data collection, and coordination with multidisciplinary teams. The ideal candidate will work closely with physicians, scientists, industry sponsors, and regulatory agencies to ensure the successful execution of complex clinical trials involving advanced therapeutic products. Strong organizational skills, attention to detail, and experience in clinical research are essential. This position offers the opportunity to contribute to groundbreaking therapies that have the potential to transform the treatment of cancer, genetic disorders, and other serious diseases. FLSA STATUS
Exempt

QUALIFICATIONS

EDUCATION

• Bachelor’s degree

EXPERIENCE

• Four years of research experience

LICENSES AND CERTIFICATIONS
Preferred

• CCRC - Certified Clinical Research Coordinator (ACRP) or
• CCRP - Certified Clinical Research Professional (SOCRA)

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
• Ability to work independently
• Capable of handling challenging/difficult situations
• Demonstrates sound judgment and executes above average analytical skills

ESSENTIAL FUNCTIONS

PEOPLE ESSENTIAL FUNCTIONS

• Under the direction of the Principal Investigator (PI), drafts various communications with the Sponsor and/or regulatory documents to be sent to the Sponsor.
• Identifies and recruits clinical research subjects and monitors enrollment goals.
• May conduct in-services to floor nurses/physicians; assists in precepting new clinical research staff and educating other research staff regarding scientific aspects of studies.
• Teaches peers to critically think by verbally expressing rationale for decisions and follows up consistently. Uses peer-to-peer accountability towards improvement of department score for turnover/retention/employee engagement.

SERVICE ESSENTIAL FUNCTIONS

• Participates in the Principal Investigator (PI) meetings.
• Schedules, coordinates, and participates in the pre-site visit and site initiation visits; coordinates study initiation. Obtains Informed Consent from study participant and documents appropriately.
• Obtains vital signs and performs phlebotomy per training and competence; monitors participants’ labs and notifies the PI of laboratory findings.

QUALITY/SAFETY ESSENTIAL FUNCTIONS

• Prepares Institutional Research Board (IRB) documents under the direction of the PI, assists with answering IRB stipulations to obtain final approval; documents IRB approval and contract approval.
• Maintains and monitors source documentation and appropriate forms as per protocol for quality and accuracy, including participant records; assists with the quality assurance process. Adheres to internal controls established for the department.

FINANCE ESSENTIAL FUNCTIONS

• Assists with the budget development and Medicare coverage analysis.
• Utilizes resources effectively and efficiently, demonstrating responsible financial stewardship. Manages own time effectively and prioritizes work to achieve maximum results in a timely manner.

GROWTH/INNOVATION ESSENTIAL FUNCTIONS

• Assists PI and/or research nurse in the planning and design of source documents for protocol.
• Assists in developing procedures for laboratory collection and storage.
• Incorporates directions from other health care disciplines into clinical research protocols when reviewing patient eligibility; assists in eliciting relevant data from sources outside of the hospital.
• Proactively manages own professional development and completes My Development Plan.

SUPPLEMENTAL REQUIREMENTS

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

Work Shift:

1 - Day (United States of America)

Job Category:

Non-clinical Houston Methodist is one of the nation’s leading health systems and academic medical centers. The health system consists of eight hospitals: Houston Methodist Hospital, its flagship academic hospital in the Texas Medical Center, seven community hospitals and one long-term acute care hospital throughout the Greater Houston metropolitan area. Houston Methodist also includes a research institute; a comprehensive residency program; international patient services; freestanding comprehensive care clinics, emergency care and imaging centers; and outpatient facilities. Come lead with us!

Houston Methodist is an Equal Opportunity Employer.