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

NX Direct

Junior Account Manager Job at NX Direct

 ...Junior Account Manager - Entry-Level Opening Are you looking for a career that delivers opportunities based on your OWN personal development and competitive spirit, rather than your experience level? The entry-level Junior Sales Account Manager at NX Direct provides... 

Virtus Healthcare Staffing

Registered Nurse (RN) - Renal Telemetry Job at Virtus Healthcare Staffing

#Healthcare #Nursing #RegisteredNurse #Nephrology #Telemetry Registered Nurse (RN) - Renal Telemetry Location: Everett, WA Position Highlights: Specialized Patient Care: Focus on providing dedicated nursing care to patients... 

ELEVATE Marketing & Co

Entry-level Marketing Coordinator Job at ELEVATE Marketing & Co

 ...As an Entry-Level Marketing Coordinator, youll play an essential role in supporting the planning, coordination, and delivery of marketing campaigns. Youll assist with campaign logistics, engage with customers, and work closely with the marketing team to ensure smooth... 

Motion Recruitment

Javascript Developer Job at Motion Recruitment

 ...Are you a React expert with a passion for building cutting-edge, customer-facing applications...  ...you thrive in leading teams, mentoring developers, and working on high-impact digital...  ...&##128640; Were Hiring: Senior React JS Developer | Irving, TX What Youll Do... 

American Spoon

Seasonal Warehouse Assistant Job at American Spoon

About American Spoon In 1982, we began making preserves in our Northern Michigan storefront kitchen. After all these years, our skilled crew still prepares fruit by hand and cooks with care in small-batch copper kettles. We work directly with a dedicated group of Michigan...