Avanir Pharmaceuticals

Clinical Operations Associate l

Aliso Viejo, CA, United States
Nov 07, 2020
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
The Clinical Operations Associate will be responsible for execution of assigned clinical operations activities in support of study conduct throughout the study lifecycle and will ensure quality execution and compliance with all required policies and procedures in completion of assigned tasks. This individual will work closely with clinical operations management to ensure adherence to applicable metrics associated with assigned tasks completion.

Essential Job Functions:
  • Responsible for clinical operations aspects of Avanir clinical trials conduct as assigned including but not limited to:
    • (e)Trial Master File and essential documents management
    • Contracts processing and execution
    • Facilitation of Investigator and study registration updates
    • Facilitate development and QC of Informed Consent and other study specific documents
    • Development of processes and controlled documents
    • Facilitate Clinical Document Change Request activities
    • Manage HCP/HCO clinical engagement activities per Avanir policies and procedures
  • Responsible for facilitating clinical Risk Assessment and Quality Management System (QMS) activities (e.g. deviations and CAPAs) including management of activities within the QMS platform
  • Manage and/or support clinical audit activities as assigned
  • Participate in the development, review, implementation and updating of key standard processes that lead to positive and measurable impact for clinical programs managed by the clinical research team (e.g. quality, efficiency, consistency)
  • Lead management of clinical systems updates, enhancements and master data stewardship as required
  • Manage coordination of activities across clinical teams for the completion and continued execution of process improvement and compliance related initiatives as assigned
  • Responsible for tracking and reporting of Key Performance Indicators (KPIs) and metrics for quality oversight of applicable clinical operations related activities as assigned
  • Collaborate/Interact with internal and external stakeholders as related to conduct of required job responsibilities
  • Additional activities may be assigned as appropriate

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.

Education/ Qualifications:
  • Bachelors or equivalent in a scientific or health care field preferred
  • Two (2) years of related experience preferred
  • Experience with PC-Windows, word processing, and electronic spreadsheets required
  • Knowledge of ICH/GCP, local regulatory authority drug research and development regulations and clinical trial operations required
  • Clinical trials support or pharmaceutical industry experience required
  • Demonstrated strengths in planning, organizational, analytical skills, oral and written communication, time management, conflict management, problem solving, and attention to detail
  • Excellent written and verbal communication skills and strong interpersonal skills necessary to interface with team members, outside vendors, and consultants
  • Comfortable in a fast-paced environment and able to adjust workload based on changing priorities
  • Ability to work effectively within a team matrix as well as independently
  • Ability to collaborate and respond to changing circumstances and needs
  • Ability to travel as required to carry out responsibilities
  • Proficient in Microsoft products (Outlook, Word, Excel, PowerPoint)

Physical Requirements:

This position primarily works in an office environment. It requires the ability to sit or stand for long periods of time and frequent walking. Daily use of a computer, phone, office equipment and other computing and digital devices is required. May be required to stand for extended periods when facilitating meetings or walking in the facilities. Some local travel may be necessary, so the ability to travel by plane, operate a motor vehicle and maintain a valid Driver's license and/or effectively navigate public transportation is required. While performing the responsibilities of the job, the employee must be able to read and respond to interoffice communications as well as effectively participate in meetings. The employee is often required to sit and use their hands and fingers, to lift up to 20 lbs., pull, push, carry, handle or feel. The employee is required to carry, handle items, reach with arms and hands, to stoop, kneel, or crouch; talk or hear. Mental demands may require prolonged concentration, reading comprehension, understanding and interpretation of concepts, ideas and philosophies. The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described unless such accommodations would cause Avanir an undue burden.

Work Environment:

While performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job unless such accommodations would cause Avanir an undue burden. While performing the duties of this job, the employee is occasionally exposed to moving carts, mechanical equipment (copiers, computers, coffee machines) and vehicles. May be subject to smells and odors. The noise level in the work environment is usually quiet to moderate. The passage of employees through the work area is average and normal.

EEO Statement:

As an equal opportunity employer, Avanir Pharmaceuticals is committed to providing all applicants and employees with equal access to employment opportunities, regardless of sex, race, age, color, national origin, ancestry, disability, pregnancy, religion, genetic information, sexual orientation transgender status, gender identity, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law. All Avanir Pharmaceuticals employees, officers, principles, agents, and representatives are expressly prohibited from engaging in unlawful discrimination. Consistent with federal, state, and local requirements, Avanir Pharmaceuticals will reasonably accommodate any qualified individual with a disability if such accommodation would allow the individual to perform the essential functions or the job, unless doing so would create an undue hardship.

Avanir Pharmaceuticals shall abide by the requirements of 41 CFR-60-300.5(a) and 60-741.5(a). These regulations prohibit discrimination against qualified individuals on the basis of protected veteran status or disability, and require affirmative action by covered prime contractors and subcontractors to employ and advance in employment qualified protected veterans and individuals with disabilities.