Clinical Trial Associate/Sr. Clinical Trial Associate

Clinical Trial Associate/Sr. Clinical Trial Associate

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 are required. 

Essential Duties & 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…)

Education, Experience, Knowledge, & Skills Required:

• BS/BA degree is preferred or dependent on the level, a minimum combination of experience and training will be taken into consideration
• A minimum of 1 – 5 years of experience in a scientific medical field is required for a Clinical Trial Associate and 5 – 12 years of experience in a scientific medical field is required for a Sr. Clinical Trials Associate

• 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
• Strong interpersonal and collaboration skills
• Clear and concise verbal and written communication skills
• Demonstrated ability to handle multiple tasks and deadlines

Behavioral Competencies Required: 

• Must have a high degree of customer focus towards internal and external stakeholders
• Demonstrated ability to build and maintain positive relationships with management, peers, and subordinates

Other Requirements:

• Infrequent travel may be necessary

Physical Demands Required: 

• 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

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