Job Information
McLaren Health Care Scientific Medical Writer - McLaren Careers in Detroit, Michigan
Position Summary:
The Scientific/Medical Writer
plays a critical role in the development and execution of Karmanos Cancer Institute (KCI) oncology clinical research studies. The primary responsibility of this position is to create detailed clinical research protocols that outline the objectives, design, methodology, statistical considerations, and organization of a clinical trial. This role requires a combination of scientific knowledge, attention to detail, and excellent writing skills.
Responsibilities
:
Drafting Clinical Trial Documents: Develop comprehensive protocols for clinical trials, including study objectives, design, methodology, statistical considerations, and trial organization, as well as Informed Consent Forms for corresponding clinical trials.
Collaboration with KCI Research Investigators and/or Staff: Work closely with clinical researchers, statisticians, and other stakeholders to ensure the protocol aligns with the study goals and regulatory requirements.
Review and Revision: Regularly review and revise protocols based on feedback from team members and Institutional Review Board (IRB)/regulatory authorities to ensure accuracy and compliance.
Document Management: Maintain and update protocol documentation, ensuring all versions are accurately recorded and stored.
Regulatory Compliance: Ensure that all protocols comply with regulatory and ethical standards.
Qualifications:
Required:
Bachelor’s degree in a relevant field (e.g., life sciences, medical sciences, pharmacy, etc.).
Four years of experience in protocol writing and development, implementation or execution of investigator-initiated trials, pharmaceutical-funded studies, or multi-center clinical research trials.
Preferred:
Master’s degree in a relevant field (e.g., life sciences, medical sciences, pharmacy, etc.).
Six years of experience in protocol writing and development, implementation or execution of investigator-initiated trials, pharmaceutical-funded studies, or multi-center clinical research trials.
Experience in oncology clinical trial protocol writing and/or clinical research in an academic setting.