Clinical Trials Associate/Sr. Clinical Trials Associate
In this role you will be responsible for performing in-house clinical trial administrative duties in support of the Clinical Development team’s objectives assisting with the coordination of activities associated with the start-up, conduct and close-out of clinical trials. We require prior experience or training in clinical research and knowledge with GCP/ICH guidelines as well as a thorough knowledge of the clinical trials process and associated regulations, responsibilities and roles.
We are seeking a seasoned Clinical Trials Associate to come join our Clinical Team!
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 will your responsibilities be?
Collaborating with the Clinical Project Team in the clinical development process, you will assist with:
- Development and editing of study-related materials
- Planning, coordination and presentation of information at Investigators’ meetings
- Site management at the direction of other clinical personnel
- Providing support to the clinical sites and clinical team members during the conduct of clinical trials
- Management and tracking of study projects through the use of CTMS or other electronic means
- Management of investigational drug and study supplies by preparing and ensuring the accuracy of shipments of study-related materials (drug orders, study binders, clinical documents, and spreadsheets)
- Facilitating CRF retrieval and query resolution
- The collection, review and filing of regulatory and other documents such as site reports and FDA 1572 forms
What does our ideal candidate look like?
Our ideal candidate is an experienced CTA who is not only familiar with the basic concepts of clinical research but has a thorough knowledge of the clinical trials process and the associated regulations including GCP and FDA regulations, responsibilities and roles required. You’ll have a solid working understanding of GCP requirements, clinical protocols and other essential documents. You possess a high degree of customer focus with both internal and external stakeholders and are able to handle multiple tasks and deadlines.
What education, experience, skills, and knowledge are we seeking?
A 4 year degree from a university is preferred (or equivalent experience) plus a minimum of 2 – 5 or 5 – 8 years of experience, dependent on the level. Having excellent knowledge of the principles and practices of computer applications in database management, you will be experienced in and have a working knowledge of eTMF and CTMS as well as advanced knowledge of Word, Excel and PowerPoint.
If you are an experienced Clinical Trial Associate who wants to work hand and hand with a great Clinical Team, want to be a part of developing internal processes, are looking for a growth, and you have the knowledge and experience we are seeking, this might be the position for 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 email@example.com or contact Omeros, asking for Human Resources, at (206) 676-5000.