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Clinical Research Regulatory Affairs Associate

Job Attributes

Job Id:

30048

Job Category:

Clinical & Life Sciences

Job Location:

Bethesda, MD  20817

Security Clearance:

No Clearance

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions

JOB DESCRIPTION

Piper Clinical Solutions is looking for a driven Clinical Research Regulatory Affairs Associate to join a well-established Clinical Research Organization’s regulatory team in Bethesda, Maryland. The Clinical Research Regulatory Affairs Associate will be involved in supporting clinical trials by providing data management and administrative support to the regulatory department.


Responsibilities for the Clinical Research Regulatory Affairs Associate:

·       Provide administrative support to the regulatory department

·       Prepare standard documentation supporting regulatory filings

·       Maintain files for regulatory documents using trial master files and update electronic databases for clinical trials

·       Develop and maintain Standard Operating Procedures (SOPs) and work instructions

·       Provide administrative support to the regulatory department as needed

·       Experience publishing regulatory submissions using electronic submission standards

·       Track, maintain and update databases with clear and concise information regarding activity of the clinical trial


Requirements for the Clinical Research Regulatory Affairs Associate:

·       1-3 years’ experience within the clinical research industry

·       Experience using electronic submission in preparing documents that are compliant with electronic submission standards is preferred

·       Experience working with Good Clinical Practices and working in FDA regulated environment

·       Knowledge of drug and vaccine development process

·       B.A./B.S. degree required


Compensation for the Clinical Research Regulatory Affairs Associate:

·       Salary up to $50,000 based on experience

·       Benefits: Health, Dental, & Vision insurance and 401K


Keywords:


Regulatory affairs, regulatory associate, regulatory operations, regulatory, clinical research, clinical, research, Good Clinical Practices, GCP, FDA, drug, vaccine, development process, electronic submission, preparing documents, compliant, electronic submission, institutional review board, IRB, investigational new drug, IND, protocols, reporting, data abstraction, ICF, informed consent forms, documentation, electronic filing systems, SOPs, standard operating procedures, administrative support, regulatory documents, benefits, health, dental, vision, 401k, retirement, salary, Bethesda, Rockville



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New Search

Job Id:

30048

Job Category:

Clinical & Life Sciences

Job Location:

Bethesda, MD  20817

Security Clearance:

No Clearance

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions