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

EPM Scientific

Manager, Quality Assurance Job at EPM Scientific

 ...Title: Manager, Quality Assurance Location: Springfield, MO (On-site) Summary: The Quality Assurance Manager is responsible for oversight of conditions and activities in API manufacturing areas to ensure continual compliance with cGMP standards. This position... 

Element Care

PCS - Mandarin/Vietnamese/Khmer or Spanish speaking Preferred Job at Element Care

Great Life work Balance position with excellent benefits! The CNA or HHA serves as a member of the PACE Interdisciplinary Team. Under the direction of a licensed nurse, incumbent participates in all aspects of the planning, implementation and evaluation of personal care...

Keeper Security Inc

UX/UI Designer Job at Keeper Security Inc

 ...Keeper Security is hiring a talented, creative and visionary UX/UI Designer to join our passionate team in shaping the next generation of our products and services. This is a 100% remote position. Keepers cybersecurity software is trusted by millions of people and... 

Smith Group of Americas

Administrative Assistant Job at Smith Group of Americas

Position Summary The Administrative Assistant is responsible for maintaining the smooth day-to-day operations of the office, supporting the finance department, to include weekly payroll processing, administrative tasks, and providing HR support as needed under the guidance...

Pandora

Analyst, Carrier Job at Pandora

 ...B2B Carrier Analyst, Pandora NAM Do you want to be a part of the worlds leading jewelery company while putting your experience in Internal Communication into use? If yes, then we might have an exciting opportunity for you! You will be part of an exciting business...