Regulatory Analyst 2
Regulatory Analyst 2
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Job Description
Current Employees:
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The Remote SCCC Regulatory Analyst II reviews prepares and provides oversight for initial and subsequent regulatory submissions from study startup through study closure as well as the maintenance of regulatory documents to ensure compliance with applicable requirements and regulations.
Primary Responsibilities:
Oversees and provides support for the process of study submissions (initial and amendment) and regulatory document maintenance; serves as point of contact for various boards committees and industry academic and cooperative sponsors. Submits or assists in the submission of applications for institutional clinical trials. Sends decision correspondence to appropriate parties requesting information. Assists with the drafting preparation and presentation of programs to investigators and their research staff to raise awareness of research compliance. Maintains current knowledge of applicable regulatory topics (e.g. institutional SOPs federal regulations etc. and adheres to university and departmentlevel policies and procedures and safeguards University assets. Ensures compliance of general and study specific regulatory related processes with institutional SOPs FDA NIH and other applicable regulations.
Requirements:
Education: Bachelors Degree in relevant field
Certification and Licensing: Not required but recommended (e.g. SOCRA CCRP)
Experience: Minimum two 2 years of relevant experience in fields such as compliance research and/or medical/clinical. IND/IDE/FDA experience preferred.
Knowledge Skills and Attitudes:
Ability to maintain effective interpersonal relationships
Ability to communicate effectively in both oral and written form
Ability to utilize sound judgment analyze problems provides solutions and makes decisions.
Skill in collecting organizing and analyzing data.
Highly organized proactive and detail oriented
Excellent skills in timemanagement prioritization and multitasking
Proficiency in computer software (i.e. Microsoft Office Adobe Acrobat)
Ability to establish and maintain effective working relationships with diverse set of internal/external cross functional coworkers managers and clients.
Ability to analyze organize and prioritize work under pressure while meeting deadlines.
Knowledge of processes associated with clinical trials
Knowledge of applicable federal state and local rules and regulations
The University of Miami offers competitive salaries and a comprehensive benefits package including medical dental tuition remission and more.
UHealthUniversity of Miami Health System South Floridas only universitybased health system provides leadingedge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center we are proud to serve South Florida Latin America and the Caribbean. Our physicians represent more than 100 specialties and subspecialties and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching research and patient care. Were the challenge youve been looking for.
The University of Miami is an Equal Opportunity Employer Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.
Job Status:
Full timeEmployee Type:
StaffPay Grade:
H9Required Experience:
IC
Employment Type
Full-Time
