Job Summary:

Are you ready to be part of a close-knit clinical trial team that is passionate about saving the lives of patients? Then look no further - we would like to help you take your career to the next level!

Our Clinical Support Specialists contribute to the successful delivery of exciting advancements in therapies for patients across the globe. From the beginning, we have nurtured a culture where patients` needs and the needs of our valued clients come first, where the quality of our work is the best, and where our employees can thrive, while still having fun and giving back to the patient community. Precision`s diverse teams bring together individual thoughts and unique ideas to provide a best-in-class client experience; every voice matters and contributes to reaching client goals.

Our employee culture centers around individual growth and helping people drive their career, enjoy coming to work each day with balance - and not feel like a number. Discover your foundational opportunities within Precision for Medicine.

About the role:

• 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

Qualifications:
Minimum Required:

• Graduate of a secondary education or equivalent degree
• Minimum of 6 months to 6 years of clinical research experience, depending on level

Other Required:

• 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

About Precision for Medicine
Precision medicine is revolutionizing the attack on cancer-and we are passionate about helping our clients harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions-and optimize the oncology development pathway.