Role Description The Sr Clinical Research Associate (Sr CRA) ensures the effective management and monitoring of clinical studies in the site(s) assigned by the Clinical Operations Project Manager (COPM), while respecting the protocol and in accordance with the standards of local regulatory authorities, the rules of Good Clinical Practice (ICH / GCP) and Servier Standard Operating Procedures (SOPs). This position could act as the leading CRA for the CRA team, and will assist COPM in all projects set up and management aspects and require a proven record of hands-on experience in processes such as: - Study feasibility and site qualification - TMF and ISF set up - Creation of monitoring plans - Preparation of IRB submission packages Qualifications - Bachelor’s degree or equivalent education/experience preferred in Scientific/health care field - 5+ years of Clinical Operations experience (including Clinical Research Associate roles) within a pharmaceutical company or CRO - Knowledgeable of current FDA and IRBs regulatory requirements and guidelines governing clinical research - Ability to oversee, manage and communicate effectively with clinical sites - Strong attention to detail, establish priorities and meet deadlines - Ability to work independently and take initiative - Strong knowledge of applicable computer software applications - Strong interpersonal skill set necessary to create and maintain internal and external collaborator relationships Requirements - Implement and monitor site(s) in assigned study(ies) - Contribute to the site’s identification and selection process, conduct the site’s selection and qualification visits under the supervision of COPM - Take an active role in the creation of the study monitoring plan, reference documents for sites; review other study related manuals and supportive documents if needed - Ensure the preparation of the site before the initiation visit and carry out the initiation visit and related follow up actions including initiation visit report and follow-up letter - Participate in the development of the sites recruitment plan and closely monitor the progress of recruitment of site(s) - Assist in the creation of the Investigator Site File (ISF) - When applicable, lead the CRA team of a specific study to organize and carry out trainings to all site’s research teams on the study protocol and related tasks - Perform monitoring activities according to the study specific protocol and monitoring plan - At study level, monitor the progress of clinical trials and ensure the quality, reliability and authenticity of data collected according to protocol, Servier SOPs, regulatory requirements and GCPs of all sites with the supervision of COPM - Check the validity and consistency of the data collected in the e-CRF; manage correction requests if necessary and supervise corrections - Identify and manage deviations with the personnel concerned at the site(s) - Ensure the detection and careful monitoring of adverse events (AE) and serious adverse events (SAE) representing pharmacovigilance cases and ensure the transmission of information to the departments concerned - Manage the logistics of the investigative site(s) including investigational products, clinical materials and biological samples - Serve as technical support to the investigators and be the first point of contact with the site’s staff regarding the monitoring and resolution of problems encountered - Report all monitoring activities (update data in the various clinical data management systems), write visit reports and follow-up letters to investigators - Perform site(s) closure visit - Other duties as part of the Clinical Operations team and leading CRA for a team - Assist the COPM in organizing investigators meetings - Train newcomers in the team including CRA(s), VIE, CTA - Assist in the preparation of ISF binders - Actively involved with regulatory submission including the site’s ICF review and validation, under COPM’s supervision - Assist COPM for budget and contract negotiation - Participate to UAT for the systems used for assigned study(ies) - Participate in Data Review along with COPM for the assigned study(ies) - Collaborate actively with the other members of the project team (Medical Monitor, Clinical Medical Scientist, other CRAs, CTA, Data Management, PV, CLL, CSU and etc) when needed - Involve in the preparation of study(ies) audits / inspections, assist other CRA(s) in the preparation of site(s) audits/inspections - Respond to observations from audits/inspections and ensure the implementation of the corrective and preventive actions - At Hub level, actively involved in processes improvement and tools development - Function as SME for CRA or CRA referent for the Americas Hub Benefits - Salary range: $131,000-$150,000 - Short-Term and Long-Term incentive programs - Medical, dental, vision coverage - Flexible time off (unlimited sick time and flex time) - 401(k) plan - Life and disability insurance - Recognition programs

Role Description Dow Jones Energy provides price transparency across the global fuel supply chain, including the Spot, Wholesale Rack, and Retail markets. Dow Jones Energy enables customers to buy and sell energy commodities with confidence with multi-platform access to accurate data, real-time news, powerful software, and educational events. Our commitment to reliability is reinforced by personalized customer service and constant innovation. - Identify sales leads via direct and indirect client contact. - Cover chemical markets and provide market updates for weekly and monthly reports. - Supply/Demand - Maintain, update, and balance long forms up through entire product chains, short forms, and quarterlies as needed. - Perform presentations for clients both in our offices and onsite. - Maintain a detailed working knowledge of the basic databases and tools for responsible products (Supply/Demand, Global Pricing System, Capacity Data Base, and Trade Grids). - Econometrics - Maintenance and modifications for product-specific models. - Assets - Maintain product capacities based on market intelligence. - Actively pursue and develop unique analytical approaches that provide value to clients and/or potential clients. - Maintain and develop knowledge of state-of-the-art industry processes for specific product chain. - Involvement with long-term projects related to responsible products such as cost studies, etc. Qualifications - Bachelor's Degree or equivalent experience - Chemical Engineering, Chemistry, or Technical Preferred. - Minimum of 5 years of experience. - Previous work experience in a Petrochemicals company is a significant advantage. - Previous experience using analytical skills, ideally as a Business Analyst. - Experience in customer-facing roles is an advantage. - Chemical industry knowledge combined with a good level of product expertise. - Expertise with Microsoft Office products. - A conceptual understanding of how economics and politics influence regional and global markets. - Proficient public speaker. - Ability to think through questions and/or problems and independently provide solutions. - Proactive and self-motivated, focused on delivery of quality results. - Good team worker. Requirements - Write and proof text for weekly and monthly reports. - Ensure charts and price files are up to date for routine reports. - Update Price/Supply/Demand/Forecast sections for reports. - Update/create meaningful charts for reports. - Answer client questions about data and services. - Discover prices through industry contacts; maintain price forecasts both short and long term. - Update Supply Demand Quarterly balances and Trade reports. - Contribute to Long Forms, Supply Demand, Trade, and Quarterly balances to ensure they are completed, accurate, and up to date. - Keep consultants informed of the latest news or press releases related to their products. - Help with client requests as needed. - Assist in enabling accurate and timely publishing of all reports by maintaining accuracy of price and chart files and troubleshooting any publishing issues. Benefits - Comprehensive Healthcare Plans. - Paid Time Off. - Retirement Plans. - Comprehensive Insurance Plans. - Lifestyle programs & Wellness Resources. - Education Benefits. - Family Care Benefits & Caregiving Support. - Commuter Transit Program. - Subscription Discounts. - Employee Referral Program.

• Ensure clinical trial site management and monitoring activities in compliance with GCP guidelines, applicable regulations, and SOPs • Execute clinical monitoring activities, including qualification, initiation, routine monitoring, and close-out visits • Maintain Investigator Site Files and Trial Master Files • Implement site management activities in line with trial-specific functional plans • Prepare accurate and timely visit reports • Review trial progress (e.g., patient recruitment, data capture, issue resolution) and initiate appropriate actions • Serve as primary contact for clinical trial supplies and other stakeholders or vendors • Participate in clinical trial team, department and company meetings • Contribute to the development of trial specific documents • Contribute to the continuous improvement of Clinical Operations processes and procedures

Role Description When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Key Accountabilities: - Oversight of Monitoring Responsibilities and Study Conduct - Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality. - Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met. - During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery. - Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level. - Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted in accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies. - Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution. - Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics. - Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues. - Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines. Qualifications - Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations. - Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology). - Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases. - Global clinical trial experience. - Must be fluent in English. - Significant travel across whole Turkey. - Valid driver’s license and passport required. Requirements - Demonstrated knowledge of clinical research and development processes and ability to gain command of process details. - Demonstrated knowledge of global and local regulatory requirements. - Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.). - Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s). - Demonstrated ability to support sponsor regulatory interactions/inspections. - Demonstrated knowledge of the processes around protocol design and feasibility assessment. - Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery. - Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation. Education - Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent.