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clinical research associate ii Jobs in Turkey

clinical research associate ii

pharmacovigilance specialist

MSD Türkiye

<div>
 
 Job Description
 
 
 
 At our company, we are dedicated to advancing the prevention and treatment of diseases in people and animals through innovative health solutions. As a premier research-intensive biopharmaceutical company, we are seeking a passionate and detail-oriented Pharmacovigilance Specialist to join our team. This role offers the opportunity to contribute to our mission of saving and improving lives around the world through leading-edge science.
 
 
 
 How You&rsquo;ll Make An Impact
 
 
 
 <ul>
 <li>
 Conduct PV Intake activities, including reconciliation and follow-up to ensure patient safety.
 </li>
 <li>
 Perform individual case safety report (ICSR) and aggregate submissions for comprehensive safety monitoring.
 </li>
 <li>
 Support audits and inspections, ensuring readiness and compliance.
 </li>
 <li>
 Author local SOPs and drive local training initiatives.
 </li>
 <li>
 Escalate safety issues promptly and manage archiving with precision.
 </li>
 <li>
 Participate in additional activities and impactful projects overseen by your manager.
 
 
 </li>
 </ul>
 
 Required
 
 
 
 
 What You Bring to the Team
 
 
 
 <ul>
 <li>
 Physician/pharmacist degree or equivalent by education/experience.
 </li>
 <li>
 Fluency in English and proficiency in Turkish.
 </li>
 <li>
 General knowledge of PV regulations within the assigned country.
 </li>
 <li>
 Expertise in PV processes and activities.
 </li>
 <li>
 Strong communication and time management skills.
 </li>
 <li>
 Ability to prioritize assignments and work independently with minimal supervision.
 </li>
 <li>
 Proficiency in Microsoft Office (Word, Excel, PowerPoint, etc.).
 </li>
 <li>
 Capability to learn new computer interface systems and familiarity with safety databases.
 
 
 </li>
 </ul>
 
 Required Skills
 
 
 
 Adverse Event Report, Communication, Computer Literacy, Detail-Oriented, Microsoft Office, Pharmacovigilance, Regulatory Compliance
 
 
 
 Preferred Skills
 
 
 
 Current Employees apply HERE
 
 
 Current Contingent Workers apply HERE
 
 
 
 Search Firm Representatives Please Read Carefully
 
 
 
 Merck &amp; Co., Inc., Rahway, NJ, USA, also known as Merck Sharp &amp; Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
 
 
 
 Employee Status
 
 
 
 Regular
 
 
 
 Relocation
 
 
 
 
 VISA Sponsorship
 
 
 
 
 Travel Requirements
 
 
 
 
 Flexible Work Arrangements
 
 
 
 Hybrid
 
 
 
 Shift
 
 
 
 
 Valid Driving License
 
 
 
 
 Hazardous Material(s)
 
 
 
 
 Job Posting End Date
 
 
 
 05/12/2026
 
 
 <ul>
 <li>
 A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
 
 
 </li>
 </ul>
 
 Requisition ID
 
 R395467
</div>

Pharmacovigilance Specialist

<div>Job Description
At our company, we are dedicated to advancing the prevention and treatment of diseases in people and animals through innovative health solutions. As a premier research-intensive biopharmaceutical company, we are seeking a passionate and detail-oriented Pharmacovigilance Specialist to join our team. This role offers the opportunity to contribute to our mission of saving and improving lives around the world through leading-edge science.
How You&rsquo;ll Make an Impact<ul><li>
Conduct PV Intake activities, including reconciliation and follow-up to ensure patient safety.</li><li>
Perform individual case safety report (ICSR) and aggregate submissions for comprehensive safety monitoring.</li><li>
Support audits and inspections, ensuring readiness and compliance.</li><li>
Author local SOPs and drive local training initiatives.</li><li>
Escalate safety issues promptly and manage archiving with precision.</li><li>
Participate in additional activities and impactful projects overseen by your manager.</li></ul>
What You Bring to the Team
Required<ul><li>
Physician/pharmacist degree or equivalent by education/experience.</li><li>
Fluency in English and proficiency in Turkish.</li><li>
General knowledge of PV regulations within the assigned country.</li><li>
Expertise in PV processes and activities.</li><li>
Strong communication and time management skills.</li><li>
Ability to prioritize assignments and work independently with minimal supervision.</li><li>
Proficiency in Microsoft Office (Word, Excel, PowerPoint, etc.).</li><li>
Capability to learn new computer interface systems and familiarity with safety databases.</li></ul>
Required Skills:
Adverse Event Report, Communication, Computer Literacy, Detail-Oriented, Microsoft Office, Pharmacovigilance, Regulatory Compliance
Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully 
Merck &amp; Co., Inc., Rahway, NJ, USA, also known as Merck Sharp &amp; Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
05/12/2026<ul><li>A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. 
</li></ul> 
Requisition ID:R395467</div>

IQVIA

<div>Istanbul, Turkey | Full time | Home-based | R1539341</div>
 <div><h2 class="jobSectionHeader">Use your scientific and foreign language expertise to join the world&rsquo;s leading comprehensive pharmaceutical safety services organization at on a fast-growing team performing medical information call center services. Apply your knowledge and expertise, including complex decision making, to review, assess and process safety and product quality information. Be a part of a global team to help ensure the safety profiles of products marketed around the world with development opportunities to ultimately provide oversight on projects and teams.
</h2><h2 class="jobSectionHeader">RESPONSIBILITIES</h2><ul><li><h2 class="jobSectionHeader">
Provide phone support to health care professionals and consumers regarding adverse events, product quality complaints, medical inquiries, product support, and other needs as required. This does NOT include commercial sales support.</h2></li><li><h2 class="jobSectionHeader">
Receive, triage, review and process Lifecycle safety operational data. Perform data entry for tracking and Lifecycle safety databases, coding relevant medical terminology, writing descriptive narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations.</h2></li><li><h2 class="jobSectionHeader">
Receive and document incoming telephone calls or emails from investigative sites or other sources reporting safety data.</h2></li><li><h2 class="jobSectionHeader">
Build a positive, collaborative team environment with Lifecycle safety team members, lead by example, provide training and mentoring for less experienced team members and operations staff.</h2></li><li><h2 class="jobSectionHeader">
Establish and maintain effective team project service operations communications
</h2></li><li><h2 class="jobSectionHeader">Liaise with Project Manager by proactively identifying issues and proposing solutions</h2></li><li><h2 class="jobSectionHeader">
Participate in training across Lifecycle safety process service offerings, participate in working groups as applicable in implementation of new initiatives</h2></li></ul><h2 class="jobSectionHeader">
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES</h2><ul><li><h2 class="jobSectionHeader">
Life Sciences Degree</h2></li><li><h2 class="jobSectionHeader">
Excellent written and verbal skills in Lithuanian, English and other foreign language.</h2></li><li><h2 class="jobSectionHeader">
Willingness and aptitude to learn new skills across our Lifecycle Safety service lines.</h2></li><li><h2 class="jobSectionHeader">
Excellent attention to detail and accuracy maintaining consistently high-quality standards.</h2></li><li><h2 class="jobSectionHeader">
Excellent organizational skills and time management skills.</h2></li><li><h2 class="jobSectionHeader">
Ability to establish and maintain effective working relationships with coworkers, managers and clients.</h2></li><li><h2 class="jobSectionHeader">
Ability to work effectively on multiple projects simultaneously, organize own workload and effectively manage competing priorities.</h2></li></ul><h3 class="jobSectionHeader">
This role is not available for UK visa sponsorship</h3><div>
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><div>
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.</div></div>

Medical Information and Adverse Event Intake Specialist with Lithuanian, English and additional foreign language

MPH Global Services

<div><div><div>Industry: Oil &amp; Gas 
City/Country: Jubail, Saudi Arabia 
Location: Jubail</div></div><div></div><div><ul><li> 
Verify and validate Contractor technical preparation for welding activities, relevant project documents and dossiers.</li><li>Monitor and support the EPCC package Contractor and third Parties in the execution of their responsibilities under the contract requirements. Follow the corresponding close-out.</li><li>Ensure that the project deliverables, equipment, and facilities are designed and engineered in accordance with the codes, specifications &amp; standards, technical referential, Status of Requirements, contract, main local regulations, job/duty/scope requirements. Follow the corresponding close-out.</li><li>Work closely with other Company and Contractor Engineering discipline Leaders.</li><li>Main internal interfaces are with Static equipment specialist, Piping specialist, Rotating specialist, Instrumentation specialist, Corrosion specialist, Quality team, and Inspection representatives.</li><li>Main external interfaces are with Contractor discipline Leads, Contractor welding Engineers, Contractor NDT Specialists, Contractor quality representatives.</li><li>Follow up execution of engineering, procurement and construction activities.</li><li>Participate actively in overall engineering meetings, documentation reviews, schedule, planning and optimization activities.</li><li>Review of Welding Dossiers, Weld maps, NDE matrixes, WPS/PQR, Laboratory test reports, PWHT procedures, Material Purchase Specifications.</li><li>Review NDT Procedures, Inspection and Tests Plans, Fabrication Quality Control Plan, Preservation procedures.</li><li>Review Material Selection Diagram.</li><li>Witness Welding Procedure Qualification, production test coupons when necessary.</li><li>Carry out and participate to project and Shareholders internal and external general reviews and audits. Follow the corresponding close-out for Welding activities.</li><li>To review and provide technical out-put recommendations for Non-Conformance Reports, Technical queries, and Waiver requests according to project procedures.</li><li>Support the project Management of Change and the Change of Scope activities.</li><li>Carry out site activities during the project execution to support the design and engineering of the equipment, packages, and facilities.</li><li>Registration as International Welding Engineer shall be considered as a plus.</li><li>Experience in refining or petrochemicals industries and static equipment Manufacturers.</li><li>Proven Experience in EPC project as Welding Specialist.</li><li>Experience of applicable codes and standards such as ASME VIII, ASME B31.3, ASME IX, ASME V, API, ASTM, NACE, AWS, EN/ISO, emphasis in Welding and Non-Destructive Testing of weldments.</li><li>Experience with the welding of C/Mn steels, LTCS, LAS, Stainless Steels (including Duplex and Super Duplex) and Nickel Alloys.</li><li>Experience with NDT methods (RT, PT, MT, UT, PAUT&hellip;) formal certification is a plus.</li><li>Knowledgeable to filler metal selection for homogeneous and dissimilar welds parent metals.</li><li>Experience in integrated projects and joint Venture organizations is a plus.</li><li>Knowledge of safety and environmental aspects of major construction projects.</li><li>Ability to adapt to changes and to work in an international multi-cultural project environment, to cope in a positive and productive manner within intensive environment. Interpersonal skills, rigor, and analytical mind.</li><li>Ability to work as a member of a project Team, to liaise, coordinate and positively communicate with the involved different Parties (Contractors, project Entities, Authorities, industrial Investors, nearby Industries, auditors, other disciplines representatives, experts, etc.). Ability to liaise effectively at all organizational levels.</li><li>Leadership in a challenging context.</li><li>Oral communication abilities and writing skills in the English language required.</li></ul></div></div><div></div>

Welding Specialist Engineer

サイネオス・ヘルス

<div><div><div>Updated: Yesterday 
Location: Nida Kule Iş Merkezi G&ouml;ztepe, 34, Turkey 
Job ID: 25107030
<div><div>Not ready to apply? 
Join our Talent Network
</div></div><div>Description
CRA II - Fully Homebased - Open for any City in Turkey - FSO/FSP<div>
Syneos Health&reg; is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. 
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
 
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 deliver &ndash; for one another, our customers, and, most importantly, for those in need.
 
 
Discover what your 25,000 future colleagues already know:
 
 
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 building an inclusive culture &ndash; where you can authentically be yourself. Central to this is our purpose &ndash; Driven to Deliver &ndash; which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone&rsquo;s life.
</li><li>We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.</li></ul></div>
Job Responsibilities<ul><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. For Real World Late Phase, the CRA II will use the business card title of 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 
Collaboration with Sponsor 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.</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</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 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.</div></div></div></div><div></div>

CRA II - Fully Homebased - Open for any City in Turkey - FSO/FSP

Blync

Remote SEO Specialist (WordPress &amp; Webflow Uzmanı)Uzaktan &ccedil;alışacak, deneyimli ve sonu&ccedil; odaklı bir SEO Specialist arıyoruz. Global projelerde aktif rol alacak, teknik ve stratejik anlamda g&uuml;&ccedil;l&uuml; bir ekip arkadaşı arıyoruz.Genel NiteliklerSEO alanında en az 4 yıl deneyimWordPress ve Webflow platformlarında ileri d&uuml;zey bilgi ve deneyimTeknik SEO, On-Page ve Off-Page SEO konularına hakimGoogle Analytics, Google Search Console ve Google Ads ara&ccedil;larını aktif kullanabilenAnahtar kelime araştırması, i&ccedil;erik optimizasyonu ve rakip analizi konusunda deneyimliSite hız optimizasyonu ve Core Web Vitals bilgisi olanTemel HTML &amp; CSS bilgisi (tercihen)Analitik d&uuml;ş&uuml;nme ve d&uuml;zenli raporlama yeteneği g&uuml;&ccedil;l&uuml;Dil Gereksinimi (&Ouml;NEMLİ)İngilizce ileri seviye (konuşma ve yazma zorunlu)T&uuml;m m&uuml;şterilerimiz İngilizce konuşmaktadır; adayın aktif iletişim kurabilecek seviyede İngilizce bilmesi gerekmektedirSorumluluklarWeb sitelerinin SEO performansını artırmakWordPress ve Webflow projelerinde SEO optimizasyonlarını y&uuml;r&uuml;tmekGoogle Ads kampanyalarını y&ouml;netmek ve optimize etmekAnahtar kelime ve i&ccedil;erik stratejileri oluşturmakTeknik SEO sorunlarını tespit edip &ccedil;&ouml;zmekD&uuml;zenli performans raporları hazırlamak ve yorumlamakArtı OlarakUluslararası projelerde deneyimE-ticaret SEO bilgisiBacklink ve otorite artırma stratejilerinde tecr&uuml;be&Ccedil;alışma Şartları%100 Remote (uzaktan &ccedil;alışma)Esnek &ccedil;alışma saatleriUzun d&ouml;nemli işbirliği imkanıWork Location: Remote

seo uzmani

<div><div><div>Updated: Yesterday 
Location: Nida Kule Iş Merkezi G&ouml;ztepe, 34, Turkey 
Job ID: 25107463
<div><div>Not ready to apply? 
Join our Talent Network
</div></div><div>Description
Site Care Partner I (SrCRA) - FSP, Sponsor Dedicated<div>
Syneos Health&reg; is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. 
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
 
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 deliver &ndash; for one another, our customers, and, most importantly, for those in need.
 
 
Discover what your 25,000 future colleagues already know:
 
 
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 building an inclusive culture &ndash; where you can authentically be yourself. Central to this is our purpose &ndash; Driven to Deliver &ndash; which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone&rsquo;s life.
</li><li>We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.</li></ul></div>
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 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. 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></div></div></div><div></div>

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