Clinical Operations Assistant
We are seeking a Clinical Operations Assistant who will provide general administrative and clinical trial management support to the Clinical Operations department. In this role you will work closely with the Clinical Operations teams in the completion of all required tasks, meeting departmental and clinical study goals.
Come join Omeros!
Come join Clinical Operations!
Who is Omeros?
Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases and disorders of the central nervous system.
The company’s drug product OMIDRIA® (phenylephrine and ketorolac injection) 1% / 0.3% is marketed in the U.S. for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. In the European Union, the European Commission has approved OMIDRIA for use in cataract surgery and other IOL replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.
Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on: complement-associated thrombotic microangiopathies; complement-mediated glomerulonephropathies; Huntington’s disease and cognitive impairment; and addictive and compulsive disorders. In addition, Omeros has a diverse group of preclinical programs and a proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and corresponding compounds, a number of which are in preclinical development. The company also exclusively possesses a novel antibody-generating platform.
What are your job responsibilities?
In this role, your responsibilities encompass supporting the Clinical Operations team with the ongoing conduct of studies and will include:
- Organizing and maintaining clinical study documentation (g.g. SharePoint, TMFs, e-mail correspondence)
- Assisting study teams with study specific documentation and guidelines
- Assisting quality control audits of clinical study documentation
- Assisting with the collection, review and filing of essential documents from the clinical team (Site Monitoring Report, Site Visit Follow-up Letter) and sites (FDA 1572 Forms, training record)
- Coordinating the ordering, handling and tracking of clinical trial materials (patient instructions, lab supplies)
- Assisting in the coordination of site payments
- Attending study team meetings and generating meeting minutes
- Performing administrative tasks to support the study teams with clinical trial execution (copying, scanning, assembling study materials, setting up0 meetings, preparing meeting materials, shipping, etc.)
What education and experience do you need?
You’ll need to have a BS or BA degree in a Life Science or an AA degree (or equivalent) with at least 1 year of relevant experience and a minimum of 5+ years of administrative experience.
What skills and knowledge does our ideal candidate have?
As our ideal candidate, you’ll need the following skills and knowledge:
- Understanding of applicable clinical research regulatory requirements including Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
- Strong computer skills in applications used in general office settings including Microsoft Word, Excel, PowerPoint, and Outlook, and other applications
- Excellent grammatical and proofreading skills
- Strong verbal and communication skills including the ability to write routine reports and correspondence
- Attention to detail and organizational skills
- Strong analytical and problem-solving skills
- Interpersonal skills
- The ability to work in a team environment
- The ability to maintain positive relationships both internally and externally
If you have the skills, knowledge and experience we are looking for, we’d love to hear from you!
Omeros is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status such as race, religion, color, national origin, sex, age, marital status, or any other factor determined to be unlawful by federal, state, or local statutes.
It is our policy to provide reasonable accommodation to anyone with a disability who needs assistance completing the job application process. If you need assistance, you can either send an e-mail to firstname.lastname@example.org or contact Omeros, asking for Human Resources, at (206) 676-5000.