Sr. Research Protocol Specialist - Office of Clinical Trials - Remote
About the positionResponsibilities• 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 bolthires 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. Apply tot his job