Clinical Research Associate II
Essential Job Functions:
CSA is responsible for all aspects of the clinical study including, but not limited, to the tasks specified below
- Overall Study Support (with minimal oversight)
- Responsible for adherence to all relevant regulations including ICH, PhRMA and CFR guidelines, and Avanir’s policies, SOPs and procedures
- Assist with preparing, collecting, and tracking master study level documents and site documents
- Assist and support reviewing and testing external clinical systems
- Assist Clinical Study Manager to keep CTMS up to date
- Study Concept, Planning and Strategy Phase (with moderate oversight)
- Responsible to support the Clinical Study Manager and/or Director of Clinical Study Management to conduct study feasibility, site selection process, and vendor selection (if applicable)
- Responsible for site budget development and negotiations if needed
- Responsible for initial supplies planning and the development of study specific documents as required
- Study Initiation Phase (with moderate oversight)
- Responsible for document development including informed consent form and study-specific plans
- Responsible for planning and participate in investigator meetings
- Responsible for planning and coordinating study supplies at Investigator sites
- Responsible for collecting essential documents from sites and ensuring sites are trained in collaboration with the site monitor
- Study Management/Conduct Phase (with moderate oversight)
- Responsible for site budget financial management, database lock activities, IMP management, TMF management, study enrollment management (e.g. contingency plan execution), periodic review of protocol deviations, and ensuring AE reporting
- Responsible to support the Clinical Study Manager and/or Director of Clinical Study Management with vendor management and vendor oversight of one or more clinical study vendors
- Responsible to support the Clinical Study Manager with updating of study-level documents and study-specific plans as needed
- Study Close-out Phase (with moderate oversight)
- Responsible for database lock activities
- Responsible for ensuring all documents are filed and reviewed in the TMF
- Responsible for ensuring all site close-out activities are completed
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.
- BA or BS required, preferably in one of the Life Sciences
- 4+ years of experience in the pharmaceutical / biotechnology industry performing as a Clinical Study Associate or equivalent with a combination of experience in clinical site monitoring and in-house study management
- Experience with oversight or mentoring of more junior staff (direct or indirect) preferred
- Good understanding of GCP, ICH Guidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local and country-specific regulations)
- Knowledge of concepts of clinical research and drug development
- Relevant therapeutic experience in pharmaceutical/biotechnology clinical trials
- 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 review and development preferred
- Experience in selection and management of vendors/CROs (Central Lab, IVRS, EDC); previous experience as a Lead CSA preferred
- Experience in global or Phase III clinical trials preferred
- Ability to handle and prioritize multiple tasks simultaneously
- Demonstrates analytical and critical thinking skills
- Possess strong written and verbal communication skills
- Demonstrates strong planning, organizational, and problem-solving skills
- Understand technical, scientific, and medical information
- Understand clinical study budgets
- Work effectively in a team/matrix environment
- Strong computer skills
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.
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.
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.