Research Quality Control Associate

San Antonio, TX - USA

Monthly Salary: Not Disclosed

Posted on: 8 hours ago

Vacancies: 1 Vacancy

Job Summary

JOB SUMMARY

As Research Quality Control Associate you will be responsible for clinical monitoring activities involving Quality Control (QC) and compliance including applicable regulatory requirements and reviewing existing research projects under the direction of Research leadership.

DUTIES AND ESSENTIAL JOB FUNCTIONS:

Conduct internal quality control activities as an internal monitor to ensure protocol compliance data accuracy and patient safety in compliance with Sponsor protocols Good Clinical Practices (GCPs) standard operating procedures (SOPs) and applicable agency regulations
Report findings to QC and Research leadership and coordinate approved action items for process improvement
Collaborate with cross-functional teams to ensure timely completion of study milestones and deliverables
Contribute to the preparation of Quality reports and presentations for internal stakeholders
Assist the research staff in preparation of sponsors audits and Food and Drug Administration inspections
May assist with Corrective and Preventive Action (CAPA) plan resolutions as needed
Stay current with developments in clinical research regulations guidelines and industry best practices
Perform other related duties as assigned

Other Functions and Responsibilities

This job description does not cover or contain a comprehensive listing of the employees activities duties or responsibilities for this addition duties responsibilities and activities may change at any time with or without notice.

COMPETENCIES

Ethical Conduct
Flexibility
Initiative
Personal Effectiveness/Credibility
Stress Management/Composure

Requirements:

Bachelors degree in life sciences or related field required
Minimum 3 years of progressive experience in research management monitoring and/or quality required
Certification in clinical research (e.g. ACRP or SOCRA) is preferred
Valid drivers license and insured automobile required
Additional knowledge and skills:
- Knowledge of research methods and procedures sufficient to compile data and prepare reports
- Knowledge of confidentiality requirements related to patient information
- Knowledge of Good Clinical Practice (GCP) guidelines and other relevant regulatory requirements
- Ability to learn and proficiently utilize diverse eCRF systems electronic regulatory management systems Electronic Medical Record systems (EMR).
- Readiness to adapt new technology
- Willingness to travel on-site as needed

QUALIFICATIONS:

Quality assurance/control: 4 years (Required)
FDA regulations: 4 years (Required)

Required Experience:

JOB SUMMARYAs Research Quality Control Associate you will be responsible for clinical monitoring activities involving Quality Control (QC) and compliance including applicable regulatory requirements and reviewing existing research projects under the direction of Research leadership. DUTIES AND ESSEN...

JOB SUMMARY

DUTIES AND ESSENTIAL JOB FUNCTIONS:

Conduct internal quality control activities as an internal monitor to ensure protocol compliance data accuracy and patient safety in compliance with Sponsor protocols Good Clinical Practices (GCPs) standard operating procedures (SOPs) and applicable agency regulations
Report findings to QC and Research leadership and coordinate approved action items for process improvement
Collaborate with cross-functional teams to ensure timely completion of study milestones and deliverables
Contribute to the preparation of Quality reports and presentations for internal stakeholders
Assist the research staff in preparation of sponsors audits and Food and Drug Administration inspections
May assist with Corrective and Preventive Action (CAPA) plan resolutions as needed
Stay current with developments in clinical research regulations guidelines and industry best practices
Perform other related duties as assigned

Other Functions and Responsibilities

COMPETENCIES

Ethical Conduct
Flexibility
Initiative
Personal Effectiveness/Credibility
Stress Management/Composure

Requirements:

Bachelors degree in life sciences or related field required
Minimum 3 years of progressive experience in research management monitoring and/or quality required
Certification in clinical research (e.g. ACRP or SOCRA) is preferred
Valid drivers license and insured automobile required
Additional knowledge and skills:
- Knowledge of research methods and procedures sufficient to compile data and prepare reports
- Knowledge of confidentiality requirements related to patient information
- Knowledge of Good Clinical Practice (GCP) guidelines and other relevant regulatory requirements
- Ability to learn and proficiently utilize diverse eCRF systems electronic regulatory management systems Electronic Medical Record systems (EMR).
- Readiness to adapt new technology
- Willingness to travel on-site as needed