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

CNH Industrial

Depot Operations Manager Job at CNH Industrial

 ...Job Description Depot Operations Manager Requisition ID: 2144 Job Location: Lebanon - Indiana - United States Job Family for Posting: Operations Job Type for Job Posting: Full Time About Us Innovation. Sustainability. Productivity. This is how we... 

Arizona Center for Cancer Care

Physician Assistant - Urology Job at Arizona Center for Cancer Care

The physician assistant manages all aspects of the patients care as pertains to comprehensive assessment, diagnosing, and treating medical conditions, with appropriate input from supervising physician, as necessary. It is important that a friendly, caring, courteous, and...

CPS Outdoors

Project Manager Job at CPS Outdoors

 ...Company Description CPS Outdoors specializes in designing and building high-quality custom pools and outdoor spaces that combine style, functionality, and durability. By focusing on delivering exceptional craftsmanship, the company creates unique environments that... 

Wrap-It Storage®

Ecommerce Specialist / Wizard Job at Wrap-It Storage®

Ecommerce Specialist / Wizard St. Paul, MN (On-site) About Wrap-It Storage Were Wrap-It Storage a fast-growing , family-owned company on a mission to help people Get Untangled! And, well, just plain organized. Were a lean (but mighty!) team where ideas...

Emerald Energy and Exploration Land Company

Right-of-Way Agent Job at Emerald Energy and Exploration Land Company

 ...some of the things you'll be doing: Working directly under the direction of the Right...  ...from property owners for various types of surveys Preparing documents necessary for...  ...~75% (Preferred) Work Location: Home based with field work as needed. ADDITIONAL...