Supports multiple complex clinical research studies
Plans, develops and prepares all required regulatory documents
Supports submissions to ancillary committees
Interfaces with relevant review boards and sponsors to resolve questions or issues regarding regulatory submissions
Collaborates with the Research Business Services Office to assist with initial study submission, amendments and closeout
Acts as a liaison to investigators and research coordinators for reporting Adverse Events, noncompliance, and other FDA required reporting events
Maintains study level documentation for all studies
Ensure files are audit ready
Monitors compliance required documentation
Enters and maintains study information and regulatory approvals in electronic systems
Provides guidance and training to research staff to ensure compliance with highly complex regulations
Attends and participates in educational programs, meetings and assigned committees
Participates in the development and implementation of quality improvement and quality assurance activities

Requirements

Bachelor's Degree (or equivalent knowledge) in Business or related field
Bachelor's Degree (or equivalent knowledge) in Health Care Administration or related field
Typically requires 3 years of experience in research, clinical trials research and regulatory knowledge
Knowledge of FDA and DHHS regulations and ICH GCP guidelines
Knowledge of policies, procedures and SOPs specifically related to regulatory documents
Knowledge of clinical trials and terminology required
Excellent verbal and written communication skills
Organizational and time management skills with ability to work under pressure and meet deadlines
Ability to problem solve and work independently with a high degree of accuracy and attention to detail
Good understanding of computer software such as Microsoft Office, Word, Excel, Adobe, and Teams
Ability to travel between facilities as needed

Benefits

Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

regulatory documentsclinical trials researchFDA regulationsDHHS regulationsICH GCP guidelinespolicies and proceduresSOPsadverse event reportingcompliance documentationquality assurance

Soft Skills

verbal communicationwritten communicationorganizational skillstime managementproblem solvingindependenceattention to detail