Avanir Pharmaceuticals

Clinical Research Associate II

Aliso Viejo, CA, United States
Oct 23, 2020
Biotech Beach
Required Education
Associate Degree
Position Type
Full time
The Clinical Research Associate II will be responsible for initiation, monitoring and other tasks associated with the study management of clinical studies. The Clinical Research Associate II will also be responsible for site management for clinical studies and will assist in the creation and implementation of protocols, informed consents, case report forms, clinical study reports and related study materials.

Essential Job Functions:
  • Ensure the conduct of all clinical studies is in accordance with Good Clinical Practices, International Harmonization Guideline, and appropriate Standard Operating Procedures (SOP)
  • Serve as clinical contact for a study including CROs/vendors, Investigators and study coordinators
  • Actively participate in the implementation and execution of clinical trial activities from study planning through closure
  • Support the Clinical Study Manager and/or Director of Clinical Research with vendor selection and vendor management, including the Contract Research Organization ("CRO") and other clinical study vendors (Central Lab, IVRS, Scale Management, etc.)
  • In conjunction with the Clinical Study Manager and/or Director of Clinical Research, manage site selection process for clinical studies
  • Assist and support development and review of clinical protocols, informed consent forms, or other study-related clinical documents (e.g. Case Report Forms, Source Documents, Monitoring Plan, Data Management Plan, Project Management Plan, etc.)
  • May accompany CRO/CRA's to monitor activities at clinical study sites to assure adherence to Good Clinical Practices (GCP's), SOP's and study protocols
  • May perform site qualification, initiation, monitoring, and/or close out site visits
  • Assist in management and oversight of CRO in terms of the approved study budget and compliance to SOPs, and CRO personnel in terms of performance including selection and termination
  • Order and coordinate study supplies for clinical studies
  • Develop and maintain tracking tools to support management of clinical studies
  • Participate in site budget negotiations
  • Assist in review of vendor contracts and budgets
  • Assist in developing and managing study timelines
  • Plan and participate in Investigator meetings and CRA trainings
  • Assist and support data validation and data clean procedures
  • Assure regulatory compliance of investigational sites with SOP's and FDA and ICH guidelines

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:
  • Minimum of 3+ years of experience in the pharmaceutical / biotechnology industry performing as a Clinical Research Associate with a combination of experience in in-house study management from study start-up to database lock, as well as, clinical site monitoring experience
  • Experience in development of essential clinical study documents, including informed consent, monitoring plans, source documents, Case Report Forms (CRFs), study recruitment plans, etc.
  • Experience in protocol development/writing is preferred
  • Strong, relevant therapeutic experience in pharmaceutical/biotechnology clinical trials
  • Experience in selection and management of vendors/CROs (Central Lab, IVRS, EDC); previous experience as a Lead CRA or Clinical Team Lead is highly preferred
  • Experience in international or global clinical trials is preferred
  • Possess good understanding of ICH guidelines, Good Clinical Practices (GCP), PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, EU directive, and other relevant, local regulatory requirements
  • Experience in leading and working within functional teams
  • Good knowledge of concepts of clinical research and drug development
  • Ability to handle and prioritize multiple studies and projects
  • Ability to work effectively in a team/matrix environment
  • Ability to understand technical, scientific and medical information
  • Demonstrated strengths in planning, organizational, project management, analytical skills, oral and written communication, time management, conflict management, problem solving, attention to detail, and interpersonal skills
  • Strong computer skills

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.