SUMMARY: This position conducts quality review on regulatory documents and client deliverables to ensure completion and accuracy for IRB, client or internal review and compliance with applicable regulations and standard operating procedures within established timelines. Additionally, this position enhances and maintains the quality of services provided to clients. This position also supports continuous quality improvement and other quality initiatives.
ESSENTIAL DUTIES AND RESPONSIBILITIES: Other duties may be assigned as needed.
1. Ensures compliance with Federal Regulations, ICH Guidelines, Standard Operating Procedures (SOPs), and company policies.
2. Performs quality review of client submissions and study related documents, for accuracy and compliance with applicable regulations and standard operating procedures.
3. Performs study file audits, in support of client submissions, to determine accuracy and compliance with applicable regulations and standard operating procedures.
4. Communicates effectively with clients to identify and promptly resolve issues related to submitted documents.
5. Communicates effectively with team members to promptly resolve issues related to the quality of documents.
6. Provides procedural guidance related to submission of study documents to clients and team members.
7. Actively contributes to and assists with continuous quality improvement and other quality initiatives.
8. Contributes ideas and suggestions to leadership team for improvement to enhance services or processes, both for internal and client value.
9. May assist with periodic audits of study files.
10. May assist with file verification of regulatory documents.
11. May assist with compilation and reporting of quality-related metrics to management.
12. May attend educational conferences.
QUALIFICATIONS:
To perform in this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
EDUCATION AND/OR EXPERIENCE:
1. At least three years’ experience supporting clinical trials or IRB activities. Will consider other industry or related experience.
2. Working knowledge of and the ability to interpret all IRB-related regulations
3. Previous experience in quality review of regulatory documents
4. BA/BS degree preferred
KNOWLEDGE, SKILLS AND ABILITIES:
1. Excellent organizational and oral/written communication skills including good grammatical and proofreading skills
2. Detail oriented; ability to provide accurate quality review in a fast-paced, deadline driven environment
3. Must be self-motivated with proven ability to prioritize and handle multiple tasks effectively and accurately
4. Ability to establish priorities and respond promptly to a large variety of requests and needs, in a fast-paced and deadline driven environment
5. Successfully works independently and within a team
6. Successfully applies problem solving and critical thinking skills
7. Knowledge and application of MS Office Suite and other web-based programs
COMPETENCY: To perform the job successfully, an individual should demonstrate the following competencies:
Analytical – Synthesizes complex or diverse information; uses intuition and experience to compliment data
Customer/Client Service – Manages difficult or stressful client situations; responds promptly to client needs; solicits client feedback to improve service; responds to requests for service and assistance
Language Ability – Possesses the ability to read, analyze, and interpret general business documents, SOPs, regulatory documents, technical procedures, and IRB-related regulations; writes business correspondence independently; speaks effectively and presents information and ideas clearly; responds concisely and efficiently to questions from clients and team members.
Organization – Prioritizes and plans work activities and uses time efficiently
