Precision Medicine Group ยท 5 months ago
Join Our Talent Community - Clinical Support Specialist
Precision Medicine Group is a company focused on revolutionizing cancer treatment through precision medicine. They are seeking a Clinical Support Specialist to contribute to clinical trial teams, supporting site start-up activities and ensuring the successful delivery of advancements in therapies for patients.
BiotechnologyHealth Care
Responsibilities
May support teams with feasibility and investigator recruitment efforts
Support or drive site start up activities such as:
Planning of site level milestones to allow timely site activation
Work within the forecasted submission/approval timelines
Perform review, validation, tracking and filing of essential documents for investigational sites as well as follow-up on missing/incomplete/invalid documents
Informed Consent review
Prepare and submit Central EC applications, support site completion of Local EC applications or other supplemental submissions such as hospital approval submissions, as required
Ownership of eTMF and management of eTMF study mailboxes
Creating, maintaining and closeout for the most critical client deliverable, TMF
Providing administrative support to the project team for study related activities such as:
Team training maintenance
Working with study supply and site binder vendors
Providing meeting minutes
CSSs may support the development and mentoring of junior CSSs
Qualification
Required
Graduate of a secondary education or equivalent degree
Minimum of 6 months to 6 years of clinical research experience, depending on level
Experience and fluency in the Microsoft Office package of programs (Outlook, Word, Excel and PowerPoint)
Customer service demeanor; demonstrate flexibility, teamwork, and a keen attention to detail
Ability to speak English proficiently (professional level)
Ability to travel domestically and internationally including overnight stays
Company
Precision Medicine Group
We founded Precision Medicine Group in 2012 because we believed there was a transformational opportunity to improve the process of bringing new drugs to market.