Clinical Study Associate I

Clinical Study Associate I Cambridge, MA Requisition Number: 24-604 How will your role help us transform hope into reality? Coordinate and provide key scientific support of the day-to-day management of clinical trials and trial data for the development of new drugs, focusing on clinical trial site start-ups, new patient enrollment, and monitoring data flow metrics from the clinical sites to support the overall management of the Clinical Operations team.

What will you do? Apply scientific understanding of pediatric rare diseases to execute complex clinical trials globally. Coordinate the day-to-day execution of clinical trials, with a focus on site start-up, patient enrollment, monitoring, and data flow metrics from clinical sites, clinical research organizations (CROs), and central labs.

Support complex clinical trial activities in support of the Clinical Study Manager and other team members. Collaborate with stakeholders internally and externally with the key opinion leaders (KOLs). Strategize and foster recruitment and retention of patients of diverse and marginalized backgrounds. Prepare and present clinical study documents, including consent forms, site instructions, study-specific materials such as the manual of operations, and a pharmacy binder.

Manage clinical trip reports, track data query reports, site visit metrics, and overall site performance; attend clinical site initiations and conduct routine monitoring and close-out visits; facilitate clinical study feasibility assessments. Prepare and present clinical research documents for investigator vendor meetings and workshops; coordinate the activities from third-party vendors including metrics, accruals, process planning, and implementation. Review data generated from clinical sites to provide resolutions to subject eligibility and protocol deviation issues; ensure GCP standards compliance in all study activities, including monitoring and documentation.

Interpret and apply regulatory requirements, collaborate with authorities, and stay updated on relevant guidelines for ongoing trial adherence. Oversee contract negotiation and compliance with CRO, vendors, and sites. Utilize knowledge of clinical data research methods, such as Trial Master File ("TMF") to track critical clinical research documents and ensure proper recordkeeping and filing according to federal and global regulatory standards.

Monitor sample collection, oversee central laboratory reporting, and manage laboratory testing schedules; ensure appropriate sample handling, shipment, and result reporting by managing and coordinating efforts between the vendor CRO and clinical trial sites. What minimum qualifications do we require? Position Requirements:

Bachelor's degree in Biology, Neuroscience, Clinical Trials Management, or a closely related field (or foreign equivalent degree), plus 2 years of experience in pediatric rare disease clinical trial operations in a pharmaceutical, CRO, or clinical research site (e.g., academic hospital) environment. Experience, which may be gained concurrently, must include: 2 years of experience working with diverse patient populations in pediatric clinical trials. 2 years of applying working knowledge in ICH/GCP, regulatory requirements, and Standard Operating Procedures to coordination of clinical trials and trial data. 1 year of experience in Budget and Contract Management for clinical trials. 2 years of experience with clinical trial and clinical data systems (EDC, electronic medical records), EMR, CTMS. Proficient in clinical research coordination.

What additional qualifications will make you a stronger candidate? Commitment to our Core Values: Patients First, Thoughtfulness, Urgency, Trust, Optimism Why Blueprint?

At Blueprint Medicines, we achieve impactful results because of our global crew of compassionate innovators - the Blue Crew. Through authentic relationships and our collective entrepreneurial spirit and action, we are each empowered to take ownership and execute with strategic prioritization. We put trust in our people to break through norms and conventions using their individual strengths and insights, which drives our success.

This is the place where the extraordinary becomes reality, and you could be part of it. Patients are waiting. Are you ready to make the leap?

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 TotalRewardsblueprintmedicines.com. For more information, please see our EEO-AA Policy Statement, the EEO Know Your Rights Poster, as well as our Pay Transparency Statement.

Blueprint Medicines is a global, fully integrated biopharmaceutical company that invents life-changing medicines. We seek to alleviate human suffering by solving important medical problems in two core focus areas: allergy/inflammation and oncology/hematology. Our approach begins by targeting the root causes of disease, using deep scientific knowledge in our core focus areas and drug discovery expertise across multiple therapeutic modalities.

We have a proven track record of success with two approved medicines, including bringing our medicine to patients with systemic mastocytosis (SM) in the U.S. and Europe. Leveraging our established research, development, and commercial capability and infrastructure, we now aim to significantly scale our impact by advancing a broad pipeline of programs ranging from early science to advanced clinical trials in mast cell diseases including SM and chronic urticaria, breast cancer and other solid tumors. This position is part of Blueprint Medicines' employee referral program and is eligible for an employee referral incentive bonus. LI-DNI