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

Keeper Security Inc

UX/UI Designer Job at Keeper Security Inc

 ...Keeper Security is hiring a talented, creative and visionary UX/UI Designer to join our passionate team in shaping the next generation of our products and services. This is a 100% remote position. Keepers cybersecurity software is trusted by millions of people and... 

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...

Vaco by Highspring

Senior Accountant x 90K - 110K + bonus x LA Job at Vaco by Highspring

Senior Accountant - Sr. Accountant - CPA - C.P.A. - Inventory - GAAP - Month End - GL - G/L - General Ledger - Journal Entries - Reconciliation - Financial Reporting - Consolidations Are you a Senior Accountant with 4+ years of experience looking to get in with a high... 

HRH Search & Recruitment

Program Manager, Membership Job at HRH Search & Recruitment

 ...Position Summary The Program Manager, Membership is responsible for developing, optimizing, and expanding membership programs that drive engagement, retention, and long-term value for both corporate and individual members. This role serves as a strategic partner to internal... 

WV Department of Health

Procurement Specialist, Rural Health Transformation Program (RHTP) Job at WV Department of Health

 ...comprehensive statewide initiative focused on revolutionizing healthcare access and quality in rural communities through federally...  ...Bachelors degree in Business Administration, Procurement, Supply Chain Management, Public Administration, or a related field. Minimum...