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

Henkels & McCoy, Inc.

Construction Supervisor Job at Henkels & McCoy, Inc.

Henkels & McCoy, Inc. (H&M) is a leading utility construction firm providing critical infrastructure for the power, oil & gas pipeline, telecommunications, and gas distribution markets throughout North America. Founded in 1923, the firm adapts a century of experience to...

University of Maryland Medical System

Registered Nurse (RN), Shock Trauma, Hyperbaric, Part Time Job at University of Maryland Medical System

 ...of nursing. Located in downtown Baltimore near the Inner Harbor and Camden Yards, you wont find a more vibrant place to work! Part Time Position, three 10 hour shifts per week Job Description General Summary ~ This role is considered the minimum role for all... 

Custom Seating

Materials Manager Job at Custom Seating

 ...paced environment with frequent change in dynamics. Communication proficiency, both oral and written Strong analytical and mathematical skills Education and Experience: 10 years of purchasing Purchasing experience in a manufacturing environment ... 

Keller Augusta

Analyst/Associate - Real Estate Investor Relations & Client Reporting Job at Keller Augusta

 ...Position Overview: Our clients US Real Estate team seeks to hire an Analyst/Associate to support existing investors and work on growth initiatives to help expand the platform. This position emphasizes investor reporting, client inquiries, portfolio analysis, asset management... 

Pandora

Analyst, Carrier Job at Pandora

 ...B2B Carrier Analyst, Pandora NAM Do you want to be a part of the worlds leading jewelery company while putting your experience in Internal Communication into use? If yes, then we might have an exciting opportunity for you! You will be part of an exciting business...