Clinical Research Associate II

Avanir Pharmaceuticals, Inc Aliso Viejo , CA 92698

Posted 3 weeks ago

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

Education/Qualifications:

  • 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).

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.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Sr Clinical Affairs Research Specialist

Ambry Genetics

Posted 5 days ago

VIEW JOBS 4/17/2019 12:00:00 AM 2019-07-16T00:00 Experienced genetic counselor with research experience or scientist with clinical research experience who works within the clinical affairs department plan and execute external collaborative research and/or data sharing projects. In addition, the Sr. CAR Specialist also works closely with other members of the Clinical Affairs team and interdepartmentally on internal research projects, including creation and maintenance of dossiers and other evidence necessary to support market access in the reimbursement of our products. This individual will oversee the collaborative process throughout the duration of each project. Position Duties and Responsibilities: * Foster relationships with potential collaborators and key opinion leaders across Ambry's menu, including project lead with external collaborators in the plan and execution of research projects * Prioritize efforts based on urgency for sharing data, and feasibility with internal infrastructure * Analyze and write abstracts, presentations, and papers for publications as needed * Works closely with the marketing department to increase visibility of research and depth of clinical data available at Ambry through all venues including conferences, website, and client interactions in the field. * Support and lead the development and execution of assigned dossiers and other project needed to support the Market Access team * Provide clinical and scientific guidance to business development as needed, and clinical evidence and research support to the clinical diagnostics team. * Engage with Clinical Affairs management team in the continual growth of the department, including development of strategies for streamlining work processes and creative solutions for support of commercial and diagnostic teams at Ambry. Position Requirements: * Post-baccalaureate degree in Genetic Counseling, Health Science or other related field, or equivalent combination of education and applicable job experience. * Preferred: Board Certified (or Active Candidate) by the American Board of Genetic Counseling, PhD in field related to clinical genetics or equivalent board certification for other health care providers. * Experienced, comfortable, and effective at public speaking . * Good organizational, time management, and communication skills * Able to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information. * Experience with scientific process, including hypothesis development, data curation, data analysis, basic statistical analyses, scientific writing, and publication. * 6 plus years prior experience in genetics services, product management, clinical affairs and/or clinical research. * Experience in genetic counseling and/or genetics laboratory services preferred. Experience working in a clinical research setting preferred. Location & Schedule: * This position is ideally on-site but can sit remote anywhere throughout the United Sates. * Candidates must be willing to work normal business hours in their local time zone (Monday - Friday 8:00am - 4:30pm) with occasional travel * Location & schedule is subject to change at any time for any reason based on business needs. About Us: Ambry Genetics Corporation is a CAP-accredited and CLIA-licensed molecular genetics laboratory based in Aliso Viejo, California. We are a genetics-based healthcare company that is dedicated to open scientific exchange so we can work together to understand and treat all human disease faster. At Ambry, everyone is welcome. A career at Ambry Genetics is a chance to be part of a dynamic company that aims to improve health by understanding the relationships between genetics and human disease. We earned our reputation as industry leaders by responsibly introducing cutting-edge genetic testing solutions and continually sharing what we learn with the global scientific community. We also support those with genetic conditions through the Mauli Ola Foundation and other nonprofit organizations. At Ambry you will be learning, challenging yourself, and having fun while collaborating with teammates through the open exchange of ideas. Employees at Ambry Genetics have many perks, including an onsite café with complimentary smoothies and infused waters! We also offer access to gym memberships, onsite food trucks, "Lunch and Learns," and more. Our outstanding benefits program includes medical, dental, vision, 401k, FSA, and generous paid time off (PTO) program. Ambry Genetics is an Equal Opportunity Employer (EOE) and we maintain a drug-free work environment. Ambry Genetics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Ambry Genetics Aliso Viejo CA

Clinical Research Associate II

Avanir Pharmaceuticals, Inc