The Research Quality Assurance Analyst reviews the requirements necessary for attaining and maintaining compliance with the FDA and other regulatory bodies for clinical trial research both from a documentation and process level. Promotes adherence to ICH-GCP guidelines by ensuring that data reported is accurate and complete and guarantees that the rights and safety of participants in clinical research are protected. This is accomplished by serving as a resource for the entire Office of Clinical Research (OCR) staff. Assists with pharmaceutical audit preparations and audit responses. Performs eligibility verifications and chart reviews. Research QA Analysts are an integral part of the infrastructure development and help to coordinate projects, and communicates status and improvement areas to leadership. May implement and coordinate department wide initiatives such as research quality management or clinical trial education efforts.
Bachelors Degree: Science or other health care discipline (Required)
Other : Graduate of an accredited school of nursing (Preferred)
Combination of relevant education and experience may be considered in lieu of degree.
Licenses and Certifications
CCRC - Cert Clin Research Coordinator (Preferred) or CCRA - Cert Clin Research Associate (Preferred)
CCRP - Cert Clin Research Prof (Preferred)
ACRP-CP - Assn Clin Res Prof - Cert Prof (Preferred)
RN-LIC - PA Registered Nurse License (Preferred)
LPN-LIC - PA Practical Nurse License (Preferred)
1 Year experience in a health care environment as a Clinical Research
Associate, Clinical Research Coordinator Clinical research Nurse or Medical
Chart Auditor (Required)
2 Years’ experience in clinical trials auditing (Preferred)
2 Years’ experience in oncology (Preferred)
Critical Thinking Skills
Customer Service Skills
Electronic Medical Records
General Clerical Skills
General Computer Skills
Microsoft Office Skills
Strong Communication Skills
Strong Interpersonal Skills
Complies with all Temple University Health System policies and procedures, and all applicable accreditation standards, laws and regulations, including those regarding patient confidentiality such as, but not limited to, Health Insurance Portability and Accountability Act of 1996, P. L. 104-191 ('HIPAA') and the rules and regulations implemented hereunder.
Adheres to and promotes Hospital Safety Standards and the Safety Management Plan.
Performs all job responsibilities in alignment with the core values, mission and vision of the organization.
Performs other duties as required and completes all job functions as per departmental policies and procedures.
Attends staff meetings and completes mandatory in-services and requirements and competency evaluations on time.
Maintains current knowledge in present areas of responsibility (i.e., self-education, attends ongoing educational programs).
Actively participates to move the team toward the completion of goals.
Makes procedural or process suggestions for achieving team goals or performing team functions; provides necessary resources or helps to remove obstacles to help the team accomplish its goals.
Listens to and fully involves others in team decisions and actions; values and uses individual's differences and talents.
Shares important or relevant information with the team.
Builds a positive team by offering assistance and support to co-workers, patients, vendors, and partners.
Puts success of team above own interests.
Actively participates in and/or chairs meetings and committees.
Assists in establishing processes and procedures for all Quality Assurance (QA) and Quality Control (QC) functions of the Office of Clinical Research (OCR) to include industry sponsored studies, investigator-initiated studies and cancer cooperative group trials.
Identifies areas of concern and/or assesses gaps through routine reviews.
Assists in developing policies/work instructions related to quality management.
Develops other processes or systems to support quality management core.
Assists the OCR as a Research Quality Assurance Analyst by conducting reviews in the following categories, NCTN/NCI Audit Preparations (APs),
Internal /Educational Reviews (IERs), Non-OCR Supported Investigator-Initiated Trial Monitoring Reviews, Eligibility Verifications (EVs).
Conducts routine, spot and for-cause quality assurance audits.
Lead or participate in agency inspections (preparation, conduct, and responses).
Schedule audits, prepare documents, oversee all logistics.
Using a risk based model or equivalent, assists with the identification and/or selection of trials to be reviewed.
Track the reviews of external site visits and provides reports on activity and findings.
Communicate any critical compliance risks noted from these activities to the Research Compliance Oversight Committee.
Local travel may be required for monitoring of affiliate/satellite sites.
Assists with orientation and training for OCR staff and research faculty as related to research quality measures.
Collaborates with the Research Educator on training seminars, organizes webinars or other training/education activities to improve quality onsite and at Partner sites.
Participates in required training and education programs.
Creates and maintains written and electronic documents.
Documents all procedures and activities timely, accurately, and legibly.
Follows all documentation standards according to department policy and procedures.
Generates and maintains quality management records, trackers and applicable reports.
Establishes effective documentation of audit and monitoring procedures for new and incumbent staff.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and Institutional Review Board (IRB).
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Planning and Organizing
Plans effectively to ensure that all work is completed accurately and efficiently.
Determines project/assignment requirements by breaking them down into tasks and identifying types of equipment, materials, and people needed; develops timelines and milestones.
Regularly reassesses priorities and competing demands and adjusts allocation of time and resources to increase efficiency and effectiveness.
Implements systems and processes that enable others to perform work independently.
Takes responsibility for own actions.
Strives to improve levels of individual, team and organizational performance.
Measures self against standard of excellence.
Participates in performance improvement efforts.
Demonstrates efficient and effective use of organizational resources as well as systems and services.
Explore new opportunities to add value to the organization and departmental processes.
Time Management and Planning
Uses time effectively to ensure that all work is completed accurately and efficiently.
Prioritizes activities and assignments; adjusts priorities when appropriate.
Allocates appropriate time and resources for completing work; develops timelines.
Uses peak and slow time periods effectively.
Resolves conflict in the workplace in a manner that is respectful for all individuals involved.
Uses sound judgment to determine when to request assistance to resolve conflict.
Listens openly to different opinions. Works to achieve win/win solutions.
To apply, please go to https://tuhs.taleo.net/careersection/tuhs_ex/jobdetail.ftl?job=222428&tz=GMT-04%3A00&tzname=America%2FNew_York