Research Quality Assurance Manager

Indiana Hemophilia & Thrombosis Center•Indianapolis, IN

27d•Hybrid

About The Position

The Research Quality Assurance (QA) Manager is responsible for the creation, implementation, and maintenance of a clinical research quality management system in conjunction with IHI CEO and Medical Director and IHI Chief Clinical Officer. This role involves evaluations of existing studies through auditing, review and oversight of training programs for new and existing research staff in collaboration with the Research Education Coordinator, ongoing maintenance and development of QA Standard Operating Procedures (SOPs), and review of other functional area SOPs relating to clinical research activities. The manager will also oversee internal investigations and the CAPA program where required.

Requirements

Minimum of Bachelor's degree in related field required.
Minimum of 5 years of experience in clinical research required.
SOCRA or ACRP certification required.
Valid driver’s license and insured automobile required.
All IHI employees are expected to enable multi-factor authentication via their personal smart phone/smart device in order to access IHI systems as a requirement of the role.
Knowledge of research methods and procedures sufficient to review data and prepare reports.
Knowledge of confidentiality requirements related to patient information.
Subject matter expertise (as demonstrated by SOCRA or ACRP certification) and understanding of audit/inspection processes.
Knowledge of GCP auditing.
Knowledge of FDA regulations regarding clinical research, ICH GCP, EMA, MHRA guidelines and applicable international regulations.
Strong technology skills; proficiency in Microsoft Applications, ability to learn and effectively utilize various eCRF systems and an Electronic Medical Record system, and an inclination to adopt technology to maximize efficiency.
Demonstrated analytical and problem solving skills.
Competency in relaying findings in a productive educational manner to ensure staff understanding and ongoing compliance.
High level of attention to detail required.

Nice To Haves

Master's degree in related field preferred.
Good Clinical Practice (GCP) QA leadership experience preferred.

Responsibilities

Conduct internal auditing activities to ensure research studies are performed in compliance with sponsor protocols, Good Clinical Practices (GCPs), SOPs, and applicable regulations.
Document and report on audits. Create/produce audit certificates. As needed, review audit reports with applicable team members.
Create, update, and maintain an annual audit schedule.
Develop and/or review standardized operational procedures (SOP’s) and workflows for research related topics ensuring quality through consistency.
Conduct internal investigations developing Corrective and Preventive Action (CAPA) plans as needed. CAPA trends will be reviewed with Chief Clinical Officer or designees quarterly.
Prepare and assist in follow-up for FDA Inspections. Be available to host the inspection if requested.
Conduct advanced training for physicians and APPs interested in conducting research at IHI.
Serve as mentor and advisor, reviewing study documents including IIS protocols.
Conduct monthly topic specific QA presentations for all staff participating in research studies.
Update research staff on new regulatory changes and new guidance documents.
Participate in training of external, non-IHI personnel such as faculty of Partners Physician Academy.
Member of Research Leadership Team. Participate in new study selection process, interviewing/hiring of new staff, discussing and resolving research related issues or concerns.
Serve as research regulatory advisor for the research department for individual staff members or as a member of a variety of small discussion groups or committees where a research regulatory perspective is necessary.
Supervise a small independent team of Research staff (Research Data Manager, Research Education Coordinator, or other staff as assigned).