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

US Tech Solutions

Family Nurse Practitioner Job at US Tech Solutions

 ...Duration: 6 months contract Job Summary: Nurse Practitioners will work in collaboration with a dedicated clinical care team to provide...  ...practice manager. Job Description: Provide Primary and Family evidenced-based care inclusive of accurate assessment,... 

Dansker Capital Group

Commercial Mortgage Broker Job at Dansker Capital Group

 ...Overview Dansker Capital Group is seeking to add Commercial Mortgage Brokers to our growing team. We are recruiting for full-time onsite openings in our Morristown, NJ office. Incoming brokers will go through a hands-on training and mentorship program with some of the... 

ORBEA

Customer Service Specialist Job at ORBEA

 ...We are looking for a full-time Customer Service Specialist. You are passionate about excellent...  .... You will be working in a dynamic team based in the Orbea USA office, and working...  ..., in Spain. KEY RESPONSIBILITIES Answer dealer, sales representatives and consumer... 

The TJX Companies, Inc.

Finance Manager Job at The TJX Companies, Inc.

 ...Finance Manager, TJX The Opportunity: Contribute To The Growth Of Your Career. At TJX, our Finance organization assists with leading all areas and brands with strategic ad-hoc analysis on some of our most business-critical initiatives, along with leading critical... 

Federal Express Corporation

Package Handler - Part Time (Warehouse like) Job at Federal Express Corporation

IMMEDIATE OPENINGS! Come for a job and stay for a career! Federal Express Corporation (FEC) is part of the rapidly growing warehouse and transportation sector that helps keep America, and our economy, moving. Be part of a winning team and workplace community that cares...