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

Remerg

Program Manager Job at Remerg

 ...Job Title: Program Manager Location: Denver, Colorado (On-site) Organization: Remerg Reporting to: Executive Director About Remerg: Founded in 2015, Remerg is an innovative nonprofit dedicated to supporting individuals transitioning from incarceration... 

Prairie Consulting Services

Security Project Manager Job at Prairie Consulting Services

Project Manager Cybersecurity / Technology Risk (Contract) Chicago, IL | Hybrid Were hiring a Cybersecurity-focused Project Manager for a contract role with our direct client in Chicago. What youll do: Lead cybersecurity and technology risk initiatives...

Ameriship Parcel Delivery

Courier/Independent Contractor Job at Ameriship Parcel Delivery

Job Details: Position: Delivery driver Pay: $400 - $1,300 per week (paid per delivery) Job Type:Independent Contractor/Courier Schedule: Monday through Friday (Saturday Availability) Location: Englewood, CO 80110 Job Summary: Ameriship Parcel Delivery...

Paradigm Oral Health

RCM Specialist I Job at Paradigm Oral Health

 ...benefit gather across dental or medical payers, clean pre-...  ...insurance processing, and a positive experience for patients and supported offices...  ..., claim submission, charging/coding requirements, insurance AR...  ...Certified Professional Coder (CPC) or Certified Revenue Cycle... 

Tata Consultancy Services

Logistics Coordinator Job at Tata Consultancy Services

Daily Tasks (not limited to) Prioritize shipments based on critical/premium status. All critical/premium shipments will be executed first, regardless of mode. Air shipments prioritized based on priority: NFO Next flight out (Highest Priority Critical/Premium...