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

Green Paws Chicago

Chicagoland In-Home Overnight Pet Sitter Job at Green Paws Chicago

 ...opportunity to thrive in an independent work environment; enjoy the fresh air; get exercise...  ...while youre doing your full-time remote-work job. This position entails staying...  ...additional pay available for evening and weekend work) Office support to manage client relationships... 

ColumbiaCare Services

Residential Care Associate I - 5277 Job at ColumbiaCare Services

 ...pm 11:30pm (Part Time, Swing) What Youll Make $20.60 - $21.86 per hour DOE/Credentials. An additional $3.00 per hour night shift differential will apply during the work hours of 10:00pm - 6:00am. Additional 5% Language Differential offered for Bilingual... 

Mastech Digital

Senior Frontend Developer Job at Mastech Digital

UI Developer Westlake, TX Full Time Required Skills: 1.) Angular 2.) NodeJS (API Integration)3.) AWS **Must be a solid communicator**

Wingstop

Cashier Job at Wingstop

Main responsibilities of a cashier: Managing transactions, making sure pricing is accurate Accepting payments and providing...  ...and has made Wingstop one of the fastest-growing brands in the restaurant industry. Wingstop is the destination when you crave fresh... 

Rails

Part-Time Keyholder - San Francisco Job at Rails

Founded in 2008 by Los Angeles native Jeff Abrams, Rails has grown from a small label - started with just a single hat - into a full collection of womens and mens apparel. Sold at top international retailers and worn by a loyal following of celebrities and tastemakers...