Usona Institute, a non-profit medical research organization founded in 2014, conducts and supports biochemical and clinical research to further the understanding of the therapeutic effects of psilocybin and other consciousness-expanding medicines. Our focus is on alleviating depression and anxiety in people for whom current medical treatments fall short in offering relief and a better quality of life. Additional information about Usona can be found at www.usonainstitute.org.
JOB OBJECTIVE: The Clinical Trial Associate (CTA) will support the clinical research development team with day-to-day cross-functional clinical trial activities, including coordination and documentation of trial related activities, in accordance with Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) and Usona’s Standard Operating Procedures (SOPs). This individual will work closely with various areas to ensure key projects are supported and implemented according to the individual project plans.
1. Administratively assist the Clinical Trials Manager, as needed, in clinical operations activities from protocol concept through study close out in accordance with SOPs, regulations, ICH/GCP and study specific protocols, manuals and procedures.
2. Under the supervision of the Director of Operations, and in collaboration with the Program Development Lead, manage the electronic regulatory submission system, including formatting, uploading, proof reading and publishing of all documents to be submitted to regulators. Ensure relevant team members are aware of upcoming submission deadlines and plan activities accordingly.
3. Assist the clinical research development team members with scheduling internal and external meetings and, where necessary, writing, filing, and distributing meeting minutes, action items, and associated documents.
4. Participate in Usona’s quality assurance activities, in accordance with relevant regulatory requirements, using Usona’s electronic quality management system.
5. Manage the administrative review, approval, and publishing of all internal Usona controlled documents, including Usona’s policies, procedures, and SOPs.
6. In collaboration with the Clinical Trials Manager, assist with developing, maintaining, and managing study related documents, including formatting clinical trial specific documents and conducting literature searches and compiling citations (such as in EndNote).
7. Oversee activities related to Usona’s electronic Trial Master File (eTMF) and, in collaboration with the CRO, conduct periodic reviews and archiving of the eTMF in accordance with the eTMF Management Plan.
8. Support the Program Development Lead in maintaining the project filing/tracking system and report study metrics to the Usona teams.
9. Assist in coordinating Investigator Meeting planning, including preparing meeting materials and on-site meeting logistics.
10. Along with the Clinical Trials Manager, participate in regularly scheduled CRO and other third party vendor meetings.
11. Provide logistical support to the clinical research development team, and assist other staff as requested and perform other related work, as needed,
1. Bachelor’s degree with combination of education/experience in science or health-related field required.
2. At least 2 years of clinical trial experience, preferably in sponsored research. Industry experience a plus.
3. Working knowledge of GCP/ICH guidelines and the clinical development process.
4. Ability to work independently with minimal supervision and prioritize work to ensure the completion of essential deadlines.
5. Strong planning, communication, and organizational skills.
6. Proficiency in the use of Microsoft Office.
7. Some travel may be required.
1. Ability to use telephone and computer equipment.
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