General Responsibilities

• Oversees day-to-day activities of the projects.
• Manages project staff's interaction with participants and data collection; assesses and ensures that staff follow protocols and standard operating procedures.
• Manages the recruitment of study participants according to approved methodologies; ensures that study staff correctly assess eligibility and carry out the informed consent process with participants.
• Measures projects' progression toward successful completion of project goals; plans and ensures all corrective action and implementation.
• Maintains fiscal oversight; prepares budget modification requests to sponsor as needed; reconciles study budget accounts with business manager.
• Oversees proper project closure including finalizing all qualitative and quantitative data and handing off any project deliverables such as study created decision aids, educational materials, and result summaries to the sponsor, stakeholders, and external partners.
• Coordinates the design and development of all databases that will ensure the accurate tracking of all individuals approached for studies and the safety and security of all data.
• Determines the activities, sequence and time allotted for each activity, and the resources required to achieve the projects' goals.
• Develops project plans including risk management plans; continuously assesses and updates the plans throughout the projects' life cycle.
• Works with project teams to develop all required material including but not limited to advertising, recruitment brochures and letters, surveys, and educational materials for research participants and stakeholders.
• Coordinates activities of the project team including staff, operations support, consultants, vendors, patient, and community advisory boards, and co-investigators; fosters accountability and ensures that all project team members feel supported in their roles.
• Develops schedules for project staff.
• Assists in developing, writing, and submitting research proposals. Coordinates meetings and compiles proposal documents. Writes sections of the proposal especially the methods and human subjects' sections. Prepares the proposal budget and justification in conjunction with other stakeholders.
• Responsible for accurate preparation and timely submission of all regulatory documents.
• Maintains current knowledge of regulatory affairs and/or issues; maintains a high level of expertise through familiarity of clinical literature and attending continuing education classes.

General Responsibilities

• Oversees day-to-day activities of the projects.
• Manages project staff's interaction with participants and data collection; assesses and ensures that staff follow protocols and standard operating procedures.
• Manages the recruitment of study participants according to approved methodologies; ensures that study staff correctly assess eligibility and carry out the informed consent process with participants.
• Measures projects' progression toward successful completion of project goals; plans and ensures all corrective action and implementation.
• Maintains fiscal oversight; prepares budget modification requests to sponsor as needed; reconciles study budget accounts with business manager.
• Oversees proper project closure including finalizing all qualitative and quantitative data and handing off any project deliverables such as study created decision aids, educational materials, and result summaries to the sponsor, stakeholders, and external partners.
• Coordinates the design and development of all databases that will ensure the accurate tracking of all individuals approached for studies and the safety and security of all data.
• Determines the activities, sequence and time allotted for each activity, and the resources required to achieve the projects' goals.
• Develops project plans including risk management plans; continuously assesses and updates the plans throughout the projects' life cycle.
• Works with project teams to develop all required material including but not limited to advertising, recruitment brochures and letters, surveys, and educational materials for research participants and stakeholders.
• Coordinates activities of the project team including staff, operations support, consultants, vendors, patient, and community advisory boards, and co-investigators; fosters accountability and ensures that all project team members feel supported in their roles.
• Develops schedules for project staff.
• Assists in developing, writing, and submitting research proposals. Coordinates meetings and compiles proposal documents. Writes sections of the proposal especially the methods and human subjects' sections. Prepares the proposal budget and justification in conjunction with other stakeholders.
• Responsible for accurate preparation and timely submission of all regulatory documents.
• Maintains current knowledge of regulatory affairs and/or issues; maintains a high level of expertise through familiarity of clinical literature and attending continuing education classes.