Clinical Study Associate II

Clinical Study Associate II
Cambridge, MA
Requisition Number: 300

How will your role help us transform hope into reality?
You will support our Clinical Operations Study Leader and the study team in day-to-day management and oversight of clinical trials.
What will you do?

• 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
• Review monitoring trip reports, track data query reports, site visit metrics, and overall site performance
• Attends site initiation, 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
• Actively involved in the performance of study feasibility assessments
• Coordinate the activities from third party vendors including metrics, accruals, process planning, and implementation

What minimum qualifications do we require?

• Bachelors’ Degree or higher
• 2 years of experience in 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
• Experience in monitoring, study coordination, and or clinical data handling

What additional qualifications will make you a stronger candidate?

• Resourcefulness/Flexibility – The ability to adapt to working optimally within a variety of situations
• Organization – The ability to keep many different activities, information, deadlines and progress tracked and communicated to team members.
• Multi-tasking – You'll be asked to participate in a variety of different activities often concurrently.
• Team Collaboration – You'll be participating in a dynamic, global team environment, so being a team-player is crucial to this role.
• Strong verbal and written communication skills.
• Commitment to our Core Values: Patients First, Thoughtfulness, Urgency, Trust, Optimism

COVID-19 Vaccination Requirement
As a biotechnology organization, it is our responsibility to do everything we can to safeguard the health and safety of our workforce, our communities, and the patients we serve. That is why, prior to their start date, new hires must provide confirmation that they are fully vaccinated against COVID-19, or be approved by Blueprint for an exemption for health reasons contraindicating the vaccines or sincerely held religious beliefs. Accommodation requests for either of these reasons should be made to TotalRewards@blueprintmedicines.com.
Equity, Diversity, Inclusion and Affirmative Action
At Blueprint Medicines, we foster a culture of equity, diversity and inclusion. A proud Equal Employment Opportunity and Affirmative Action employer, we consider all qualified applicants without regard to race, color, sex, gender identity or expression, sexual orientation, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, or any other characteristic protected under applicable law. We are also an E-Verify Employer. We will make reasonable accommodations, absent undue hardship, for qualified individuals with known disabilities. If you are an individual with a disability in need of an accommodation with the application or recruiting process, please reach out to TotalRewards@blueprintmedicines.com.
For more information, please see our EEO-AA-Policy-Statement , the EEO Poster and its Supplement , as well as our Pay Transparency Statement .
Blueprint Medicines is a global precision therapy company that invents life-changing therapies for people with cancer and blood disorders. Applying an approach that is both precise and agile, we create medicines that selectively target genetic drivers, with the goal of staying one step ahead across stages of disease. Since 2011, we have leveraged our research platform, including expertise in molecular targeting and world-class drug design capabilities, to rapidly and reproducibly translate science into a broad pipeline of precision therapies. Today, we are delivering approved medicines directly to patients in the United States and Europe , and we are globally advancing multiple programs for systemic mastocytosis, lung cancer and other genomically defined cancers, and cancer immunotherapy. For more information, visit www.BlueprintMedicines.com and follow us on Twitter (@BlueprintMeds) and LinkedIn .

Job Type: Full-time