Baylor College of Medicine · 6 hours ago
Regulatory Affairs Associate - Clinical Research
Houston, TX
Full-time
Hybrid
Entry Level
2+ years expBaylor College of Medicine is seeking a Regulatory Affairs Associate to support the development, submission, and maintenance of regulatory documentation for Investigator-Initiated Protocols, IND studies, and IDE studies. The role involves ensuring compliance with federal regulations and collaborating with various stakeholders to facilitate timely protocol development and regulatory approvals.
EducationHigher EducationPharmaceutical
No H1B
Responsibilities
Assist in drafting, reviewing, and finalizing clinical research protocols for IIPs, IND, and IDE studies in alignment with regulatory standards and institutional guidelines
Prepare and submit regulatory documents to the FDA, IRB, and other governing bodies, including IND/IDE applications, amendments, and annual reports
Ensure adherence to federal regulations (21 CFR), Good Clinical Practice (GCP), and institutional requirements throughout the study lifecycle
Maintain accurate and complete regulatory files, including correspondence, approvals, and essential documents
Work closely with investigators, study teams, and sponsors to provide regulatory guidance and support during protocol development and study initiation
Provide education and assistance to research staff on regulatory processes, protocol requirements, and submission timelines
Contribute to the development and refinement of Standard Operating Procedures (SOPs) and best practices for regulatory compliance and protocol development
Performs other job-related duties as assigned
Qualification
Required
Bachelor's degree
Two years of relevant experience
Minimum of two years' in regulatory affairs or clinical research, with experience in IND/IDE submissions and protocol development
Strong knowledge of FDA regulations, ICH-GCP guidelines, and institutional review processes
Excellent writing and document management skills
Ability to manage multiple projects and meet strict deadlines
Strong verbal, written, and interpersonal communication skills
This position is not eligible for visa sponsorship. Candidates must be legally authorized to work in the United States at the time of application and throughout the duration of employment
Preferred
Master's degree or doctorally prepared applicants are encouraged to apply if they have a strong background in science
Benefits
Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) certification are eligible for certification pay.
The role is eligible for a hybrid work arrangement after completing onboarding and training (typically about 6 months). Hybrid employees are generally required to work at least 2 days in the office.
Company
Baylor College of Medicine
Baylor College of Medicine, located in the Texas Medical Center, is a health sciences university located in Houston, Texas
5001-10000 employees
Funding
Current Stage
Late StageTotal Funding
$10.85MKey Investors
National Human Genome Research InstituteNational Heart, Lung and Blood InstituteCancer Prevention and Research Institute of Texas
2024-12-05Grant· $3.5M
2024-09-26Grant
2024-09-19Grant
Leadership Team
Paul Klotman
President, CEO and Executive Dean
Peggy Smith
Professir and CEO. Teen Health Clinics
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