Clinical Study Associate II
At Blueprint Medicines, as our name indicates, we are creating a blueprint for the future of healthcare. We are a leading company in the personalized medicine revolution by focusing on delivering new medicines that are targeted to the genetic driver of disease. We do this by leveraging our one-of-kind drug discovery platform to discover, develop and work to bring highly-selective kinase inhibitors to patients globally. This prolific scientific platform has enabled Blueprint Medicine to build a pipeline of novel therapies that span three distinct areas of medicine; genomically defined cancers, rare diseases and cancer immunotherapy.
This position reports into the Senior Clinical Program Manager of Clinical Operations. The right candidate will possess a basic understanding of Clinical Operations processes related to clinical trial execution.
Responsibilities of this position involve the day to day management and oversight of clinical trials in collaboration with a dynamic Clinical Development team.
- Participates in the day to day supervision of clinical trial execution, with a focus on site start up, patient enrollment, monitoring, and data flow metrics from the clinical sites, CROs and central labs
- Supports complex clinical trial activities in support of the Clinical Study Manager and other team members
- Prepares study documents (i.e. consent forms, site instructions, study specific materials such as the Manual of Operations, Pharmacy binder, etc.)
- Ensures tracking of essential documents are received and filed in the TMF, reviews site documents for accuracy; provides clinical team support with TMF filing and management
- Ensures tracking of patient status throughout the study at investigative sites
- Tracks and monitors sample collection, central laboratory reporting, and manages laboratory testing schedule
- Assists with laboratory vendor management and liaises with the CRO and clinical trial sites to ensure appropriate sample handling, shipment and result reporting
- Assists in reviewing monitoring trip reports, track data query reports, site visit metrics, and overall site performance
- Attends site visits as necessary including: site initiation visits, routine monitoring and close-out visits at a limited # of clinical sites, as well as co-monitoring with CRO
- Ensures quality of the data generated from clinical sites and assists in resolving subject eligibility and protocol deviation issues
- Assists in the preparation of, and may present at investigator vendor meetings and workshops
- Coordinate the activities from third party vendors including metrics, accruals, process planning, and implementation
- Bachelors’ degree or higher
- 2 or more years industry, or clinical research experience in a pharmaceutical, CRO, or clinical research site environment
- Working knowledge in Good Clinical Practices (GCP) regulations and Standard Operating Procedures
- Understanding of study phases and general knowledge of how they apply to clinical development
- Advanced knowledge of Word, Excel, and PowerPoint.
- Knowledge of the principles and practices of computer applications in database management
- Strong verbal and written communication skills.
All applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.
WHO WE ARE:
Blueprint Medicines’ mission is to dramatically improve the lives of patients with genomically defined diseases. Our singular focus is to use our deep understanding of the genetic blueprint of cancer and other diseases driven by the abnormal activation of kinases to craft highly selective medicines aimed at eradicating these diseases.
We don’t think in small steps. We think in giant leaps.
We are driven by the pursuit of new ideas, new innovations, and new ways of thinking.
We know that what each and every one of us does matters and that our success depends on our ability to work together. We believe we are at our best as a company when our employees are thriving and foster a culture that provides opportunities to grow and develop professionally, while also having fun.