Project Director, Research
Lowell General Hospital
Boston , MA 02298
Posted 2 months ago
The Clinical Trials Project Director will report to and work closely with the Principal Investigator in the coordination and management of the clinical trial operations for the Bayer Niclosamide for COVID-19 Clinical Trial.
In general this individual will possess varying components of expertise and knowledge in the following areas:
project management, data monitoring, biostatistics and safety surveillance, human investigation requirements, clinical care, disease processes and practical clinical trial applications.# This person will provide general operational assistance, oversee the work of the research study coordinators and ensure a seamless level of communication between program staff and participating sites.# # In this role the Project Director will provide leadership and guidance while overseeing enrollment.# The Project Director will also play a primary role in the Coordinating Center#s activities where he/she will be directly involved with the implementation of systems and processes including, various manuals and web-based systems.# He/she will be expected to apply extensive expertise and in-depth knowledge of clinical trials research and will be expected to contribute to the content, systems and documentation.# The Project Director will work with the research administration team to review resources and ensure compliance on multiple levels as related to the scientific goals and trial#s outcomes. Responsibilities:
Assist the Principal Investigator in the establishment and ongoing communication and operational flow of the research activities between the Coordinating Center, enrolling sites, Data Coordinating Center (DCC), and Core Laboratories.
Oversee implementation of training procedures that will be used to ensure equal standards of learning for study staff at each site.# This person will assist the team to conduct on-line training components in conjunction with the content and procedural investigator experts from the trial.# Will monitor and maintain status report results from the staff training and tracking system. #Assist in conducting in person group training sessions associated with all aspects of the trial including patient enrollment, testing, study drug infusion, data collection and follow-up.# These in person sessions complement and integrate the study drug, tracking and ordering systems demonstrations of procedures and related procedures and documentation during the study drug infusion. Fully comprehend and manage all aspects related to the study drug, patient laboratory testing supplies and samples, and monitoring equipment. This will include purchasing, storage capabilities, distribution, and tracking procedures for the drug, as well as at-home swab tests and courier services to bring to labs.
####Oversee procedures and associated study drug documents in conjunction with the manual of operations
Contribute to the oversight and development of associated regulatory issues in US
. Monitor the site#s adherence to the study protocol#s human investigation requirements to ensure that all investigators, paramedics and research assistants complete the on-line NIH educational program for the protection of human research participants and any additional HIPAA requirements.# #Review and summarize the reports from the DCC on study subject screening and enrollment.
Work with the budgetary staff by providing approval of enrollment statistics to ensure proper support and payment to those who assisted in the enrollment processes
. Apply extensive expertise and in-depth knowledge of clinical research to recommend appropriate course of action regarding questions posed by the study staff.# Will participate as a member of the rotating, on-call clinical support team providing 24 hour, 7 day a week coverage to answer clinical or operational questions. Will possess a thorough understanding of data management and related processes in order to represent the Coordinating Center.# Provide expertise during the training and monitoring of data collection, checking, tracking systems, and the reporting mechanisms throughout the study.
Supervise and manage the junior staff in their day-to-day functions at the Coordinating Center and the sites.# She/he will monitor the output of research staff and pay close attention to overall adherence to the timeline and milestones in order to meet the research objectives. Will participate and lead site meetings and conference calls.# Will travel to sites for start-up, training and additional meetings or site visits as needed. Requirements:
Requires a clinical degree (RN, BSN, MSN, PharmD) and a PhD in a research and/or health sciences related field.
Minimally five to seven years of management experience in research or clinical trial environment; in addition to clinical experience.# Ability to provide leadership in the preparation of clinical trial development plans and project research strategy. Excellent judgment, poise, and tact, strong interpersonal skills, ability to handle a large number of competing demands simultaneously, attention to detail, and the ability to interact with a wide variety of personnel, departments, and organizations. Candidate needs to have superior communication skills (both written and oral), organizational skills, project planning and management skills with a drive to meet deadlines.# Candidate must be innovative, proactive, and motivated, with a focus on continuous improvement and a strong desire to succeed.
Ability to take initiative and in turn function at a high level of independence as demonstrated by independent decision-making, ability to solve problems, know when to ask for guidance, and the ability to represent the Project Director. Proficiency with Microsoft Office software, including Excel, Access, and Word.