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Oklahoma State University · 2 days ago

Regulatory Specialist - Clinical Research

Tulsa, OK

Full-time

Onsite

Entry Level

2+ years exp

Oklahoma State University is seeking a Regulatory Specialist for their Center for Health Sciences. The role involves providing comprehensive regulatory support for clinical research trials, ensuring compliance with FDA, ICH, and GCP guidelines, and maintaining regulatory files and documentation.

EducationSocial ImpactUniversities

Culture & Values

Responsibilities

Providing comprehensive regulatory support for clinical research trials

Submission, revision, and maintenance of protocols in compliance with FDA, ICH, and GCP Guidelines and Regulations

Setting up and maintaining regulatory files and documentation

Ensuring accurate tracking and processing of protocol-related paperwork for both lead and participating sites

Collaborating with internal and external stakeholders to facilitate the conduct of clinical research

Qualification

Regulatory complianceClinical research experienceMicrosoft OfficeResearch skillsNALA certificationCCRP certificationCustomer service skillsMulti-tasking abilitiesCognitive skillsInterpersonal skillsCommunication skillsOrganizational skills

Required

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

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

National Association of Legal Assistants (NALA) certification

Society of Clinical Research Associates (CCRP)

Association of Clinical Research Professionals (CCRP)