The Clinical Research Associate will be responsible for the monitoring and other tasks associated with clinical studies. The Clinical Research Associate will also be responsible for investigational site management for clinical studies and will assist in the implementation of protocols, informed consents, case report forms, clinical study reports and related study materials.
Essential Job Functions:
Monitor activities at clinical study sites to assure adherence to Good Clinical Practices (GCP s), SOP s and study protocols
Actively participate in clinical trial activities from study planning through closure
In conjunction with the Project Manager work with the CRO and assist in site selection process
Order and coordinate study supplies at Investigator sites
Assist in maintaining tracking tools
Assist in site budget negotiations if needed
Assist and support data validation and data clean procedures
Assure regulatory compliance of investigational sites with SOP s and FDA and ICH guidelines
Assist the Project Manager (if needed) with vendor management, including the Clinical Research Organization ( CRO ) in monitoring and data management, Drug distribution, Safety and other study vendors.
Assist in planning and participate in investigator meetings
Essential Trial Monitor activities for the largest study of its kind
Develop Strategy and actively participate in creative investigator and patient recruitment programs
Assist in guiding the progress of a landmark safety, effectiveness and outcomes trial
BA or BS required, preferably in one of the Life Sciences
5+ years of experience in the pharmaceutical / biotechnology industry performing as a Clinical Research Associate with a combination of experience in monitoring of sites and in-house study management.
Experience in protocol writing and informed consent development preferred.
Experience in study site selection, site budget development / negotiations and overall site management preferred.
Experience in vendor management (CRO, central laboratory, IVRS, EDC).
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.
Avanir Pharmaceuticals, Inc