Syneos Health

<div>Description
Sr CRA II - FSP - Turkey - Homebased
Syneos Health&reg; is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you&rsquo;ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health<ul><li>
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.</li><li>
We are committed to our Total Self culture &ndash; where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.</li><li>
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives &ndash; we&rsquo;re able to create a place where everyone feels like they belong.</li></ul>
Job Responsibilities<ul><li>
Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.</li><li>
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient&rsquo;s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.</li><li>
Per the Clinical Monitoring/Site Management Plan (CMP/SMP):Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records 
Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines 
Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements.</li><li>
May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.</li><li>
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.</li><li>
Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and action items to resolution.</li><li>
Understands project scope, budgets, and timelines for own and others&rsquo; activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.</li><li>
May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.</li><li>
Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in and may lead global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.</li><li>
Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.</li><li>
May provide direct supervision, training and/or mentorship to more junior level CRAs. Performs training and sign off visits for junior CRA staff, as assigned. May be mentored and assigned lead tasks under supervision of an experienced Clinical Operations Lead (COL) or operational line manager. This could include participation in business development proposals and/or defense meetings.</li><li>
For Real World Late Phase (RWLP), the Sr. CRA II will use the business card title of Sr.Site Management Associate II. Additional responsibilities include: 
Site support throughout the study lifecycle from site identification through close-out. Knowledge of local requirements for real world late phase study designs 
Chart abstraction activities and data collection 
As required, collaborate and build relationship with Sponsor and other affiliates, medical science liaisons and local country staff 
The SMA II may be requested to train junior staff 
Identify and communicate out of scope activities to Lead CRA/Project Manager 
Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations. 
Identify operational efficiencies and process improvements 
Develop study and country level informed consent forms 
Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared 
Participate in bid defense meetings 
Provide input into Requests for Proposals (RFPs), scope and budgeting. Develop site management strategy. 
Participate in Case Report Form design and edit check development.</li></ul>
Qualifications:<ul><li>
Bachelor&rsquo;s degree or RN in a related field or equivalent combination of education, training and experience</li><li>
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements</li><li>
Must demonstrate good computer skills and be able to embrace new technologies</li><li>
Excellent communication, presentation and interpersonal skills. Moderate level of critical thinking skills expected.</li><li>
Ability to manage required travel of up to 75% on a regular basis</li></ul>
Get to know Syneos Health 
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you&rsquo;ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
Additional Information 
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. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary
Roles within Clinical Monitoring/CRA job family are responsible for monitoring during clinical research studies to ensure that the trials are being conducted in accordance with widely accepted clinical practices. This includes conducting on-site and remote monitoring, developing tools, procedures, and processes to ensure quality monitoring.Impact and ContributionIndividual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Individual contributor with developing subject matter expertise and responsibility for processes. In-depth knowledge and skills within a professional discipline, understanding the impact of work on related areas. May be responsible for entire projects or processes within area of responsibility.</div>

Sr CRA II - FSP - Turkey - Homebased

<div>Description
CRA II/SCRA, Remote Based- Multi Sponsor
Syneos Health&reg; is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you&rsquo;ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health<ul><li>
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.</li><li>
We are committed to our Total Self culture &ndash; where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.</li><li>
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives &ndash; we&rsquo;re able to create a place where everyone feels like they belong.</li></ul>
Job Responsibilities<ul><li>
Roles within Clinical Monitoring/CRA are responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location. This includes conducting remote monitoring of trial sites to verify compliance with regulatory requirements and clinical protocols. Utilizes data analytics and risk-based monitoring techniques to identify potential issues and trends, ensuring that trials are conducted in accordance with established clinical practices. Collaborates with site teams to develop and implement tools, procedures, and processes that enhance quality monitoring and support the overall success of clinical trials.
Impact and Contribution 
Individual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Established and productive individual contributor. May manage defined components of projects or processes within area of responsibility. Requires practical knowledge of a professional area, typically obtained through education combined with experience.</li><li>
Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.</li><li>
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient&rsquo;s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.</li><li>
Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements.</li><li>
May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.</li><li>
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.</li><li>
Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.</li><li>
For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.</li><li>
May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements</li><li>
Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.</li><li>
Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.</li><li>
Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required.</li></ul>
Qualifications:<ul><li>
Fluency in English and Turkish essential</li><li>
Experience in Oncology as Therapeutic Area essential</li><li>
Bachelor&rsquo;s degree or RN in a related field or equivalent combination of education, training and experience</li><li>
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements</li><li>
Must demonstrate good computer skills and be able to embrace new technologies</li><li>
Excellent communication, presentation and interpersonal skills</li><li>
Ability to manage required travel of up to 75% on a regular basis</li><li>
US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk.</li></ul>
Get to know Syneos Health 
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you&rsquo;ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
Additional Information 
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. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary
Roles within Clinical Monitoring/CRA are responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location. This includes conducting remote monitoring of trial sites to verify compliance with regulatory requirements and clinical protocols. Utilizes data analytics and risk-based monitoring techniques to identify potential issues and trends, ensuring that trials are conducted in accordance with established clinical practices. Collaborates with site teams to develop and implement tools, procedures, and processes that enhance quality monitoring and support the overall success of clinical trials.Impact and ContributionIndividual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Established and productive individual contributor. May manage defined components of projects or processes within area of responsibility. Requires practical knowledge of a professional area, typically obtained through education combined with experience.</div>

CRA II/SCRA, Remote Based- Multi Sponsor

<div>Description
Senior CRA - FSP - Based in KSA - Phase 2, Phase 3 experience is required
Syneos Health&reg; is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you&rsquo;ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health<ul><li>
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.</li><li>
We are committed to our Total Self culture &ndash; where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.</li><li>
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives &ndash; we&rsquo;re able to create a place where everyone feels like they belong.</li></ul>
Job Responsibilities<h1 class="jobSectionHeader">
Senior CRA - FSP (Single Sponsor)</h1><h1 class="jobSectionHeader">
Phase 2, Phase 3 experience is required</h1><h1 class="jobSectionHeader">
ONLY CANDIDATES FROM KSA WHO HAS VALID WORKING VISA</h1><ul><li>
Conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices, including reviewing study protocols, informed consent forms, and case report forms</li><li>
Develop and implement tools, procedures, and processes to ensure quality monitoring, such as creating monitoring plans, checklists, and templates</li><li>
Contribute to the design, implementation, and delivery of processes, programs, and policies, including participating in the development of standard operating procedures (SOPs) and training materials</li><li>
Manage defined components of projects or processes within the area of responsibility, such as coordinating site visits, tracking study progress, and resolving issues</li><li>
Ensure accurate and timely documentation of monitoring activities and findings, including writing monitoring reports, follow-up letters, and action plans</li><li>
Collaborate with cross-functional teams to support clinical trial operations, including working with investigators, site staff, and other stakeholders to ensure smooth study conduct</li></ul>
Qualifications:<ul><li>
Bachelor's degree in a related field or equivalent experience</li><li>
Minimum of 2-4 years of experience in clinical research monitoring</li><li>
Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements</li><li>
Excellent communication and interpersonal skills</li><li>
Ability to work independently and manage multiple priorities</li><li>
Proficiency in using clinical trial management systems and other relevant software</li></ul>
Certifications:<ul><li>
Certified Clinical Research Associate (CCRA) or equivalent certification preferred</li></ul>
Necessary Skills:<ul><li>
Attention to detail and strong analytical skills</li><li>
Problem-solving abilities and critical thinking</li><li>
Ability to work effectively in a team environment</li><li>
Strong organizational and time management skills</li><li>
Proficiency in Microsoft Office Suite</li></ul>
Get to know Syneos Health 
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you&rsquo;ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
Additional Information 
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. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary
Roles within Clinical Monitoring/CRA job family at the P21 level are responsible for ensuring that clinical research studies are conducted in accordance with widely accepted clinical practices. This includes conducting on-site and remote monitoring, developing tools, procedures, and processes to ensure quality monitoring. These roles involve individual contributors with responsibility in a professional or technical discipline or specialty, and may manage two or fewer employees. The majority of time is spent contributing to the design, implementation, or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education.Impact and ContributionRoles within Clinical Monitoring/CRA job family at the P21 level have a significant impact on the quality and integrity of clinical research studies. By ensuring adherence to clinical practices and protocols, these roles contribute to the reliability and validity of study results. They play a crucial role in the development and implementation of monitoring tools and procedures, which enhance the overall efficiency and effectiveness of clinical trials. Their contributions are essential for advancing medical knowledge and improving patient outcomes.Core Focus&bull;Conduct thorough on-site and remote monitoring of clinical research studies&bull;Develop and implement tools, procedures, and processes to ensure quality monitoring&bull;Manage defined components of projects or processes within their area of responsibility&bull;Utilize practical knowledge of a professional area, typically obtained through education combined with experience&bull;Maintain high standards of clinical practice and ensure the success of clinical trials</div>

Senior CRA - FSP - Based in KSA - Phase 2, Phase 3 experience is required

Thermo Fisher Scientific

<div>Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
At Thermo Fisher Scientific, you&rsquo;ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on &ndash; now and in the future.<h2 class="jobSectionHeader">
Discover Impactful Work:</h2>
Our global Clinical Operations colleagues within our PPD&reg; clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and complete high-quality, cost-efficient clinical studies.<h2 class="jobSectionHeader">
A day in the Life:</h2><ul><li>
Thrive in multi-national project teams and be focused on delivering exemplary levels of customer service on multiple, exciting projects.</li><li>
Have excellent communication and social skills and are looking to work in a collegiate environment where you want to take true ownership for your work.</li><li>
Perform and coordinate all aspects of the clinical monitoring process. You shall also be qualified to conduct monitoring activities independently.</li><li>
Benefit from award winning training programmes that will assist your technical and professional skills and knowledge.</li></ul><h2 class="jobSectionHeader">
Keys to Success:</h2><h2 class="jobSectionHeader">
Education</h2><ul><li>
University degree in a life-sciences field</li></ul><h2 class="jobSectionHeader">
Experience</h2><ul><li>
Experience of independent, on-site monitoring experience in a Pharmaceutical or Clinical Research Organisation</li></ul><h2 class="jobSectionHeader">
Knowledge, Skills, Abilities</h2><ul><li>
Demonstrated understanding of ICH-GCP, EU and FDA requirements</li><li>
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology</li><li>
Exceptional communication, collaboration, organisational and time management skill</li><li>
Fluency in Turkish and English languages</li></ul></div>

Clinical Research Associate (CRA) - Client-dedicated

AstraZeneca

<div>
 At AstraZeneca, we unlock the power of what science can do. Empowered to explore, everyday we work towards our ultimate aim &ndash; treating, preventing, modifying and even curing complex diseases. With an unwavering belief in following the science, we unleash our curiosity. Investing in key areas, harnessing innovative technologies and taking smart risks. Help to shape the future of healthcare as we take our pipeline from strength to strength. Embrace an environment built on lifelong learning. Never complacent, we seek opportunities to expand our knowledge. The place to build a long-term meaningful career. Here we get to develop and grow &ndash; whether that&rsquo;s working at the leading-edge or on varied stages and molecules. Working on things that have never been done before. In return, when great science comes alive, we have the opportunity to get published. We stand together behind a shared ambition. United by our collective passion for having a positive impact on patients&rsquo; lives. Important work that is both meaningful and fulfilling. With the potential to reach over a billion patients across the globe who are living with these complex diseases.
 
 
 
 Background &amp; Qualifications
 
 
 
 <ul>
 <li>
 University degree, preferably from Healthcare related areas (Pharmacy, Veterinary, Chemistry, Biology, Medical etc. Faculties),
 </li>
 <li>
 Good level of English,
 </li>
 <li>
 Minimum 1 year of experience in a CRA and/or study coordinator positions
 </li>
 <li>
 Strong communication and negotiation skills,
 </li>
 <li>
 Ability to prioritize and handle multiple tasks,
 </li>
 <li>
 Effective planning and organizational skills with a result-oriented approach,
 </li>
 <li>
 Analytical thinking, critical reasoning ability,
 </li>
 <li>
 Good command of MS Office applications,
 </li>
 <li>
 No restriction to travel,
 </li>
 <li>
 Driving License,
 </li>
 <li>
 No military obligation for male candidates.
 
 
 </li>
 </ul>
 
 Job Description
 
 
 
 <ul>
 <li>
 Perform monitoring and site management activities for phase trials projects to assess the progress of clinical projects at assigned investigative/physician sites
 </li>
 <li>
 Ensure clinical project is conducted, recorded, and reported in accordance with the protocol, Company SOPs, ICH-GCP, and all applicable local and legal requirements.
 </li>
 <li>
 May assume clinical functional leadership tasks are assigned, actions as Lead CRA for project
 </li>
 <li>
 Train, support and advise Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
 </li>
 <li>
 Drive performance at the sites. Proactively identify and ensure timely resolution to study-related issues and escalate them as appropriate.
 </li>
 <li>
 Perform regular Site Quality Risk Assessments and adapt monitoring intensity accordingly during the study.
 </li>
 <li>
 Ensure data query resolution in a timely manner.
 </li>
 <li>
 Work with data management to ensure the robust quality of the collected study data.
 </li>
 <li>
 Collaborate with local MSLs as directed by LSM or line manager.
 
 
 </li>
 </ul>
 
 Why AstraZeneca?
 
 
 
 A high performing team, we work hard to not just meet but go beyond the needs of patients and the wider healthcare industry We leverage our partnerships with external experts across the industry, to create and communicate evidence that changes medical practice. As a partner for many, we effectively communicate complex ideas whilst seeking to understand ever-changing needs and requirements. Our valuable contribution and scientific expertise is responsible for advancing our pipeline and accelerating our pathway to finding a cure. Are you already imagining yourself joining our team? Good, because we can&rsquo;t wait to hear from you.
 
 
 
 Where can I find out more?
 
 
 
 Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
 
 
 Follow AstraZeneca on Instagram https://www.instagram.com/astrazenecaturkiyekariyer/
 
 
 
 Date Posted
 
 
 
 23-Tem-2025
 
 
 
 Closing Date
 
 
 
 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
</div>

Clinical Research Associate (Biopharma)

Medpace

<div>
 
 Launch or Accelerate Your Career in Clinical Research at Medpace India
 
 
 
 At Medpace, we&rsquo;re a global clinical research organization committed to bringing new medicines to patients. In India (Hyderabad &amp; Mumbai/Navi Mumbai), we&rsquo;re expanding our clinical operations, safety, and data teams &mdash; and we&rsquo;re looking for professionals with a nursing background to drive that growth.
 
 
 If you&rsquo;re looking for a new challenge, and want to be part of building something meaningful while advancing your career with a company that&rsquo;s investing in your region &mdash; we&rsquo;d love to hear from you.
 
 
 
 Help shape the future of Medpace. Apply today.
 
 
 
 
 Responsibilities
 
 
 
 
 Why your nursing background matters:
 
 
 
 As a nurse, you&rsquo;ve already developed critical clinical judgement, patient-care experience, and strong understanding of healthcare workflows. At Medpace, these strengths are exactly what we&rsquo;re seeking to apply in roles such as:
 
 
 <ul>
 <li>
 Clinical Safety / Drug Safety Coordinator
 </li>
 <li>
 Study Coordinator / Study Start-Up Specialist
 </li>
 <li>
 Clinical Research Associate (CRA)
 </li>
 <li>
 Clinical Data Review Associate
 </li>
 <li>
 Data Coordinator
 </li>
 <li>
 Clinical Data Coder
 
 
 </li>
 </ul>
 
 What you&rsquo;ll do (depending on role):
 
 
 
 <ul>
 <li>
 Monitor and ensure the safety of clinical trial participants, report adverse events, and contribute to patient-safety outcomes.
 </li>
 <li>
 Liaise with trial sites, healthcare professionals, and cross-functional teams to support protocol conduct and compliance.
 </li>
 <li>
 Use your clinical experience to review and interpret patient/clinical data, identify inconsistencies or queries, and support high-quality trial documentation.
 </li>
 <li>
 Shift your career from direct patient care into the broader clinical-research ecosystem &mdash; working on global studies, gaining new skills and advancing in your career.
 
 
 </li>
 </ul>
 
 What&rsquo;s in it for you:
 
 
 
 <ul>
 <li>
 A real career path: from specialist roles into senior roles (e.g., Senior CRA, Lead Safety Specialist).
 </li>
 <li>
 Work in a global CRO with a strong reputation and clinical focus.
 </li>
 <li>
 Be based in Hyderabad or Navi Mumbai &mdash; vibrant locations with exciting growth opportunities.
 </li>
 <li>
 Competitive salary and benefits &mdash; plus the chance to make a meaningful impact, not just for patients &mdash; but also for your personal career journey.
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 
 What we expect from you:
 
 
 
 <ul>
 <li>
 Bachelor of Science in Nursing (BSN) or higher (MSc Nursing preferred).
 </li>
 <li>
 Clinical experience in a hospital or healthcare setting.
 </li>
 <li>
 Excellent communication skills (verbal and written), and comfort collaborating across functional teams.
 </li>
 <li>
 A proactive, growth-oriented mindset: you&rsquo;re ready to apply your nursing skill-set in a new way, and you&rsquo;re motivated to learn and take on global responsibilities.
 </li>
 <li>
 Prior exposure to clinical research is a plus &mdash; but not required. We offer training and support to help you step into the role.
 
 
 </li>
 </ul>
 
 Medpace Overview
 
 
 
 Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
 
 
 
 Why Medpace?
 
 
 
 People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
 
 
 The work we&rsquo;ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
 
 
 
 Medpace Perks
 
 
 
 <ul>
 <li>
 Flexible work environment
 </li>
 <li>
 Competitive compensation and benefits package
 </li>
 <li>
 Competitive PTO packages
 </li>
 <li>
 Structured career paths with opportunities for professional growth
 </li>
 <li>
 Company-sponsored employee appreciation events
 </li>
 <li>
 Employee health and wellness initiatives
 
 
 </li>
 </ul>
 
 Awards
 
 
 
 <ul>
 <li>
 Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
 </li>
 <li>
 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
 
 
 </li>
 </ul>
 
 What To Expect Next
 
 
 
 A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
</div>

Nursing Educated Professionals (BSN or higher)

IQVIA

<div>
 
 Clinical Research Associate
 
 
 
 
 IQVIA Turkey
 
 is looking for talented and motivated team member to join our Sponsor dedicated team as junior CRA. At this position you will have the opportunity to put your passions to work in an environment designed to help you gain experience in a wide variety of therapeutic areas, and build a meaningful, strong career within our organization.
 
 
 
 Your Responsibilities Will Include
 
 
 
 <ul>
 <li>
 Performing site selection, initiation, monitoring and close-out visits
 </li>
 <li>
 Supporting the development of a subject recruitment plan
 </li>
 <li>
 Evaluating the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice and International Conference on Harmonization guidelines
 </li>
 <li>
 Managing progress by tracking regulatory submissions, recruitment, case report form completion, and data query resolutions
 </li>
 <li>
 Collaborating with experts at study sites and with client representatives
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 <ul>
 <li>
 University degree in scientific discipline or health care
 </li>
 <li>
 Requires at least 1 year of on-site monitoring experience.
 </li>
 <li>
 Experience in Pharma Industry, and/or Clinical Trials environment
 </li>
 <li>
 Very good computer skills including MS Office
 </li>
 <li>
 Excellent command of Turkish and English language, Turkey based
 </li>
 <li>
 Organizational, time management and problem-solving skills
 </li>
 <li>
 Ability to establish and maintain effective working relationships with co-workers, managers, and clients
 </li>
 <li>
 Flexibility to travel
 </li>
 <li>
 Driver&rsquo;s license class B
 
 
 </li>
 </ul>
 
 What You Can Expect
 
 
 
 <ul>
 <li>
 Resources that promote your career growth
 </li>
 <li>
 Leaders that support flexible work schedules
 </li>
 <li>
 Programs to help you build your therapeutic knowledge
 </li>
 <li>
 Excellent working environment in a stabile, international, reputable company
 </li>
 <li>
 Company car, mobile phone and attractive benefits package
 
 
 </li>
 </ul>
 This role is suitable for disabled individuals. Priority will be given to candidates registered with &Idot;&Scedil;KUR.
 
 
 IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
</div>

Experienced Clinical Research Associate - Sponsor dedicated - Türkiye

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