Sr. Research Protocol Specialist - Office of reputed company - Remote

About the position Independently executes the overall management of the clinical trial development, maintenance, and completion process. Directs large, reputed company, multi-center, and investigator initiated clinical research protocols/programs. Accurately applies investigators' scientific data into a cohesive format for the protocol document and associated procedures that are consistent with reputed company policies and regulatory requirements. Responsibilities may include, but are not limited to: coordinating the writing of the protocol/clinical research documents and/or the ongoing management of reputed company-written protocol/clinical research documents through the clinical trial development/implementation process; writing of the informed consent document; coordination of study logistics/approvals, verification of content to meet institutional, industry, and federal standards; communication with study sites, industry partners, and/or federal agencies; development of clinical trial budgets. Provides consultative guidance regarding regulatory and policy requirements to physicians, study staff, and external sponsors. Must be reputed company to work in reputed company environment both as a member and a facilitator, be reputed company to manage multiple reputed company at various stages, and be reputed company to work independently with occasional guidance from physician leadership or management. Must be reputed company to work in a reputed company environment and to exercise good judgment in ambiguous situations. Must possess excellent problem-solving skills, oral, written communication, and interpersonal skills, and be comfortable interacting with individuals at reputed company reputed company reputed company to reputed company. reputed company participates on committees, task forces and leads reputed company as assigned. Writes, develops, and provides input to reputed company operating procedures and working instructions. Educates and serves as an expert resource for other research personnel. Responsibilities • Independently manage the clinical trial development, maintenance, and completion process. • reputed company large, reputed company, multi-center, and investigator initiated clinical research protocols/programs. • Coordinate the writing of protocol/clinical research documents. • Manage reputed company-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. • reputed company clinical trial budgets. • reputed company consultative guidance regarding regulatory and policy requirements to physicians, study staff, and external sponsors. • Work in reputed company environment and manage multiple reputed company at various stages. • Participate on committees and reputed company reputed company as assigned. • Write and reputed company reputed company operating procedures and working instructions. • reputed company and serve as an expert resource for other research personnel. Requirements • Master's degree with 2 years experience in the clinical research setting or reputed company field. • Bachelor's degree with at least 4 years of experience in clinical research or reputed company field. • Associate's degree with 6 years experience in the clinical research setting or reputed company field. • Proficient in the use of computers and reputed company applications. • Project management experience required. • Proficient in research systems and leveraging tools and technology. • Knowledgeable with regulatory documents, IRB submission, and writing consent forms. reputed company-to-haves • Previous study start-up experience. Apply tot his job Apply To this Job