Senior Clinical Trials Associate - Seattle, WA | Biospace
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Senior Clinical Trials Associate

Omeros Corporation

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Location:
Seattle, WA
Posted Date:
8/30/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

As a member of the Clinical Development Team, you’ll be responsible for performing in-house clinical trial administrative duties in support of the Clinical Development departmental objectives. Utilizing your prior experience in clinical research and GCP/ICH guidelines, you will assist with the coordination of activities associated with the start-up, conduct, and close-out of clinical trials.

Good things are happening at Omeros!
Come join our Clinical Development Group!

Who is Omeros?
Omeros is a Seattle-based biopharmaceutical company committed to discovering, developing, and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies, and disorders of the central nervous system.
Derived from its proprietary PharmacoSurgery® platform, the company’s first drug product, Omidria® (phenylephrine and ketorolac injection) 1%/0.3%, has been approved by the FDA 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 (EC) has approved Omidria® for use in cataract surgery and lens replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.
Omeros has five clinical-stage development programs focused on: complement-related thrombotic microangiopathies; Huntington’s disease, schizophrenia, and cognitive impairment; addictive and compulsive disorders; and preventing problems associated with urologic surgical procedures. In addition, Omeros has a proprietary GPCR platform, which is making available an unprecedented number of new GPCR drug targets and corresponding compounds to the pharmaceutical industry for drug development.

What are your job responsibilities?
Collaborating with the Clinical Project Team in the clinical development process you will be responsible for the coordination, logistics, tracking and administrative tasks in support of clinical trials assisting with the following:
•   Development and editing of study-related materials
•   Planning, coordination and presentation of information at Investigators’ meetings
•   Site management
•   Providing support to the clinical sites and clinical team during the conduct of the clinical trials
•   Management and tracking of study projects through CTMS or other electronic means
•   Management of investigational drug and study supplies by preparing and ensuring the accuracy of shipments of study-related materials
•   Flow of data including facilitating CRF retrieval and query resolution
•   The collection, review and filing of regulatory and other documents such as site reports and FDA 1572 forms
•   Data query resolution process

Requirements

What experience and education do you need?
You’ll need a Bachelor’s degree or equivalent and a minimum of 5 years of clinical research experience in a pharmaceutical/biotech or CRO setting is desired.
Additional experience we are seeking includes the following:
•   Experience in interactions with outside CROs and other vendors
•   Knowledge and understanding of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines
•   Experience providing clinical operations expertise to clinical development in a specified project or project area
•   Working knowledge and experience with electronic data capture (EDC) systems and CTMS


What skills and knowledge does our ideal candidate have?
As our ideal candidate, you’ll need the following skills and knowledge:
•   Thorough knowledge of the clinical trials process and familiarity with the advanced concepts of clinical research
•   Solid working understanding of clinical protocols, CRF’s and all other associated study documents
•   Demonstrated analytical and problem-solving skills; attention to detail
•   Strong interpersonal and collaboration skills with the ability to build and maintain positive relationships both internally and externally
•   Strong organizational skills with the ability to handle multiple tasks and deadlines
•   Excellent written and verbal communication skills
•   Ability to work effectively in a team setting
•   Advanced knowledge of Word, Excel and PowerPoint

What else should you know?
•   Infrequent travel, up to 5%, may be necessary in this role

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 hr@omeros.com or contact Omeros, asking for Human Resources, at (206) 676-5000.