Regulatory Affairs Associate Job at Baylor College of Medicine, United States

OWpZK0JsbW1BcCsxZjRnaGhnU1RpeWs3N2c9PQ==
  • Baylor College of Medicine
  • United States

Job Description

Summary

Baylor College of Medicine Department of Otolaryngology's Research Division is looking for a Regulatory Affairs Associate who will be responsible for coordinating the regulatory and administrative requirements for conducting research. The ideal candidate will also provide guidance in the accumulation of regulatory documentation.

 

Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) are eligible for certification pay.

Job Duties

  • Manages clinical study regulatory work for a research study or clinical trial.
  • May assist with regulatory affairs training.
  • May assist with IND/IDE submission and reporting to the FDA and other government agencies.
  • Communicates with IRBs and PIs related to submissions, renewals, and adverse events.
  • Creates regulatory reports as needed/requested.
  • Serves as main contact for investigators, sponsors, government agencies, and the IRB. 
  • Explains facts, policies and practices related to job area to internal stakeholders and counterparts.
  • Communicates with contacts both within and outside of job area on matters that require some explanation or interpretation.
  • Influences parties within job area regarding concepts, practices and approaches.
  • May provide guidance, help with training and review work of entry level employees.
  • May lead parts of less complex projects or processes.
  • Performs other job-related duties as assigned.

Minimum Qualifications

  • Bachelor's degree.
  • Two years of relevant experience.

Preferred Qualifications

  • Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with limited experience.

 

 

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

 

 

 

Job Tags

Similar Jobs

Medix™

Certified Medical Coder - 248716 Job at Medix™

 ...Hiring a REMOTE Certified Medical Coder that lives in Arizona! Schedule: M-F 8-5 PM MST Pay Range: Between $25-$29/hr depending on experience & qualfiications Day to day: Expertly assign and sequence diagnostic/procedural codes (ICD-10, CPT, etc.) per... 

Window Cowboy LLC

Window Cleaning Technician Job at Window Cowboy LLC

 ...Window Cleaning Technician Window Cowboy Location: Mooresville, NC & Surrounding Areas Job Type: Full-Time Window Cowboy is looking for a reliable, detail-oriented Window Cleaning Technician to join our growing team. We are a residential-heavy business... 

PrimeSource Building Products

National Account Manager - Home Depot Pro Job at PrimeSource Building Products

 ...National Account Manager Home Depot Pro Compensation: $115,000$130,000 Annual Incentive Plan (AIP): 10% Home Depot Pro National Account Manager Why Join PrimeSource? At PrimeSource Building Products, youll join one of the nations largest and most... 

Guthrie

Trainer, Revenue Integrity Job at Guthrie

Summary: The Trainer, Revenue Integrity is responsible for developing and delivering training programs that support accurate and compliant revenue cycle processes. This role ensures that staff across departments understand and adhere to revenue integrity standards, including...

Judy Blue

Ecommerce Specialist Job at Judy Blue

 ...sitting, typing, attending meetings, and occasional lifting of items up to 10 pounds. Were committed to providing reasonable accommodations to support individuals with disabilities in performing essential job functions. Diversity, Equity, Inclusion & Equal Employment...