Sr. Research Protocol Specialist - Office of Clinical Trials - Remote
About the position
Responsibilities
• Independently manage the clinical trial development, maintenance, and completion process.
• Direct large, complex, multi-center, and investigator initiated clinical research protocols/programs.
• Coordinate the writing of protocol/clinical research documents.
• Manage pre-written protocol/clinical research documents through the clinical trial development/implementation process.
• Write informed consent documents.
• Coordinate study logistics/approvals and verify content to meet standards.
• Communicate with study sites, industry partners, and federal agencies.
• Develop clinical trial budgets.
• Provide consultative guidance regarding regulatory and policy requirements to physicians, study staff, and external sponsors.
• Work in a team environment and manage multiple projects at various stages.
• Participate on committees and lead projects as assigned.
• Write and develop standard operating procedures and working instructions.
• Educate and serve as an expert resource for other research personnel.
Requirements
• Master's degree with 2 years experience in the clinical research setting or related field.
• Bachelor's degree with at least 4 years of experience in clinical research or related field.
• Associate's degree with 6 years experience in the clinical research setting or related field.
• Proficient in the use of computers and Microsoft applications.
• Project management experience required.
• Proficient in research systems and leveraging tools and technology.
• Knowledgeable with regulatory documents, IRB submission, and writing consent forms.
Nice-to-haves
• Previous study start-up experience.
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