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Clinical Research Scientist
2 months ago
Job Title: Clinical Research Scientist
Location: Remote/Onsite
Duration: Long-term Contract
Shift: Day Shift
Key Responsibilities:
- Contribute to the Systemic Mastocytosis portfolio and the BLU 808 clinical trial.
- Collaborate with Medical Directors, Pharmacology teams, Discovery departments, external specialists, and research investigators to gather essential scientific and medical insights to inform clinical development strategies and study designs.
- Support Medical Directors in drafting proposed concept sheets for clinical trials and assist in writing protocols and informed consent documents by integrating feedback from both internal and external stakeholders.
- Participate in the annual update of the Investigator's Brochure with contributions from Toxicology, Pharmacology, Safety, and Regulatory teams, ensuring clinical insights are included in responses to regulatory inquiries and submissions.
- Review and monitor safety and efficacy data in ongoing studies alongside the medical monitor; ensure compliance with Good Clinical Practice (GCP) in collaboration with clinical operations and Contract Research Organizations (CROs).
- Engage in high-level data validation activities that require clinical judgment and contribute to the analysis of complex data for regulatory submissions, publications, and study design.
- Attend scientific conferences to stay updated on advancements in relevant fields and foster relationships with investigators and advisors.
- Assist investigative sites by addressing protocol-related inquiries and resolving issues related to study conduct and design.
- Present findings, protocol designs, and other relevant information at advisory boards, investigator meetings, site initiations, and various internal and external forums.
Qualifications:
Master's, PhD, or PharmD in a relevant discipline.
Required Skills:
Experience in Allergy, Hematology, and Oncology within a clinical environment.
Language Proficiency:
Fluent in English (Speaking, Reading, Writing).
