Evolution Research Group · 2 months ago
Principal Investigator Clinical Trials (FT PI)
New York, NY, US
Full-time
Onsite
Lead/StaffEvolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. They are seeking a Principal Investigator to ensure adherence to protocol requirements and protect the rights and welfare of study subjects while assuring the integrity of data generated at the site.
AssociationBiotechnologyGovernmentHealth CareLife Science
Responsibilities
Work with the Site Director and Medical Director to provide oversight of Sub-Investigator. Review work to ensure adherence to SOPs, ICH GCP guidelines, and protocol requirements
Work with Site Director, Study Coordinator, and Recruitment Manager to develop effective programs for study enrollment
Work with Site Director to ensure that all staff are adequately trained and adhere to Standard Operating Procedure and working guidelines while performing study procedures on assigned studies
Work with the Site Director to ensure the site has an adequate number of qualified staff, adequate facilities, and that the PI has adequate time to conduct the study
Maintain a current, up to date curriculum vitae
Maintain current licensure to practice
Oversee all trial-related medical decisions or ensure that a qualified sub-investigator is available to do so
Assess subject compliance with the test article and follow-up visits
Assess subject's response to therapy
Evaluate for adverse experiences per protocol guidelines
Assist with rating scales
Provide new information about the study or test article(s)
Document deviations from the approved protocol
Document and explain premature unblinding of the investigational product(s)
Thoroughly familiar with the use of the investigational product(s)
Communicate effectively with subjects, research team, IRB, and sponsor
Qualification
Required
M.D, D.O., or PhD required
Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner
Knowledgeable in medical terminology to communicate with physician office and laboratory staff
Skilled in working with potential sponsors to place research with the site
Work effectively with a staff of clinical professionals and creates a productive, satisfying work environment
Demonstrate the ability to initiate activity as required and making appropriate decisions within the constraints of study protocols and, regulatory requirements
Able to initiate or modify behavior to achieve desired outcomes despite environmental factors, priorities, or problems that might not be well defined or that are subject to change
Experienced negotiation skills
Formal presentation skills
Ability to perform overnight business travel
Excellent persuasive/selling skills
Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines
Knowledgeable in medical terminology
Excellent communication skills (interpersonal, written, verbal)
Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)
Benefits
Medical and dental coverage
A matching 401(k)
Paid time off to recharge
Company
Evolution Research Group
Evolution Research Group is an independent clinical research site company in the U.S.
Founded in 1998
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Rob Chestnut, CMA
Chief Financial Officer
Andria Chastain
Chief Operating Officer
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