The Project Director II will perform a wide variety of duties to help the Principal Investigator coordinate all phases of clinical research, assist in the creation and management of appropriate infrastructure necessary to support clinical research programs and research activities. The Project Director II will work under the direction of and report to the Principal Investigator. 5-10 years experience necessary. Master’s degree preferred. The Project Director II is responsible for the direction of multiple projects within a research group.
The ProjectDirector II will perform a wide variety of duties to help Clinical Investigator coordinate all phases of clinical research, assist in the creation and management of appropriate infrastructure necessary to support multiple clinical research projects and research activities. The Project Director II will work under the direction and report to the Clinical Investigator.
The ideal candidate will have had formal training in Good Clinical Practice for Clinical Trials Research and prior experience in the direction of rigorous and complex funded clinical research projects, preferably clinical trials. Prior experience creating instruments for electronic data collection (EDC) and implementing and managing EDC management system is an asset. An understanding of clinical and research pertinent to older nursing home residents would also be considered an asset.
He/she is expected to work within the limits of standard research practice and follow established policies and procedures when executing the all responsibilities. These responsibilities will include the activities in the following areas:
• Organization of study start-up (implementing the standard operating procedure (SOP) manual activities at the HSL site, training in use of electronic data collection tools, broad study organization).
• Oversee execution of study protocol (data gathering, randomization, fidelity to intervention).
• Oversee data management (ensure electronic data capture aligns with manual of operations).
• Oversee recruitment efforts and target by working closely with the Research Associate responsible for recruitment.
• Coordinate and attend all regular study meetings, and prepare documents and report to the Institutional Review Board and Data Safety and Monitoring Board.
• When executing these responsibilities, he/she will ensure regulatory compliance including both governmental (NIA,FDA) and institutional (IRB), Office of Human Subjects Protection (OHRP) and adherence to HIPAA regulations. He/she will assure that informed consent is obtained, and when working with nursing home populations, or cognitively impaired populations, following established governmental guidelines for research with vulnerable populations.
• He/she will review, evaluate and make verbal or written reports as directed by his/her supervisor and perform special projects or other related duties as responsibilities necessitate.
• As a member of HSL IFAR, he/she will agree to occasionally serve as a consultant to IFAR principal investigators and provide functional leadership to institute research coordinators to facilitate/plan successful studies.
• He/she may be required to present to professional and lay community through co-authored publications and oral presentations as necessary.
• The above covers the most significant responsibilities of the position. It does not, however, exclude other duties, which would be in conformity with the level of the position. Completes special projects as assigned.
• 5-10 years experience necessary
• Expert interpersonal skills are required to guide and encourage complete participation in study protocols and to forge and maintain productive working relationships with participants, families, research team members, internal and external collaborators and vendors, and others.
• Have excellent computer skills including ability to communicate with email, use MSWord, MSExcel, MS Powerpoint, Pub Med searches, and internet applications for online meetings. Must have solid foundation or aptitude to learn electronic data capture systems.
• Working knowledge of the regulations governing the conduct of human studies research.
• Must be professional, proactive, collaborative, conscientious and results-oriented individual. Must have an optimistic and positive demeanor, excellent oral and written communication skills, good intuition and able to adapt to changing priorities and display good, sound judgment with a sense of humor.
• Superb organizational skills. Must have solid analytical skills. Must be creative and proactive yet disciplined, discriminating and able to streamline work volume in order to maintain bottom line efforts in midst of multi-tasking and daily re-prioritizing. Must have ability to innovate, think strategically and conceptually, manage multiple projects simultaneously and handle even difficult situations.
• Must be motivated to learn and flexible to change.