Clinical Project Lead

Washington, DC
United States

MedStar Health Research Institute

201 to 500 employees

Company Info

Job description

The Clinical Project Lead will effectively lead the project team, ensuring on-time, within budget, quality performance, and delivery of projects.

Principal Duties and Responsibilities:

  • Assist either the Clinical Project Lead, Data Management/ Regulatory with their assigned tasks.

  • Assist the Clinical Project Lead, Data Management with the oversight of the Research Data Coordinator with Data Management tasks.

  • Plan, organize and manage all aspects of the assigned clinical trial;

  • Collaborate with Contracts and Regulatory team in site budget contracting;

  • 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 on a day to day basis, ensuring subject recruitment milestones are met;

  • Collaboration with Data Coordinating Center in Case Report Form design;

  • Collaborate with Data Center in programming; preparation of queries and final reports. Communicate with internal departments and external organizations regarding database design and implementation.

  • 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.

Minimum Qualifications:

Education:       Bachelors' in Health Care Field or Life Sciences required,  Masters' Degree in Health Care Field or Life Sciences preferred.

Experience:     One 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.

Work location: Washington, DC

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