Overview
The clinical trial project director will plan, organize, lead, and perform comprehensive and advanced level clinical research duties for a complex clinical trial involving 12 hospitals and collaborators across several universities. The successful candidate will directly impact the overall efficiency, productivity and success of the trial. The clinical trial project director must be able to work independently and has the authority to interact with internal or external stakeholders involved in a clinical trial or modify clinical trial workflow or processes to meet the needs of the study.
Duties include:
Manage multiple Principal Investigator relationships with internal and external research stakeholders.
Provide guidance and assistance to Principal Investigators for budget management and research compliance oversight to ensure full compliance with local/institutional, state and federal policies and procedures.
Assist Principal Investigator in developing clinical trial protocols and submit the required documentation to the Institutional Review Board, the University, federal regulators in industry or government sponsor.
Coordinate and manage all aspects of clinical trial conduct for one or more trials.
Prepare and submit all types of clinical research documentation to the IRB of record (central or local) for review and approval.
Participate in planning and analysis of research portfolios, in conjunction with Principal Investigators.
Oversee the financial management, including budget development and quarterly review of project accounts.
Manage a team of research support staff, with responsibilities that include scheduling, workload management, professional development, and performance management.
Coordinate research education, training and/or orientation for new project members.
Compile data and documents during internal and external audits and for annual reporting to NIH.
Conduct research data analysis and literature searches. Co-author scientific papers, publications or presentations
In addition to the above job responsibilities, other duties may be assigned.
Minimum Requirements
Education: Master’s or other advanced degree required. DrPH or PhD preferred.
Experience: At least seven years of clinical research experience demonstrating progressive levels of responsibility and complexity of work. A terminal degree may substitute for the equivalent number of years of experience.
Licensure: None.
Travel: This is primarily a sedentary job involving extensive use of desktop computers. The job does occasionally require traveling within the US to attend meetings and visit study sites.
