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

Kelly

BSL3/4 Animal Biologist Job at Kelly

 ...preparing and amending animal care protocols, and supporting annual reporting to oversight bodies. Education and Experience ~ Bachelors Degree ~5 or more years of working experience in a lab setting ~ Demonstrates knowledge of maintaining accurate and detailed... 

Aptino, Inc.

Pharmacist Job at Aptino, Inc.

 ...tasks and follow all pharmacy protocols. Promote teamwork and support colleagues as needed. Qualifications: Bachelors or advanced degree in Pharmacy from an accredited institution. Licensed pharmacist in Tennessee (active and unrestricted). Experience... 

The Judge Group

Group Facilitator Job at The Judge Group

Group Facilitator Location: La Plata, Maryland Job Status: Full-Time, Salaried Position Summary The Group Facilitator is responsible for delivering structured substance use disorder and mental health group programming for patients in a residential recovery...

Peyton Resource Group

Installation Foreman Job at Peyton Resource Group

About the Company Our client is a rapidly growing company specializing in commercial signage installation. With continued growth and a strong pipeline of projects, they are looking to add an experienced Installation Foreman to their team. Position Overview The...

Skechers

Technical Solutions Analyst (Workday) Job at Skechers

WHO WE ARE: Headquartered in Southern California, Skechersthe Comfort Technology Companyhas spent over 30 years helping men, women, and kids everywhere look and feel good. Comfort innovation is at the core of everything we do, driving the development of stylish, ...