Temp Regulatory Document Specialist 3 Target Openings 40 Hour Day Timi
Temp Regulatory Document Specialist 3 Target Openings 40 Hour Day Timi
Posted on :
09-04-2025
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1 Vacancy
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Job Description
QUALIFICATIONS:
- Minimum of Bachelors degree in scientific field with interest in Regulatory Affairs Quality Assurance/Control
- 01 years experience in documentation quality control quality assurance and/or regulatory affairs
SKILLS/ABILITIES/COMPETENCIES REQUIRED:
- Knowledge of Good Clinical Practice US Federal Regulations (Title 21 Code of Federal Regulations) applicable Health Canada regulations and general clinical research operations.
- Knowledge of business and management principles involved in strategic planning and coordination of people and resources.
- Ability to use logic and reasoning to identify strengths and weaknesses of alternative solutions or approaches to problems.
- Ability to understand measures or indicators of system performance and actions needed to improve or correct performance relative to the goals of the system.
- Ability to communicate effectively in writing as appropriate for the needs of a beginner audience.
WORKING CONDITIONS:
Busy office environment with frequent deadlines
GENERAL SUMMARY/OVERVIEW STATEMENT:
The Regulatory Document Specialist is responsible to handle the coordination collection review and maintenance of regulatory documentation to ensure compliance of the TIMI Study Group as an academic research organization; specifically as delegated by trial sponsors and under applicable institutional policy
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Assist with the development of systems/procedures to efficiently collect regulatory documents from clinical sites.
- Undertake capacity building of novice clinical research professionals understanding of regulatory affairs by assisting with the development and implementation of training initiatives.
- Understand and apply principles of regulatory affairs and compliance in document review.
- Provide technical review of regulatory documentation to ensure sponsor site file compliance.
- Monitor controls to limit undue bias and recommend strategies for maintenance/improvement.
- Identify gaps in compliance knowledge and practice and support corrective and preventative action plans.
- Prepare study files for audit/inspections by sponsor or agencies by conducting preparatory regulatory document quality checks.
- Advise on Canadian and US regulations that dictate clinical research practices applicable under INDs.
- Work with other TIMI departments as quality support is needed.
- Other duties as appropriate.
Brigham and Womens Hospital is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race sex color religion national origin sexual orientation protected veteran status or on the basis of disability.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
Key Skills
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