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

Nickey Kehoe

Production Associate Job at Nickey Kehoe

 ...needed. Open and willing to learn new skills and take feedback with grace and humility. Minimum 2-3 years of experience in Textiles & Furniture. As an Equal Opportunity Employer, it is our highest priority that no employee or applicant is discriminated against... 

Sciens Building Solutions

Fire Sprinkler Inspector Job at Sciens Building Solutions

 ...THE POSITION IN A NUTSHELL - $5,000 Sign on Bonus Sciens Building Solutions is seeking a Fire Sprinkler Inspector to provide inspection and maintenance capabilities. This position will work closely with our sales team, field project teams, and clients to ensure our... 

Ascend Healthcare Inc

Information Technology Support Specialist Job at Ascend Healthcare Inc

 ...support, and long-term stability. Our work environment fosters: Collaboration and...  ...teamwork Patient-First Mindset Work from home opportunities Career Growth and...  ...verbal and written communication skills for virtual meetings and correspondence. Hearing :... 

Compunnel Inc.

Test Driver Job at Compunnel Inc.

This role involves operating a dedicated mapping vehicle to support mapping and data-collection program across the Greater Phoenix area. Operators complete structured routes, follow detailed instructions, support testing activities, and ensure high-quality data collection...

Dewey

Data Product Analyst Job at Dewey

 ...About the Role We are seeking a highly analytical Data Product Analyst to help evaluate, improve, and evolve data products. This role sits...  ...early and have a meaningful impact on our product. You will work closely with a small team, take ownership of key areas, and help...