Olympus America Inc. Senior Clinical Research Associate in Redmond, Washington
As a Senior Clinical Research Associate working on the Clinical Affairs team, you will be empowered and inspired to do your best work. You will contribute to our mission by managing committee preparation, adverse event reporting, and study correspondence. A typical day for you will include:
Serving as a key representative between the company, clinical sites, clinical field staff, CROs and provide back up, in-house coverage for CFSs.
Fielding clinical site and CRO questions and issues in regard to specific study operations including protocol, safety, and compliance issues; providing guidance on documenting AEs and protocol deviations; ensuring sites submit appropriate source documentation of AEs according to protocol requirements; and enter accurate and complete data into the Spiration AE database.
Acting as primary contact for internal/external trial representatives for Adverse Event (AE) and protocol compliance activity.
Tracking and preparing all AE and protocol compliance documentation in support of FDA reports, and CEC and DSMB meetings.
Ensuring AEs are reported to Spiration in accordance to study requirements.
Tracking monitoring activity and ensure safety issues are adequately documented in monitoring visit reports.
Creating and modifying guidelines for AE CRFs as required.
Preparing draft CEC Meeting books and minutes.
Ensuring accurate documentation of CEC and DSMB meetings update AE database information after meetings, and communicate with clinical sites and CRO/CRAs (Clinical Research Associates) to adjudicate AEs.
Tracking study progress related to protocol compliance and AE reporting procedures at clinical sites through monitoring reports and regular communication with field CRAs, CFSs and site representatives.
Providing central support to Clinical Operations group, which includes:
Participating in and address agenda topics during regularly scheduled calls and meetings with staff, sites, and CROs, and clinical vendors.
Monitoring related activity, review periodic reports for potential problems, provide clinical support and communicate with field representatives regarding outstanding issues.
Assisting the Clinical Project Manager with study operations, which could include:
Communicating with Project Managers, CFSs, and CRAs in regards to visit issues, site issues and/or study and protocol questions.
Training field personnel on processes for AE reporting and maintenance of the clinical trial master file.
Tracking protocol deviations and violations in conjunction with Data Management group; tracking deviation/violation trends and provide guidance to site personnel, CFSs and CRAs on deviation/violation issues and questions; ensuring accurate reporting of deviations/violations through monitoring processes and documentation in visit reports; closing deviations/violations with the Clinical Operations department and ensure corresponding action items are resolved.
Working with Regulatory and Medical Affairs to help prepare clinical study reports and other publications or submissions including FDA reports and CEC and DSMB materials.
Initiating and implementing refinement of the clinical study adverse event database, data entry activities and data handling procedures, study protocols and processes, case report forms, trial reference materials and instruction manuals, subject CRF binders and clinical standard operating procedures.
Maintaining organized adverse event, protocol deviation/violations, CRO activity and monitoring files for clinical sites including paper and electronic files.
Providing oversight and/or guidance related to master files for clinical studies.
Maintaining a high level of professional expertise through familiarity with new developments in clinical literature.
Bachelor's Degree is required; preferably in Life Sciences or Medical discipline.
Minimum of 8 years of experience coordinating and/or monitoring clinical trials in a health care or medical industry environment required.
Ability to work overtime, including evenings on occasion.
Travel as required, approximately 10% (domestic and international).
Professional CRA certification.
Knowledge of clinical research and clinical protocols for human studies.
Knowledge of clinical studies involving medical devices.
Working knowledge of Good Clinical Practices (GCPs).
Regulation and guidance documents, and other applicable regulations and standards as appropriate.
Knowledge and experience with Spiration quality system procedures.
Excellent interpersonal skills.
Strong organizational skills.
Effective negotiation and problem solving skills.
Proven track record of self-motivation.
High level of proficiency in Microsoft Word, Outlook, Excel and PowerPoint.
Microsoft Visio skills are desired.
Superior writing, composition, English grammar skills.
Proven record of consistently following through on commitments.
Ability to maintain and communicate realistic schedules and meet or beat deadlines.
Service oriented approach, flexible and proactive towards changing needs.
Exceptionally team focused and actively contributes to a positive and innovative work environment.
Proven ability to work on assignments that are complex and sensitive in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
Ability to work precisely according to procedures, rules and regulations, has a passion for continuous improvement and quality.
Ability to demonstrate the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside the Company.
We realize work isn’t just a job to you.
It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.
At Olympus, we put a lot of good back into the world, and what we do really matters. We are committed to making people’s lives healthier, safer and more fulfilling every day by crafting innovative optical and digital solutions in medical technologies, microscopy, industrial solutions, cameras, and audio recorders.
We view our relationship with and commitment to our employees with the same passion. Everything we do at Olympus is a reflection of our vision, and everyone here helps to make it a reality. We’re invested in our employees, great ideas, and how they impact the communities around us. We see the world through multiple lenses and come together to find the right answers; the best solutions.
TRUE TO YOU. TRUE TO SOCIETY. TRUE TO LIFE.
Olympus embraces diversity and inclusion. As an Equal Opportunity Employer, our policies as well as our values prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification. EOE Minorities/Females/Veterans/Disabled
Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day. We’re currently looking for a Sr. Clinical Research Associate to join us in our Redmond, WA office.
Let’s inspire healthier lives, together.
The Sr. Clinical Research Associate provides the Clinical Operations team support in the areas of Adverse Events (AE) management, study- related committee meeting prep and planning, study-related communication, reports and publications, and provides back-up and support for Clinical Field Specialists (CFS) and occasionally, the Clinical Project Manager.
Olympus Respiratory at http://www.olympusrespiratory.com/
Senior Clinical Research Associate
Redmond, WA ORA
Auto req ID:
Olympus is an Equal Opportunity Employer, and our policies prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification.