Clinical Trial Specialist/Sr. Clinical Trial Specialist

Location
Seattle
Posted
Sep 03, 2020
Ref
1774
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time
The (Sr.) Clinical Trial Specialist (CTS) is responsible for providing operational support for the day-to-day execution of clinical trials, follow established SOPs, GCP and other applicable regulatory requirements in the execution of all activities, proactively identify and resolve operational project issues, and participate in process improvement initiatives as required. This person is able and willing to perform all duties or functions of subordinates. The core duties and responsibilities of the (Sr.) CTS are delineated below.

Come join Omeros!

Come join our Clinical Deveopment 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 intraocular solution) 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.

Primary Responsibilities:

  • Ensures timely and accurate study-related communication to clinical personnel (i.e., internal and external study teams, consultants and investigative site personnel): prepares and disseminates clinical trial correspondence, newsletters, etc. (working with project clinician), and assists with creating study-specific manuals, tools, and templates
  • Participate in selection and management/oversight of external vendors and develop vendor specifications; review vendor reports, budgets, and metrics; acts as liaison between vendors and sites (e.g., assists site with laboratory sample queries)
  • Coordinate specified clinical trial meetings (e.g., investigator meetings, Study team meetings, CRA and CRO meetings) by arranging logistics, preparing necessary materials and recording and distributing minutes
  • Set-up, track, and maintain audit-ready clinical trial documentation and study status in clinical trial management system: manage and track regulatory/IRB/EC documentation, IND Safety Letter distribution, Confidentiality Disclosure Agreements, and other clinical trial documents; generate, review and distribute reports; assist with quality assurance audits and resolution of audit findings
  • Participate in study design and execution by contributing operational experience and expertise: provide input into protocol, ICF, CRF design, monitoring conventions, edit checks and vendor specifications; assists with study or site feasibility process; participate in site monitoring visits, as appropriate; post and maintain study-related information on external websites when applicable
  • Ensure that necessary study supplies are available as per study timelines: source clinical trial supplies through external vendors (such as Case Report Forms, Study Manuals, lab kits, etc.);
  • Manage, review and track drug shipment, destruction, and return; coordinate internal lab sample supply set up and shipment
  • Serve as a liaison and resource for investigational sites
  • Carry out supervisory responsibilities in accordance with company policies and applicable laws
  • Interview, hire and train employees
  • Plan, assign and direct work
  • Appraise performance
  • Supervise work in a matrix organization
  • Bachelor's degree or equivalent combination of education/experience in science or health-related field required
  • These are positions in the Clinical Operations career path. The CTS will have at least 3 years clinical monitoring experience or a similar duration of experience with a combination of monitoring and clinical project management, study coordinator, data management, site monitoring and/or nursing experience. The Sr. CTS will have at least 5 years of similar experience
  • Familiar with advanced concepts of clinical research and able to work effectively in a team/matrix environment
  • Knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH GCP guidelines, is required
  • Able to deal with time demands, incomplete information or unexpected events
  • Knowledge of the principles and practices of basic computer applications used in general office setting, including word processing, spreadsheet, database management, presentation software and Internet search engines. CTMS experience preferred
  • Global clinical trial experience preferred
  • Excellent communication (verbal and written) and interpersonal skills. Clear and timely communication
  • Ability to build and maintain positive relationships with management, peers, and subordinates
  • Ability to handle a moderate volume of highly complex tasks within a given timeline
  • Proactively identify and resolve/refer project-related operational issues; ability to work independently on routine assignments, or under supervision on new assignments
  • Strong organizational skills and ability to prioritize
  • Strong analytical and problem solving skills
  • Excellent attention to detail
  • Able to travel approximately 20% overnight (50% or greater during peak times). May require overnight travel
  • May frequently perform repetitive movements such as typing on a keypad or using a mouse
  • May occasionally climb or balance, stoop, kneel, or crouch
  • May occasionally be required to 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.