Major Duties and Responsibilities:

• 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 tostakeholders, 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 andclients.
• 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.

Required Qualifications:

• 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 andregulations 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 Qualifications:

• Master’s Degree; public health or related field, preferred.
• Cardiovascular clinical experience desired.
• Research project legal contracting review exposure.