Clinical Trial Specialist/Sr. Clinical Trial Specialist
The Clinical Trial Specialist (CTS)/Senior Clinical Trial Specialist (Sr. CTS) is responsible for providing operational support for the day-to-day execution of clinical trials, and follows established SOPs, GCP and other applicable regulatory requirements in the execution of all activities, to proactively identify and resolve operational project issues, and participate in process improvement initiatives as required.
Good things are happening at Omeros!
Come join our Clinical Operations Group!
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?
- Ensuring timely and accurate study-related communication to clinical personnel including internal and external study teams, consultants and investigative site personnel by preparing and disseminating clinical trial correspondence, newsletters, etc., and assisting with creating study-specific manuals, tools, and templates.
- Participating in the selection and management/oversight of external vendors, developing vendor specifications, reviewing vendor reports, budgets, and metrics, and acting as the liaison between vendors and sites
- Coordinating clinical trial meetings such as investigator meetings, study team meetings, and CRA/CRO meetings
- Setting-up, tracking, and maintaining audit-ready clinical trial documentation and study status in our clinical trial management system as well as generating, reviewing and distributing reports, and assisting with quality assurance audits and the resolution of audit findings
- Participating in study design and execution by contributing operational experience and expertise
- Participating in site monitoring visits, posting and maintaining study-related information on external websites
- Ensuring that necessary study supplies are available including sourcing clinical trial supplies through external vendors (such as Case Report Forms, Study Manuals, lab kits, etc.)
- Managing, reviewing and tracking drug shipment, destruction, and return, and coordinating internal lab sample supply set up and shipment
- Serving as a liaison and resource for investigational sites
What experience and education do you need?
You will need a BS degree or equivalent combination of education and experience in a science or a health-related field. Dependent on the level, you’ll need a minimum of 3 – 5 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. Additional we are seeking the following:
- Global clinical trial experience
- CTMS experience
What skills, knowledge and abilities does our ideal candidate have?
As our ideal candidate, you will need the following skills, knowledge and abilities:
- Familiarity with advanced concepts of clinical research with the ability to work effectively in a team/matrix environment
- Knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH GCP guidelines
- 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
- Excellent communication skills, both verbal and written, as well as strong analytical and problem-solving skills
- Excellent interpersonal skills, with the ability to build and maintain positive relationships with management and co-workers
- Strong organizational skills along with the ability to prioritize, strong analytical and problem-solving skills, and attention to detail
- Demonstrated ability to deal with time demands, incomplete information or unexpected events
- The ability to proactively identify and resolve or refer project-related operational issues
What else do you need to know?
- Ability to travel approximately 20% (50% or greater during peak times); may require overnight travel
If you have the skills, knowledge and experience we are looking for, we’d love to hear from you!