Position: Clinical Research Associate (In House-South and Midwest)
Regions: US South Regions including South Atlantic, East South Central, and West South Central; Selected Regions in US Midwest
Athira is a Bothell, Washington based company. Our mission is to restore lives by advancing bold therapies, thoughtfully and urgently. We are working to provide better care for people through innovative research and accessible products. Using our platform of disease-modifying regenerative small molecules, our current focus is on neurological diseases. An estimated one billion people around the world suffer from neurological disorders including Alzheimer’s Disease, Parkinson’s Disease, Multiple Sclerosis, and more. With both a discovery arm and a research and development arm, we are positioned to lead the development of disease-modifying, life changing therapies addressing one of the largest and most critical unmet medical needs today.
The Clinical Research Associate(CRA) is responsible for the planning and execution of clinical trials. You will assist the Athira Project Lead in managing defined aspects of clinical trials to ensure successful clinical trial conduct, achieving high quality data and timely completion of the planned studies. This will involve visiting the sites, communicating the study conduct status and compliance.
•Assist the Project Lead in managing defined aspects of clinical trials to ensure trials are initiated efficiently and completed on time, within budget, and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines.
•Oversee CRO monitoring activities, including site qualification, study initiation, interim monitoring, and close out visits and completion of associated reports and follow-up letters.
•Develop and/or assist in the development of trial materials (e.g., protocol, informed consent forms, case report forms (CRF), CRF completion guidelines, monitoring guidelines, Site Initiation Visit materials, site tools and worksheets, investigational product administration guidelines).
•Work closely with and provide training to CRO staff, study site staff, and field-based (CRO's) CRAs.
•Create, monitor, and present key study performance metrics with cross-functional Athira study teams.
•Work with the Medical Monitor, Data Management, and Project Lead to review data listings for accuracy, oversee data discrepancy management, and propose remedial measures.
•Work with the CRO to manage start-up activities at trial sites, including IRB/IEC submissions and ensuring the collection and review of required essential documents.
•Escalate any issues in a timely manner to the CRO Clinical Trial Manager.
•Escalate data quality issues in a timely manner to the Project Lead
•Develop strong and effective working relationships within Athira’s Clinical Development team and other functional departments and CROs.
•Ability to travel for periodic site monitoring and/or co-monitoring activities, attend investigator meetings or vendor visits/audits, as required.
•Perform additional remote monitoring as needed.
•BA/BS or equivalent or any relevant and qualifying training with a minimum of 3 years of relevant clinical trial management experience, preferable in a pharma/biotech setting.
•SOCRA or ARCP certification preferred.
•Strong working knowledge of FDA & ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring procedures.
•Exceptional attention to detail.
•Knowledge in CNS indications preferred.
•Rater experience in clinical outcome assessments preferred.
•Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team.
•Highly responsive and proactive, a team player
•Excellent communication and organizational skills and the ability to work effectively in a high paced, fast changing environment.
•Flexible attitude with respect to work assignments and new learning
•Conscientious, influential person with an outstanding work ethic and strong personal discipline
•Proficiency with MS Office products Word, Excel, PowerPoint, Share point
•Comfortable with up to 75% traveling time
•Current authorization to work in the US
Athira is an equal opportunity employer and does not unlawfully discriminate against employees or applicants for employment on the basis of an individual’s race, color, religion, creed, sex, national origin, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline and termination.
Why Work Here?Athira Pharma is a drug development company striving to improve human health by advancing new therapies for neurodegenerative diseases like Alzheimer’s and Parkinson’s. Our innovative approach is focused on turning brain degeneration into regeneration, achieved by re-establishing lost connections and restoring lost function.
Advancing New Therapies for Neurodegenerative Diseases