Nature and Scope of Position:
The Clinical Project Lead will effectively lead the project team, ensuring on-time, within budget, quality performance, and delivery of projects.
Supervise the daily activities of the Angiographic, VH and OCT Core Lab, specifically oversee the data collection and analysis of research studies in the Angiographic Core Lab. Actively promote the Angiographic Core Lab and seek new business. Additionally work with the respective managers and coordinators within the CRI Core Labs to promote systemness.
Principal Duties and Responsibilities:
· Supervise all administrative functions of Angiographic, VH and OCT Core Lab including coordination of day to day activities.
· Oversee all of the research data generated from the Angiographic, VH and OCT Core Lab. This oversight includes case report form design for the core lab studies, procedures for quality control, reporting, data resolution, record retention and archiving data. And when needed, procedure final reports for sponsors.
- Work with the Director of CRI CRO to create new business by actively promoting the services of the Angiographic Core Lab, initiating collaborations with sponsors, including protocol development and contract negotiation, and initiating and contributing to collaborations with other institutions.
· Lead and manage the efforts of all key functional departments to perform all project-related activities according to project milestones;
· Prepare monthly status reports for monthly project review meetings;
· Liaise with sites as needed to ensure timely and accurate submission of films to the Core Labs for review;
· Collaboration with Center for CRI Databases and Programming Technologies in case Report Form design;
· Collaborate with the Center for CRI Databases and Programming Technologies in preparation of building, deployment, queries and final report generation.
· Communicate with internal departments and external organizations regarding database design and implementation.
· Coordinate and manage logistics of the Director, Experimental Angioplasty, Emerging Technologies, and Clinical Research Operations or designee (Clinical Research Scientist) assigned to overread all Core Lab analyses as needed
· Acquire and develop a working knowledge of the data to day activities of the Core Labs.
· Oversight of the following task completions: logging incoming CD and Core Lab case report forms, Core Lab data clarification forms, edit checks design and execution, Core Lab queries and study related report requests, Core Lab resolution of data entry discrepancies, Core Lab entry data clarification responses, and investigating data anomalies.
- Associate consistently demonstrates support for compliance in the performance of job duties and responsibilities by a) developing and maintaining knowledge of, and performing job functions in compliance with, rules, regulations, policies, and statutes that affect his/her job; b) maintaining knowledge of and performing job functions in compliance with MedStar Health and MedStar Health Research Institute policies and procedures; and c) reporting compliance concerns in an appropriate and timely manner.
· Other duties as assigned.
Education: Master’s Degree in Health Care Field or Life Sciences preferred. Prior Cardiology/ Interventional Cardiology Research Experience preferred.
Experience: Two to three years experience in Phase I-IV clinical trials and knowledge of medical field. Excellent working knowledge of FDA, ICH, GCP and other regulatory functions. Proficiency with basic computer programs and exposure to relational databases. Must possess excellent writing skills and ability to communicate effectively with staff and management.