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

IKO North America

Territory Sales Representative Job at IKO North America

Role: Territory Sales Representative Job Summary: The Territory Sales Representative (TSR) is responsible for planning and managing territory activities to achieve sales and market share growth utilizing approved sales and marketing strategy and tools while providing...

S&K Building Services

Commercial High-Rise Window Cleaning Technician Job at S&K Building Services

 ...S&K Building Services is expanding our team across the nation and looking for a Commercial High-Rise Window Cleaning Technician! As a Technician, youll be an integral part of our team, supporting our client base via rope descent system. Beyond that, if youre looking... 

LHH

Event Coordinator Job at LHH

Job Title: Meetings and Events Coordinator Location: Washington, DC (On-site) Contract Type: Long-Term Contract Start Date: ASAP Pay Rate: $22$26/hour About the Role We are seeking a highly organized and proactive Meetings and Events Coordinator...

Pair of Thieves

Production Manager Job at Pair of Thieves

 ...Pair of Thieves is seeking a Production Manager to oversee the product lifecycle: complete developed product through vendor execution...  ...retailers) Excellent organizational skills & attention to detail Demonstrated strong communication skills: written and verbal... 

Selby Jennings

Investment Banking Experienced Analyst Job at Selby Jennings

 ...This client is a leading investment bank in NYC looking to expand their Consumer Group with a highly motivated Investment Banking Analyst II/III. This is an opportunity to work in one of the highest revenue-generating groups on the platform. You will gain exposure to...