Sr. Clinical Trial Associate

Job Posting

Sr. Clinical Trial Associate

Sr. Clinical Trial Associate

The Sr. Clinical Trials Associate (Sr. CTA) is responsible for performing in-house clinical trial administrative duties in support of the Clinical Development departmental objectives. This role assists with the coordination of activities associated with the start-up, conduct, and close-out of clinical trials and other duties as assigned. This is an intermediate role and is seen as a subject matter expert (SME) on one or multiple topics. In this role, you will support one or two projects (varies depending upon size, stage, and complexity) with limited direction.

Good things are happening at Omeros!

Come join our Clinical Operations Team!

Essential Duties & Responsibilities:

• Other duties may be assigned as required
• 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
• Assist in the development and editing of study-related materials
• Assists with the management and tracking of study projects using the CTMS or other electronic means
• May assume a specialized administrative role (e.g., SOP Administrator, CTMS Administrator, TMF Administrator, etc.)
• 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)
• Collaborate with project team in the clinical study development process
• Assist with planning, coordination and presentation of information at Investigators’ meetings
• May oversee and mentor others
• Assists with data query resolution process
• 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)
• Assist the CTM with Sponsor oversight of CRO-held eTMFs periodic audit and findings resolution
• Assists with site management at the direction of other clinical personnel
• Attend internal and external team meetings/teleconferences and generate meeting agenda and minutes when needed
• Assists the Clinical Team in providing support to the clinical sites and the clinical team members during the conduct of clinical trials
• May participate in Sponsor Oversight visits or other site visits based on experience and training provided by and under guidance of the sites’ assigned CRA or designee

Education, Experience, Knowledge, & Skills Required:

• A 4-year degree from a university is preferred
• Experience functioning in a CTA capacity for 2-4 years; a minimum of 5-8 years applicable experience preferred, in a scientific or medical field
• Previous CTA experience working with CROs and vendors
• Demonstrated ability to handle multiple tasks and deadlines
• Clear and concise verbal and written communication skills
• Experience and knowledge of ICH GCP and eTMF management
• Strong interpersonal and collaboration skills
• Demonstrated experience working effectively in a fast-paced team environment

Behavioral Competencies Required:

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

Other Requirements:

• Infrequent travel may be necessary

Physical Demands Required:

• Intermittent physical activity including bending, reaching, pushing, pulling, or lifting up to 20 lbs.
• May encounter prolonged periods of sitting or standing

Compensation and Benefits:

Omeros is proud to offer a competitive total compensation package designed to support the lives of our employees and their families. The wage scale for the Sr. CTA is $75,000 to $90,000 per year. Salaries will be determined based on knowledge, skills, education and experience relevant to the role. Employees are offered medical, dental, vision and life insurance and a 401k plan with a company match. Employees accrue three weeks of vacation and 80 hours of sick time on an annual basis and receive ten paid holidays throughout the calendar year. This position is eligible for bonus and stock options. To learn more about Omeros, please visit www.omeros.com.

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 protected] or contact Omeros, asking for Human Resources, at (206) 676-5000.