About Us
McLaren Health Care is a fully integrated health network committed to quality, evidence-based patient care with locations in Michigan and Indiana. The McLaren system includes 13 hospitals in Michigan, ambulatory surgery centers, imaging centers, a primary and specialty care physician network, commercial and Medicaid HMOs, home health, infusion and hospice providers, pharmacy services, a clinical laboratory network and a wholly owned medical malpractice insurance company. McLaren operates Michigan’s largest network of cancer centers and providers, anchored by the Karmanos Cancer Institute, one of only 53 National Cancer Institute-designated comprehensive cancer centers in the U.S.
Scientific Medical Writer
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.
Equal Opportunity Employer
McLaren Health Care is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identification, age, sex, marital status, national origin, disability, genetic information, height or weight, protected veteran or other classification protected by law.
