When You Need to Advance Your Career, It Takes Avania

Avania is a leading, global full-service contract research organization focused on the management of clinical studies for medical devices. Avania comprises highly specialized regional team members working together on a global scale to improve the future of human health. We work across a wide variety of clinical trials, and specialize in medical devices, innovative technology, and combination products in numerous therapeutic areas.

Avania is hiring Clinical Research Associates (CRAs) - Western US or Canada

The purpose of Avania’s Clinical Research Associate (CRA) is the establishment, maintenance and support of clinical trials, including but not limited to setting up clinical trials, training study sites on clinical trial procedures, performing monitoring visits, general study coordination and study/site closure. The CRA’s primary responsibility is to perform clinical trial oversight in addition to any study management tasks assigned by the Project Manager.

Through the monitoring process, the CRA verifies that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documents. Further, the CRA makes sure that the conduct of the trial follows approved protocols/amendment(s), with ISO14155 or ICH-GCP, and with applicable regulatory requirements.

Within the CRA function, different levels can be distinguished (level I, II and Sr. CRA). Depending on the level of experience, CRAs can be responsible for tasks that are more complex. At management discretion, a CRA may serve as a Lead CRA for a project if she/he has the appropriate qualifications and training to perform the role. CRAs may initiate certain study start-up tasks until a Project Manager is appointed. Once a Project Manager is appointed, the CRA will work under their guidance to achieve study aims.

Our CRA role includes -

• May act as a Clinical Lead, overseeing clinical trial activities at investigational sites (will require travel to investigational sites).
• Develop and maintain trackers, such as visit reports trackers, site trackers, recruitment and enrollment trackers.
• Member of a site Start-up Team for various projects.
• Conduct and write accurate visit reports in accordance with SOPs and GCP, including pre-study, site initiation, routine monitoring, and close-out visits
• Interact with and guide study investigators and study coordinators in conducting clinical trials in accordance with study protocols.
• Ensure data entered on the CRFs by investigational sites is performed in a timely manner and verify that data is consistent with patient clinical notes, known as source data/document verification (SDV).
• Collaborate with analytical services as appropriate, to obtain clean database, resolve queries and conduct or participate in data reviews (both internally and with sponsor), identifying and communicating trends or erroneous data.
• Monitor site’s completion of action items between visits.

Study-Specific Documents and Files:

• Prepare for audits and inspections.
• Participate in internal TMF reviews, as needed.
• Review and write informed consent forms.
• Review of protocols, investigator brochures on compliance with applicable regulations and CRFs in development.
• Prepare clinical trial agreements and discuss/negotiate between site and Sponsor.

Regulatory Affairs:

• Prepare submissions to Institutional Review Board (IRB) / Ethics Committees (ECs) and Competent Authorities (CAs)/Food and Drug Administration (FDA), assist in administrative tasks for submissions AND follow up until approval is obtained.
• Prepare confidentiality agreements and complete templates of clinical trial/investigator agreements.
• Prepare annual trial progress reports for IRBs/ECs and CAs/FDA.
• Report Serious Adverse Events to Sponsor, IRBs/ECs, CAs/FDA and investigators.
• Communication and Meetings:
• Participate in project meetings and investigator meetings and write minutes.

What we seek -

CRAs require skills in planning and preparation; sourcing and collecting information; prioritizing tasks and actions; and displaying a proactive attitude to assist in project planning and study execution. With our continued growth we are hiring talent to join us on our journey and grow with us!

• B.A./B.S. or equivalent experience in a (para)medical, scientific or health related discipline or related work experience.
• Minimum 3-7 years of relevant work experience in clinical research, in particular as clinical research associate (CRA) preferred.
• Tracker and Start-up experience.
• Ability to understand basic and complex medical details
• GCP-ICH-E6, FDA regulations and ISO 14155, 13485 and 9001 knowledge where applicable
• Knowledge of regulatory regulations and guidelines on medical devices
• Ability to travel domestically and internationally
• Experience as a Clinical Lead helpful
• Ideal candidate will reside in either PT or MT time zone
• Fluent English, spoken and written

What we offer -

• Career path opportunities for your growth within the company
• A dynamic team and the opportunity to work in cross-functional international teams
• Well-outlined training program
• Full, Comprehensive Benefits
• Various team activities

We look forward to receiving your CV!

Avania takes pride in being an equal opportunity employer. We consider qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.

Full, Comprehensive Benefits