Clinical Trial Associate/Sr. Clinical Trial Associate

Good things are happening at Omeros!

Come join our Clinical Development Group!

The Clinical Trials Associate (CTA) is responsible for performing in-house clinical trial administrative duties in support of the Clinical Development departmental objectives. This position requires prior experience or training in clinical research and GCP/ICH guidelines.Under general supervision, this person assists with the coordination of activities associated with the start-up, conduct, and close-out of clinical trials and other duties as assigned. Although, prior CTA experience is not required, a thorough knowledge of the clinical trials process and associated regulations, responsibilities and roles is required.

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?

• Collaborate with project team in the clinical study development process

• Assist in the development and editing of study-related materials

• Assist with planning, coordination and presentation of information at Investigators' meetings

• Assists with site management at the direction of other clinical personnel

• Assists the Clinical Team in providing support to the clinical sites and the clinical team members during the conduct of clinical trials

• Assists with the management and tracking of study projects through the use of the CTMS or other electronic means

• Independently produces meeting minutes

• Assists with management of investigational drug and study supplies by preparing and ensuring the accuracy of shipments of study-related materials (e.g., drug orders, study binders, clinical documents and spreadsheets)

• May participate in co-monitoring visits or other site visits based on experience and training provided by and under guidance of the sites' assigned CRA or designee

• Assists the CRA with the flow of data, including but not limited to facilitating CRF retrieval and query resolution under guidance of CRA or designee

• Assists with collection, review and filing of regulatory and other essential documents from clinical personnel (e.g. site trip reports) and sites (e.g. FDA 1572 forms)

• Assists with data query resolution process

• May assume a specialized administrative role (e.g., SOP Administrator, CTMS Administrator, TMF Administrator, etc…)

• For a Level 2: A 4-year degree from a university is preferred; however, a minimum combination of experience and training for 7 years will be taken under consideration

• For a Level 3: A 4-year degree from a university is preferred; however, a minimum combination of experience and training for 9 years will be taken under consideration

• For a Level 2: At least 2-5 years applicable experience preferred, in a scientific or medical field

• For a Level 3: At least 5 - 8 years applicable experience preferred, in a scientific or medical field

• Solid working understanding of clinical protocols, CRFs, and all other associated study documents

• Familiar with basic concepts of clinical research

• Advanced knowledge of Word, Excel and PowerPoint

• Knowledge of the principles and practices of computer applications in database management

• Must have a high degree of customer focus towards internal and external stakeholders

• Strong interpersonal and collaboration skills

• Clear and concise verbal and written communication skills

• Able to handle multiple tasks and deadlines.

• No personnel would report directly to this position.

• The employee may frequently be performing repetitive movements such as typing on a keypad or using a mouse.
• The employee may occasionally climb or balance, stoop, kneel, or crouch

• The employee must on occasion lift and/or move up to 25 pounds.

• Infrequent travel may be necessary

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.