The project manager will work closely with the Principal Investigators, senior project manager, and independently to plan and implement all phases of a large (9,000 subjects) multi-site POCRI funded clinical trial conducted in the United States. Responsibilities include assisting in site start-up; IRB preparation of protocols, amendments and continuing reviews as well as maintaining compliance with IRB requirements using both local and central IRBs. In addition, the candidate will work closely the training and supervision of the research assistants who are the primary contacts for the sites and ensures proper handling of site issues and questions. The candidate must have the ability to work independently, as well as working with other research staff, both professional and non-professional, excellent written and oral communication skills, attention to detail, and ability to prioritize a variety of tasks. The project manager will be responsible for the development, refinement, and implementation of study procedures and preparation of data. Works with Principal Investigators and Senior Project Manager to design, supervise, and implement numerous complex and interrelated procedures involved in recruitment, data collection, processing, analysis, and presentation of data for the PRECIDENTD trial. Assists with preparation of and updates to the PRECIDENTD Manual of Operations to document study procedures and insure that activities are consistent with study protocol.Prepares submissions to the IRB and maintains in-house regulatory file for the PRECIDENTD trial.Helps to hire, train, and supervise Research Assistants and other study staff. Directs daily activities and provides guidance in the execution of specific areas of their responsibility.Responds to questions from staff regarding any issues that may arise; decisions are based on a thorough knowledge and expertise of PRECIDENTD objectives and methodology. Coordinates the development of PRECIDENTD newsletters, and assists in the development of other PRECIDENTD study materials, documentation, and content.Oversees incoming data collection and coordinates overall data flow. Coordinates reporting of data with PRECIDENTD programmers. As needed, develops review manuals and data dictionaries for PRECIDENTD follow-up data.Interacts with study site teams to ensure protocol implementation and troubleshoot site issues. Performs all other duties and assignments as requested.Qualifications Qualifications:Minimum requirements are a B.A. or B.S. degree. Masters preferred, and a minimum of five years of experience in a research environment. Prior supervisory experience required.
Skills / Abilities:Requires the educational background, level of maturity, and responsibility to work independently and under pressure and still meet the requirements of scientific validity posed by a clinical trial. Sound independent judgment and competence in research methodologies in order to articulate the objectives of a complex clinical trial. Excellent reading, writing, and interpersonal skills to deal effectively and professionally over the phone with study investigators, outside collaborators, and participants. Problem-solving skills to track participants and to develop a unique follow-up strategy for difficult cases.Organizational skills with an emphasis on time management in order to perform a high volume of work under the pressure.Knowledge of medical terminology as well as familiarity with the ICD-9 and -10 coding systems.Knowledge of HIPAA regulations and the ability to demonstrate professionalism and respect for subjects rights and individual needs.EEO Statement
BWH is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.