INC Research - Kiev (Ukraine)
Job Description
Job SummaryINC will be recruiting for an In House CRA with Ukranian language skills. Please apply now so we can consider your application when the position becomes live.Responsible for remote monitoring and site management of Phase II-IV clinical research studies while continuing to develop a solid understanding of the drug development process, Good Clinical Practices (GCP), and relevant regulations. Manages and oversees study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines, Standard Operating Procedures (SOPs) and Project Specific Operating Procedures.
Core Responsibilities
1.Site Management
•Serves as the primary contact and company representative for sites on assigned studies.
•Manages assigned sites via outbound telephone calls, web-based tools and other communications tools to ensure compliance with the protocol requirements, study procedures and relevant guidelines.
•Creates contact reports for each telephone session (outbound or inbound) with sites.
•Monitors site performance metrics and, with guidance, implements action plans for sites not meeting expectations.
•Supports patient enrollment at each assigned site via engagement of sites in study-wide patient recruitment programs, or through development of site-specific enrolment plans.
•Maintains up-to-date information within the deployed Clinical Trial Management System (CTMS).
•Ensures all assigned sites are trained on the study protocol, informed consent process, data collection requirements/data collection tools (e.g., Electronic Data Collection (EDC) systems, Interactive Voice/Web Response (IVR/IWR) systems, etc.), Serious Adverse Event (SAE) reporting requirements and patient-reported outcomes instruments, as applicable.
2.Communication
Maintains timely and effective communication among team members and site staff, through oral/written correspondence and ensures adequate documentation of each communication. Routinely anticipates/indentifies and resolves potential issues.
3.Regulatory Documentation
Assures compliance with applicable regulations, and guidelines, Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) and GCP guidelines, and Company and Sponsor SOPs. Maintains current regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File (TMF) Plan. Participates in TMF and audits as requested; may require guidance to respond to findings.
4.Monitoring
Monitors all types of Phase II-IV clinical trials; participates in all types of remote site visits as required.
5.Data Handling
•Assures timely completion and submission of Electronic Case Reports Forms (eCRFs) in accordance with study-specific clinical and data management plans.
•Reviews eCRFs completed by sites and assists the site in resolving queries and/or other identified data collection issues.
•Assures timely and accurate completion of Data Clarification Forms.
•Performs review of clinical data listings, as required.
6.Reporting and Tracking
•Completes and submits visit reports according to SOP/Works Instructions (WI) or Sponsor requirements.
•Maintains awareness of key study performance indicators for own sites, e.g. Telephone Communications Reports, patient enrolment, and SAEs/Endpoints.
•Updates study and patient status information. Documents and tracks the resolution of all outstanding site-specific protocol-related issues from contact to contact.
7.Administrative
Prepares for and attends Investigator meetings; may present materials, as requested. Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project communication, monitoring, and/or training plans.
OTHER RESPONSIBILITIES:
Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).
Skills & Attributes
- Language skills: English and Ukranian
BA/BS degree in science/health care field or nursing degree, or equivalent combined education and experience, required. Nominal clinical research experience required including independent monitoring and site management experience preferred, whether remote or on-site. Moderate understanding of clinical research fundamentals expected. Basic understanding of SOPs, WIs, FDA, and local regulations as well as ICH GCP guidelines, required. Strong organizational, documentation, and interpersonal skills essential as well as a willingness to work within a team-oriented environment. Excellent command of written and spoken local language, if not English, as well as English required. Ability to develop excellent working relationships via oral communication and excellent phone etiquette, required. Must be proficient in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail. Ability to handle multiple tasks to meet deadlines in a dynamic environment, required.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract.
Occasionally required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
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