Oncology Clinical Research Specialist
2 weeks ago
Position Overview:
As a Clinical Research Scientist at Katalyst HealthCares & Life Sciences, you will play a pivotal role in collaborating with various project team members, including Clinical Research Physicians, Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory Affairs, and Project Management.
Key Responsibilities:
- Collaborate with the Clinical Research Scientist team to ensure effective communication with project stakeholders.
- Conduct thorough reviews and inquiries of oncology and hematology data, focusing on safety, primary efficacy variables, and laboratory results.
- Assist in the preparation of clinical documents, including writing, reviewing, and facilitating amendments across functions.
- Contribute to the development of clinical study reports, including narrative writing.
- Participate in ad-hoc meetings as necessary.
- Provide support for clinical trial activities as required.
Essential Skills and Knowledge:
- A minimum of 10 years of experience in oncology and hematology clinical development.
- Exceptional written and verbal communication skills, along with strong interpersonal abilities.
- Comprehensive understanding of clinical trial design, basic statistics, and data review methodologies.
- Proficient in data analysis and interpretation.
- Experience in protocol development, study report writing, Investigator Brochure preparation, and regulatory submissions.
- In-depth knowledge of GCP and ICH Guidelines.
- Detail-oriented and highly organized.
- Ability to quickly assimilate technical and scientific information.
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint; familiarity with Microsoft Project is a plus), JReview, and EDC systems (Rave).
- Proven ability to work collaboratively within a team environment.
- Experience in oncology/hematology is required; registry experience is a plus. Familiarity with protocol authoring and data review/medical monitoring is essential.
Qualifications:
- An advanced degree in Life Sciences (e.g., nursing, pharmacy, or a related medical field) with a minimum of 10 years of experience in clinical research development or an equivalent background.
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