"A general overall assessment of the quality and completeness of the data available for conducting the safety review should be provided, with a description of the basis for this assessment. Attention to completeness and quality of assessment is important throughout the review, recognizing that quality for the primary source data may differ from quality for data over which the applicant had less control." (FDA, MANUAL OF POLICIES AND PROCEDURES CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 6010.3, Clinical Review Template, item #7.2.8 Assessment of Quality and Completeness of Data.) Principal Investigator (PI) is legally responsible for ALL aspects of the research study. PI is responsible for assuring adherence to governmental regulations and guidelines, SOPs in preparation, conduct and reporting of clinical trials. PI is also responsible for interpreting such guidelines to direct reports (e.g., investigators, study coordinators, etc.) PROTECTING THE RIGHTS AND WELFARE OF HUMAN SUBJECTS EVALUATING NEW PROTOCOLS FOR FEASLIBILITY PREPARING THE SITE FOR STUDY CONDUCT PARTICIPATING IN THE INFORMED CONSENT PROCESS MANAGING STUDY CONDUCT read more >> [#] Principal Investigator (PI) is legally responsible for ALL aspects of the research study. PI is responsible for assuring adherence to governmental regulations and guidelines, SOPs in preparation, conduct and reporting of clinical trials. PI is also responsible for interpreting such guidelines to direct reports (e.g., investigators, study coordinators, etc.) PROTECTING THE RIGHTS AND WELFARE OF HUMAN SUBJECTS (these responsibilities always apply regardless of research site or research setting): Understanding the regulatory, institutional, sponsor and protocol requirements for the study. Completing any sponsor-required human subjects protection training. Capturing and reporting adverse events to the sponsor. Ensuring that protected health information will not be reused or disclosed to any parties other than those described in the protocol, except as required by law. EVALUATING NEW PROTOCOLS FOR FEASLIBILITY. This may include: Reviewing the protocol and other materials (e.g., Investigator’s Brochure, data collection forms and sample consent forms) for practical procedures, safety issues and establishment of a study budget. Reviewing study participant eligibility requirements and determining if those participants would be available in sufficient numbers to achieve study enrollment goals. Assessing the logistical requirements and resources necessary to conduct the study. PREPARING THE SITE FOR STUDY CONDUCT. This may include: Preparing document for submission to the IRB. Setting up and organizing study files. Training all people involved in the study conduct (e.g., faculty, study staff, ancillary personnel, etc.) Collaborating with laboratory, pharmacy, etc. as needed. Attending the investigator kick-off meeting. Scheduling and facilitating a site-initiation visit with the study sponsor. Creating or reviewing study-specific source documents. Collecting the documents needed to initiate the study and sending them to the study sponsor. PARTICIPATING IN THE INFORMED CONSENT PROCESS. This may include: Writing study consent forms according to regulation and guidelines. Working with the sponsor on informed consent form wording issues. Translating consent forms into Ukrainian and/or Russian languages when necessary. Conducting the informed consent process with potential participant (or authorized legal representative) Discussing all aspects of study participation; Reviewing the consent form with the potential study participant; Answering questions and assessing potential study participant’s comprehension; Ensuring that all necessary signatures and dates are on the informed consent forms; Documenting, distributing and filing signed informed consent forms appropriately; that all amended consent forms are appropriately implemented and signed; Ensuring that the consent process is ongoing and continues throughout the duration of the study. MANAGING STUDY CONDUCT This may include: Recruiting and screening potential participants. Ensuring adherence to the study inclusion/exclusion criteria. Scheduling and managing study participant study visits (e.g., ensuring that all appropriate study procedures are done and documented). Managing laboratory procedures (drawing samples, processing, packaging and shipping). Reviewing care report form entries for completeness and correctness. Reviewing care report forms and source documents for adverse events (AEs). An investigator is responsible for knowing the policies of the local IRB, adhering to these policies, and maintaining a copy of the policies in the study file. An investigator is also responsible for the accurate documentation, investigation and follow-up of all possible study-related adverse events. Scheduling and facilitating sponsor monitoring visits. Ensuring that test article accountability is done correctly for each study participant and overall. Minimum Qualification Requirements: Ability To: Communicate effectively with the Sponsor or designee, clinical study staff; render decisions and policy interpretations; and provide guidance and leadership in the performance of complex planning, coordination and evaluation of duties for a clinical trial project. Ability to independently identify and effectively offer solutions to problems. Exhibit excellent technical skills including the ability to comprehend, integrate and interpret scientific and medical data from a variety of sources. Knowledge Of: Working knowledge of pharmacovigilance; clinical safety regulations and guidelines; and clinical research trials methodology, design, implementation, and analysis. Must have demonstrable knowledge of FDA regulations, ICH GCP guidelines, Industry Standards of Clinical Research, and clinical trials research and management. Working knowledge of epidemiology Education: Possession of a Doctoral degree (e.g. M.D., Pharm.D., PhD) from an accredited college or university in a field related to biomedical research or life science. Experience: In addition to education requirements, a minimum of three (3) years relevant experience in drug safety within the pharmaceutical industry, academic facility or clinical research. 3 years clinical practice experience Preferred Background: Experience with conducting clinical trials for submission for US FDA and European Regulatory Authorities Skills: Comfortable working on teams. Good leadership, written and verbal and communication skills hide << If you are a physician interested in participating in present and future clinical trials (Если Вы - врач, заинтересованный участием в настоящих и будущих клинических испытаниях) Please, click here For any questions mail to: info@ee-sct.com