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Regulatory Specialist I (2760) at DM CLINICAL RESEARCH GROUP
Karachi Division, Sindh, Pakistan -
Full Time

Start Date

Immediate

Expiry Date

26 Mar, 26

Salary

0.0

Posted On

26 Dec, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Regulatory Documentation, Clinical Research, IRB Applications, Quality Assurance, Communication Skills, Microsoft Office, Time Management, Relationship Management

Industry

Biotechnology Research

Description
Job Details Job Location: Corporate - Karachi (KHI) - Karachi, Sindh 75600 A Regulatory Specialist I works closely with our Clinical Research sites to ensure the integrity and accuracy of all regulatory documentation within the organization. DUTIES & RESPONSIBILITIES Prepares, facilitates, and coordinates the process for accurate and timely submission of Institutional Research Board (IRB) applications for protocol revisions Follows up, communicates, and facilitates responses to queries of the IRB, Sponsor, and other committee as a result of their review of submissions Coordinates the preparation and submission of consent forms in compliance with the regulatory requirements of federal, state, and local agencies governing biomedical research Perform regulatory binder maintenance and quality control checks Participates in quality assurance (QA) and control programs related to the overall project and regulatory compliance Any other tasks as assigned by management KNOWLEDGE & EXPERIENCE Education: Associates degree, required Bachelor's degree, preferred Experience: FDA, IRB administration, research, and regulatory affairs familiarity 12 months of clinical research experience Credentials: N/A Knowledge and Skills: Strong written and oral communication skills. Strong computer skills, including Microsoft Office, Excel, and PowerPoint. Ability to manage time-sensitive projects in order to meet deadlines. Strong ability to establish and maintain effective working relationships. Qualifications
Responsibilities
The Regulatory Specialist I prepares and coordinates the submission of Institutional Research Board applications and ensures compliance with regulatory requirements. They also maintain regulatory binders and participate in quality assurance programs.