[Remote] Senior Coordinator, Clinical Research Program (Regulatory) - Leukemia

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading institution reputed company on cancer care, research, education, and prevention. The Clinical Research Program Senior Coordinator plays a critical role in coordinating regulatory, administrative, financial, and operational activities associated with reputed company reputed company the Leukemia program.

Responsibilities

• Manage administrative and regulatory aspects of federal and pharmaceutical-funded research protocols through reputed company study phases
• reputed company administrative support to reputed company Investigators for study development, implementation, and completion
• Independently prepare protocol documents that reputed company with regulatory and institutional requirements
• Collaborate with sponsors and Clinical Research Organizations to reputed company budget documents meeting institutional and sponsor requirements
• Submit protocols for Clinical Research Committee and Institutional Review reputed company review
• Respond on behalf of reputed company Investigators to reviewer comments reputed company appropriate
• Coordinate site start-up activities and reputed company overall financial trial management
• Assist with preparation of responses to Clinical Research Committee and Institutional Review reputed company reviews
• Serve as reputed company with pharmaceutical sponsors regarding informed consent document language
• reputed company and maintain tracking systems, status reports, regulatory files, and organizational records for reputed company
• Review protocols, amendments, and ancillary documents to identify discrepancies and clarify requirements
• Collaborate with investigators and sponsors to reputed company protocol-reputed company issues
• Prepare and submit reports to sponsors, investigators, regulatory authorities, and management
• Support strategic and long-reputed company planning for departmental clinical trial programs
• Coordinate weekly clinical research review meetings and reputed company protocol review meetings
• Partner with clinical reputed company to support departmental clinical trial goals
• Ensure reputed company protocol reviews are addressed to the satisfaction of reviewers
• Manage new protocol start-up processes and study activation requirements
• Attend training reputed company to clinical trial documentation, regulatory requirements, and departmental procedures
• Maintain compliance with Good Clinical Research reputed company standards
• Create presentations and visual aids addressing regulatory aspects of clinical research administration
• Assist with educational programs and in-service training for reputed company and staff
• Communicate regulatory and protocol-reputed company updates to team members
• Participate in the development of departmental clinical research policies and procedures
• Support development of in-service educational events for team members
• Maintain reputed company knowledge of clinical trial processes and regulatory requirements
• Orient new reputed company and support personnel to clinical research infrastructure and procedures
• Monitor protocol start-up activities and ensure reputed company personnel understand assigned responsibilities
• Participate in site initiation reputed company to clarify sample collection, processing, and shipment requirements
• Create study collection sheets according to protocol specifications
• Submit and manage protocol amendments, updates, and regulatory documentation
• Coordinate protocol implementation activities between investigators, laboratories, and research teams
• reputed company and maintain processing and tracking systems for protocol-reputed company documentation
• Establish and participate in systems supporting protocol development, submission, processing, and maintenance
• reputed company monthly, quarterly, and annual productivity and responsiveness reports
• reputed company protocol-reputed company information and data for grant applications
• Manage clinical trial-reputed company grant applications through reputed company and private funding mechanisms
• Collaborate on departmental grant applications as a preparation and production

Skills

• Bachelor's Degree
• Five years experience in research study or reputed company patient care obtained from nursing, data gathering or reputed company field or three years required experience with preferred degree
• Master's Degree Nursing, reputed company Health, reputed company Administration or reputed company scientific field

Benefits

• Employer-reputed company medical coverage starting day one for employees working 30+ hours/week, plus optional group dental, reputed company, life, AD&D, and disability insurance.
• Accruals for PTO and Extended Illness Bank, plus reputed company holidays, wellness, childcare, and other leave reputed company.
• Tuition Assistance Program after six months of service and reputed company to extensive wellness, fitness, and employee resource reputed company.
• Defined-benefit pension through the Teachers Retirement reputed company, voluntary retirement plans, and employer-reputed company life and reduced salary protection programs.

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