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

Lensa

Senior ux researcher - digital Job at Lensa

 ...Any information collected there is subject to their terms and privacy notice. About The Role We are looking for a Senior UX Researcher to lead research strategy for AI-driven monetization and digital advertising experiences. In this role, you will shape how businesses... 

Sol-ti

E-Commerce & Performance Marketing Manager Job at Sol-ti

 ...County or LA preferred Industry Type: Manufacturer Category: Marketing Beverages: SuperFood Beverages, Wellness Shots Employment...  ...marketer with deep experience in CPG, beverage, wellness, or food industries. Career Responsibilities Develop and execute... 

Floor Authority

Outside Sales Representative Job at Floor Authority

 ...will be considered unsolicited and free of charge to Floor Authority. Job Overview: Floor Authority is currently looking for a Sales Account Manager in Charleston, SC. The ideal candidate is responsible for driving sales growth by developing and maintaining strong... 

TN HomeBuyers

Maintenance Technician Job at TN HomeBuyers

Company Overview For over 20 years, TN HomeBuyers has been Nashvilles trusted real estate investment company, helping homeowners sell their houses the easy way with no stress, no delays, and no surprises. Whether someone needs to sell quickly or simply wants a hassle...

NITELINES USA, INC

Medical Coders-Remote Job at NITELINES USA, INC

 ...4 government institutions and medical treatment facilities across the...  ...TX. Location: Temple, TX (Remote). Hours: Monday through Friday...  .... ~11 paid holidays. Coders needed: Inpatient Coders...  ...Technician (RHIT), Certified Coding Specialist (CCS or CCS-P), or...