Associate, NCDR Research Studies

The Research Study Manager will serve as the project manager and primary point of contact for a portfolio of registry-based research studies for the National Cardiovascular Data Registry (NCDR). This individual will support the complete lifecycle of research studies by assisting in the development of study protocols, drafting contractual agreements, and ensuring the timely completion of study milestones by collaborating with a cross functional team to ensure high quality client deliverables. This role requires an individual with strong attention to detail, broad cardiovascular clinical knowledge and analytic skills with an engaging, collaborative, and client-focused approach to working with a multitude of internal and external stakeholders. Serve as study manager for FDA, NIH and industry-sponsored and investigator-initiated research studies by implementing reliable methods to support clinical research activities. Contribute scientific, clinical, data, and technical expertise to guide the execution of complex research projects. This includes, but is not limited to: Leading research focus interactions with clients in the medical device and pharmaceutical industries and provide clinical registry expertise and guidance to support custom data analytics and research study requests. Reviewing inbound research questions, requests, and study protocols to determine the feasibility of conducting studies within the context of the NCDR infrastructure. Working closely with physician members, and member committees to facilitate clinical, scientific, and strategic review of new research proposals. Work closely with the data analytics team and data analytics centers to review and assess the suitability of research proposals Work closely with the data analytics team and data analytics centers to facilitate the completion of accepted projects. Drafting study procurement documents that accurately capture the scope of work to be performed and translate client requests into statements of work, project budgets, and project contracts. Coordinating the activities of internal and external cross-functional teams and monitor the progress of study milestones and deliverables, ensuring quality and timeliness of project deliverables. Preparing and submitting IRB applications. Ensuring alignment of budgets with study needs and responsible for invoicing and tracking revenue and expenses for the life of the study. Preparing and submit project status and effort reporting to stakeholders, including federal agencies, industry, committees, and internal staff. Represent ACC on internal and external groups, as assigned. Build and maintain excellent relationships with internal and external partners and clients. Anticipate risk and identify challenges early on and communicate project risk as well as possible risk solutions to Team Lead. Work with internal IT teams, NCDR registry product managers and others as appropriate to ensure the logic and application of registry data for various study types. Serve as a liaison between ACC registry management teams and external research partners 4+ years of related work experience. Bachelor’s degree; in public health or related field, preferred. Strong organizational, critical thinking, and problem-solving skills with the ability to manage and track multiple tasks simultaneously and autonomously and set priorities under strict deadlines. Knowledgeable of Good Clinical Practice guidelines and regulations governing research, data, and health information privacy, and data security. Proficient understanding of medical terminology specific to cardiology. Knowledge of applicable cardiovascular clinical procedures and techniques. Excellent analytic and problem-solving skills. Demonstrated excellent oral and written communication skills. Familiarity with Windows-based office productivity software products, especially those currently in use at the American College of Cardiology (WORD, EXCEL, ACESS, PowerPoint, Monday.com, JIRA, Novatis, Confluence). Self-directed ability to initiate and follow through on projects and tasks. Ability to work across teams, departments and functions, providing project guidance and direction to colleagues and peers. Ability to travel to support College and committee meetings as needed. Desired: Master’s Degree; public health or related field, preferred. Cardiovascular Clinical experience desired. Research project legal contracting exposure and knowledge.