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

Tata Consultancy Services

Call Center Representative Job at Tata Consultancy Services

 ...service inquiries. Responsibilities include: Handle inbound calls and email service inquiries on queries such as: o Process &...  ...to provide a first call resolution and positive customer experience. o Consistently meet and exceed goals relating to quality, productivity... 

Manpower San Diego

Bilingual Customer Service Representative Job at Manpower San Diego

 ...Position: Bilingual Onsite Call Center Representative / Office Assistant Location: San Diego, CA 92101, Onsite Duration: Temporary...  ...and business need) Pay: $19$21/hour depending on experience Job Summary: Temporary Office Specialist is needed... 

Russell Tobin

Call Center Representative Job at Russell Tobin

 ...remotely with 45 weeks of training, then transition to full in-office work for hands-on experience and team collaboration. After 6 months,...  ...insurance, an employee assistance program, legal support, auto, home insurance, pet insurance and employee discounts with preferred... 

CVS Health

Lead Director - Enterprise Strategy (Payor, Medicare) Job at CVS Health

 ...framing presentations, both in written deliverables and in facilitating live discussions+ 3+ years of experience in healthcare payor, Medicare, Medicaid or provider consulting experience+ 3+ years' experience presenting to Executives, demonstrating ability to actively... 

Pacioretty Academics

Part-time Advanced Math Tutor Job at Pacioretty Academics

Job Title: Part-Time Advanced Math Tutor Location: Dallas, TX Grade Levels: High School ( Algebra I, Geometry, Algebra II, Pre-Calculus, Calculus, Statistics ) About Pacioretty Academics Located conveniently in Preston Center in Dallas, Pacioretty Academics, named...