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Senior Clinical Trial Coordinator

Req ID:  3758

Working Location: WASHINGTON, REDMOND 

 

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. 
 
Let’s inspire healthier lives, together.

Job Description

The Senior Clinical Trial Coordinator (SCTC) is responsible for the coordination and administration of clinical trials under the direction of the Dir. Clinical Projects. The SCTC will develop, implement, and coordinate study and administrative procedures for the successful management of clinical trials. The SCTC will perform diverse administrative duties requiring analysis, sound judgment, attention to detail, and a high level of knowledge of study specific protocols. The SCTC will take on additional leadership responsibilities including onboarding, training, and mentorship of more junior Clinical Affairs team members. The SCTC will help organize responsibilities for more junior Clinical Affairs team members working directly with the Dir. Clinical Projects.

Job Duties

* Coordinates and supports activities for multiple studies under the direction of the Dir. Clinical Projects.

 

* Assists Clinical Affairs team with development of study specific documents.

 

* Responsible for set-up, maintenance, and archival of the Trial Master File (TMF).

 

* Collects and tracks regulatory documents for multiple studies to ensure completeness of TMF and audit readiness.

 

* Supports drafting of Clinical Trial Agreement (CTA), budget, and requests study specific Confidential Disclosure Agreements (CDA).

 

* Creates study specific Regulatory Binder and ships to clinical sites.

 

* Manages all aspects of study specific payments (e.g. vendors, sites) in accordance with executed agreements and approved budgets.

 

* Tracks payments and expenses against the department’s budget and regularly interfaces with Finance Department on study accruals.

 

* Communicates with principal investigators, hospital research, and legal staff to coordinate execution of a study.

 

* Provides support for study specific meetings (e.g. investigator, core teams, data safety monitoring board (DSMB)), drafts and circulates meeting minutes.

 

* Assists in remote and/or on site study monitoring.

 

* Assists Clinical Affairs team with site training (e.g. onsite or remote) to electronic data capture (EDC) system or protocol as needed.

 

* Designs and updates study specific newsletters and circulates final document to sites.

 

* Responsible for study device/equipment shipments, accountability, and reconciliation.

 

* Maintains Sunshine Act reporting records for assigned studies and reports updates to the Olympus Transparency Reporting team as needed.

 

* Ensures compliance to applicable clinical study regulations and Olympus SOPs, WIs, and policies.

Job Requirements

REQUIRED QUALIFICATIONS: 

 

Associates or Bachelor’s degree in a scientific, healthcare, or business related field is preferred.

 

* Must have a minimum of one year of experience working for a medical device/biotech/ pharmaceutical company, preferably in a Medical Affairs-related function.

 

* Ability to travel up to 10% of the time.

 

PREFERRED QUALIFICATIONS:

 

* Ability to support multiple projects for Olympus Clinical Affairs teams at different locations.

 

* Well organized, detail oriented, and accountable.

 

* Flexible, self-motivated, and works well under pressure in a dynamic environment. 

 

* Proficiency with Microsoft Office and electronic data capture (EDC) systems.

 

* Some experience organizing and analyzing data preferred.

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.

Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.

Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,500 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.
 

Olympus…True to You. True to Society. True to LIFE.

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Posting Notes: || United States (US) || Washington (US-WA) || Redmond || 


Nearest Major Market: Seattle
Nearest Secondary Market: Bellevue

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