Regulatory Specialist Clinical Research
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Campus:
OSU-Center for Health Sciences
Contact Name & Email:
Jeffery Kellerman
Work Schedule:
Monday through Friday 8:00am-5:00pm
Appointment Length:
Regular Continuous/Until Further Notice
Hiring Range:
Commensurate with education and experience
Priority Application Date:
While applications will be accepted until a successful candidate has been hired interested parties are encouraged to submit their materials by to ensure full consideration.
Special Instructions to Applicants:
For full consideration please include a resume cover letter and contact information for three professional references.
About this Position
The Regulatory Specialist is responsible for providing comprehensive regulatory support for clinical research trials. This includes the submission revision and maintenance of protocols in compliance with Food and Drug Administration (FDA) International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) Guidelines and Regulations. The Regulatory Specialist sets up and maintains regulatory files and documentation ensures accurate tracking and processing of protocol-related paperwork for both lead and participating sites and collaborates with internal and external stakeholders to facilitate the conduct of clinical research.
Required Qualifications:
- High School/GED
Compliance legal paralegal healthcare compliance research compliance
(degree must be conferred on or before agreed upon start date)
Prior healthcare legal compliance or research experience.
Skills Proficiencies and/or Knowledge:
- Excellent cognitive organizational and interpersonal skills to support intelligent safe and effective decision-making.
- Strong communication skills both written and verbal.
- Effective customer service skills in person and via telephone.
- Research skills necessary to conduct clinical studies.
- Proficient in Microsoft Office computer skills.
- Strong organization and multi-tasking abilities.
Preferred Qualifications:
- Bachelors
- Certified Paralegal or bachelors degree preferred.
- Two years of clinical research experience preferred.
- Experience in regulatory and compliance within clinical research is preferred.
Certifications Registrations and/or Licenses:
- National Association of Legal Assistants (NALA) certification
- Society of Clinical Research Associates (CCRP)
- Association of Clinical Research Professionals (CCRP)
Required Experience:
IC
Key Skills
- Laboratory Experience
- Spss
- Data Collection
- Genetics
- R
- Research Experience
- Statistical Software
- Cell Culture
- Molecular Biology
- Microscopy
- Research Laboratory Experience
- Western Blot
