Regulatory Affairs Associate - Clinical Research job at Baylor College of Medicine in Houston, TX
Title: Regulatory Affairs Associate - Clinical Research
Location: Houston, TX, US
Workplace: Hybrid
Department: Research
Division: Pediatrics
Work Arrangement: Hybrid
Salary Range: $70,618 - $83,000
FLSA Status: Exempt
Work Schedule: Monday – Friday, 8 a.m. – 5 p.m.
Summary
The Regulatory Affairs Associate is responsible for supporting the development, submission, and maintenance of regulatory documentation for Investigator-Initiated Protocols (IIPs), Investigational New Drug (IND) studies, and Investigational New Device (IDE) studies for the Center for Research Advancement in the Department of Pediatrics. This role ensures compliance with federal regulations, institutional policies, and sponsor requirements while facilitating timely protocol development and regulatory approvals. The associate collaborates closely with investigators, clinical research teams, and regulatory agencies to advance innovative research initiatives.
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. Employees working a hybrid schedule may be asked to attend in person meeting and trainings.
Job Duties
Protocol Development
Assist in drafting, reviewing, and finalizing clinical research protocols for IIPs, IND, and IDE studies in alignment with regulatory standards and institutional guidelines.
Regulatory Submissions
Prepare and submit regulatory documents to the FDA, IRB, and other governing bodies, including IND/IDE applications, amendments, and annual reports.
Compliance Monitoring
Ensure adherence to federal regulations (21 CFR), Good Clinical Practice (GCP), and institutional requirements throughout the study lifecycle.
Documentation Management
Maintain accurate and complete regulatory files, including correspondence, approvals, and essential documents.
Stakeholder Collaboration
Work closely with investigators, study teams, and sponsors to provide regulatory guidance and support during protocol development and study initiation.
Training & Guidance
Provide education and assistance to research staff on regulatory processes, protocol requirements, and submission timelines.
Continuous Improvement
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.
Minimum Qualifications
Bachelor's degree.
Two years of relevant experience.
Department Specific Criteria
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.
Preferred Qualifications
Master's degree or doctorally prepared applicants are encouraged to apply if they have a strong background in science.
Work Authorization Requirement:
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.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.
Requisition ID: 24244
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Location: Houston, TX, US
Workplace: Hybrid
Department: Research
Division: Pediatrics
Work Arrangement: Hybrid
Salary Range: $70,618 - $83,000
FLSA Status: Exempt
Work Schedule: Monday – Friday, 8 a.m. – 5 p.m.
Summary
The Regulatory Affairs Associate is responsible for supporting the development, submission, and maintenance of regulatory documentation for Investigator-Initiated Protocols (IIPs), Investigational New Drug (IND) studies, and Investigational New Device (IDE) studies for the Center for Research Advancement in the Department of Pediatrics. This role ensures compliance with federal regulations, institutional policies, and sponsor requirements while facilitating timely protocol development and regulatory approvals. The associate collaborates closely with investigators, clinical research teams, and regulatory agencies to advance innovative research initiatives.
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. Employees working a hybrid schedule may be asked to attend in person meeting and trainings.
Job Duties
Protocol Development
Assist in drafting, reviewing, and finalizing clinical research protocols for IIPs, IND, and IDE studies in alignment with regulatory standards and institutional guidelines.
Regulatory Submissions
Prepare and submit regulatory documents to the FDA, IRB, and other governing bodies, including IND/IDE applications, amendments, and annual reports.
Compliance Monitoring
Ensure adherence to federal regulations (21 CFR), Good Clinical Practice (GCP), and institutional requirements throughout the study lifecycle.
Documentation Management
Maintain accurate and complete regulatory files, including correspondence, approvals, and essential documents.
Stakeholder Collaboration
Work closely with investigators, study teams, and sponsors to provide regulatory guidance and support during protocol development and study initiation.
Training & Guidance
Provide education and assistance to research staff on regulatory processes, protocol requirements, and submission timelines.
Continuous Improvement
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.
Minimum Qualifications
Bachelor's degree.
Two years of relevant experience.
Department Specific Criteria
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.
Preferred Qualifications
Master's degree or doctorally prepared applicants are encouraged to apply if they have a strong background in science.
Work Authorization Requirement:
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.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.
Requisition ID: 24244
Apply Now
Apply Now