Über
FLSA STATUS
Exempt
QUALIFICATIONS
EDUCATION
Bachelor's degree in life sciences or related field from an accredited college or university
EXPERIENCE
Three years Clinical Trial Coordinator or equivalent experience
Quality Assurance/Regulatory Compliance experience within an FDA regulated industry, preferably devices, diagnostics or pharmaceuticals desirable
Regulatory audit exposure with US-FDA preferred
LICENSES AND CERTIFICATIONS
Required
Must have one of the following certifications: CCRP, CCRA, CCRC, ACRP-CP within 1 year
Preferred
Certification in Quality Auditing or Quality Assurance
KNOWLEDGE 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
Excellent working knowledge of FDA regulations and GCP guidelines
Excellent written and oral communication skills
Excellent working knowledge of the clinical trial operations
Ability to develop Quality Assurance strategy and implementation
Ability to identify and/or resolve quality issues/discrepancies with others in a proactive diplomatic, flexible, and constructive manner
Ability to work in a team environment with effective leadership skills
ESSENTIAL FUNCTIONS
PEOPLE ESSENTIAL FUNCTIONS
Assists institutional investigators and other members of the research team, by providing education and training regarding processes and procedures governing clinical research activities which can be ad-hoc, remote/teleconferences, or face-to-face sessions with the entire research team.
Partners with specific research teams to identify potential changes and opportunities for improvement, within department and/or study-specific SOPs, policies, training materials, and other documents, as needed.
Promotes a positive work environment and contributes to a dynamic, team-focused work unit that actively helps one another to achieve optimal department results. Encourages interdepartmental, as well as institution-wide communication, as it relates to clinical research studies.
Contributes towards improvement of department scores for employee engagement, i.e. peer-to-peer accountability.
SERVICE ESSENTIAL FUNCTIONS
Educates and mentors research team with interpretation of regulatory requirements, e.g., GCPs, SOP requirements, and other guidance documents, as applicable.
Assists other Research Protections staff, as needed, including IRB, IBC, RSC, and HSC. Provides timely feedback to stakeholders to facilitate swift and efficient process improvement.
Evaluates site readiness based on HMRI standards prior to start date of a new clinical trial.
QUALITY/SAFETY ESSENTIAL FUNCTIONS
Conducts feasibility assessments, ongoing quality assurance reviews of clinical research studies, with the goal of assessing site readiness. Develops site-specific education and processes within specified research teams.
Coordinates monthly Clinical Research Education Series, the Clinical Research Orientation Program (CROP), and the annual Clinical Research Conference.
Meets regularly with the clinical trial manager(s) and Principal Investigators (PIs) to discuss quality/compliance trends.
Monitors and evaluates ongoing quality and compliance standards, along with regulatory and clinical trial trends/actions, with regular reports to QA management. Assists with preparation and/or assists during regulatory inspections.
FINANCE ESSENTIAL FUNCTIONS
Identifies cost saving initiatives within the department and communicates recommendations to Sr Quality Assurance Analyst and/or management.
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
Analyzes responses to monitoring and audit reports; collaborates with the research team to follow-up with respondents, management, or others, if needed, to ensure resolution.
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.
SUPPLEMENTAL REQUIREMENTS
WORK ATTIRE
Uniform: No
Scrubs: No
Business professional: Yes
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 Yes
May require travel outside Houston Metropolitan area No
QUALIFICATIONS
EDUCATION
Bachelor's degree in life sciences or related field from an accredited college or university
EXPERIENCE
Three years Clinical Trial Coordinator or equivalent experience
Quality Assurance/Regulatory Compliance experience within an FDA regulated industry, preferably devices, diagnostics or pharmaceuticals desirable
Regulatory audit exposure with US-FDA preferred
LICENSES AND CERTIFICATIONS
Required
Must have one of the following certifications: CCRP, CCRA, CCRC, ACRP-CP within 1 year
Preferred
Certification in Quality Auditing or Quality Assurance
Company Profile:
Houston Methodist Academic Institute oversees the Education Institute and Research Institute. 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 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 clinical research protocols and extramurally funded translational research programs.
Houston Methodist is an Equal Opportunity Employer.
Sprachkenntnisse
- English
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