IQVIA

<div>
 
 
 IQVIA Biotech is now hiring for CRA 1 with a minimum of 6 months of on-site monitoring. Must have experience monitoring in oncology solid tumor.
 
 
 
 
 
 IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience, we offer agile, therapeutically aligned solutions and trusted partnerships that help bring breakthrough treatments to patients faster.
 
 
 
 
 Job Overview
 
 
 
 The Clinical Research Associate I (CRA I) plays a key role in supporting the successful conduct of clinical research studies by performing site monitoring and site management activities. In this position, you will ensure that assigned study sites conduct trials in compliance with the protocol, applicable regulations, Good Clinical Practice (GCP), and ICH guidelines. This role is essential in protecting patient safety, ensuring high‑quality clinical data, and maintaining study integrity.
 
 
 
 Key Responsibilities
 
 
 
 As a CRA I, you will conduct various types of monitoring visits&mdash;including site selection, initiation, routine monitoring, and close‑out visits&mdash;to evaluate the quality and integrity of site practices. You will verify that study activities are performed according to regulatory requirements and sponsor expectations, escalating quality concerns as necessary. During these visits, you will review essential documents, assess protocol adherence, oversee data entry and query resolution, and ensure maintenance of both the Trial Master File (TMF) and the Investigator Site File (ISF).
 
 
 A central part of this role involves building and maintaining strong communication with investigative sites. You will provide protocol training, set expectations, address site‑level challenges, and support recruitment planning to help sites meet enrollment targets. You will also collaborate closely with internal project teams to ensure cohesive study execution and may contribute to site-level financial processes or start‑up activities based on study needs.
 
 
 Accurate and timely documentation is critical. The CRA I prepare detailed monitoring visit reports, follow‑up letters, and all required study documentation to ensure audit readiness and transparent oversight. The ability to manage multiple tasks, prioritize effectively, and work independently while maintaining productive team relationships is essential for success.
 
 
 
 Qualifications
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree required; a scientific or healthcare discipline is preferred.
 </li>
 <li>
 6 months &ndash;2 years of relevant experience, with equivalent combinations of education, training, or completion of a CRA training program considered.
 </li>
 <li>
 Basic knowledge of clinical research regulations (GCP/ICH).
 </li>
 <li>
 Ability to travel as required by the project.
 
 
 </li>
 </ul>
 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
 
 
 IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
 
 
 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.
 
 
 The potential base pay range for this role, when annualized, is $71,900.00 - $119,900.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
</div>

CRA 1, IQVIA Biotech

Thermo Fisher Scientific

<div>Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as a Clinical Research Associate (Level II) &ndash; Make an Impact at the Forefront of Innovation 
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. 
 
 
 
As part of our global team, you&rsquo;ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix. 
 
What You&rsquo;ll Do: 
<ul><li>Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.</li><li>Participates in investigator meetings as necessary. Identifies potential
</li><li>investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.</li><li>Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
</li><li>Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).</li><li>Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.</li><li>Responds to company, client and applicable regulatory requirements/audits/inspections.
</li><li>Maintains &amp; completes administrative tasks such as expense reports and timesheets in a timely manner.</li><li>Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.</li><li>Contributes to other project work and initiatives for process improvement, as required.</li></ul> 
Education and Experience Requirements:
 
<ul><li>Bachelor's degree in a life sciences related fieldor a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.</li><li>Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship.
</li><li>Valid driver's license where applicable.</li></ul>
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
 
 
Knowledge, Skills and Abilities:
 
<ul><li>Proven clinical monitoring skills</li><li>Demonstrated understanding of medical/therapeutic area knowledge and medical terminology</li><li>Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents</li><li>Well-developed critical thinking skills, including but not limited to: critical mindset, in-depthinvestigation for appropriate root cause analysis and problem solving</li><li>Ability to manage Risk Based Monitoring concepts and processes</li><li>Good oral and written communication skills, with the ability to communicate effectively with medical personnel</li><li>Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers&rsquo; underlying issues</li><li>Good organizational and time management skills</li><li>Effective interpersonal skills</li><li>Attention to detail</li><li>Ability to remain flexibile and adaptable in a wide range of scenarios</li><li>Ability to work in a team or independently as required</li><li>Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software</li><li>Good English language and grammar skills</li><li>Good presentation skills</li></ul> 
Working Conditions and Environment:
 
<ul><li>Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.</li><li>Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays.
</li><li>Exposure to biological fluids with potential exposure to infectious organisms.
</li><li>Personal protective equipment required such as protective eyewear, garments and gloves.
</li><li>Exposure to fluctuating and/or extreme temperatures on rare occasions</li></ul></div>

CRA II

Medpace

<div>
 
 Clinical Research Coordinators wanted at Medpace! Become a CRA and join our growing team!
 
 
 
 This is an exciting opportunity for clinical research professionals with at least one year of Clinical Research Coordinator experience to fill Clinical Research Associate (CRA) openings with Medpace. Through our
 
 PACE&reg;
 
 Training Program, you will receive the training needed to become a fully functional CRA with the opportunity to work home-based. You will also have the opportunity to earn a generous travel bonus in addition to a competitive salary.
 
 
 
 WE OFFER THE FOLLOWING
 
 
 
 <ul>
 <li>
 Competitive travel bonus;
 </li>
 <li>
 Equity/Stock Option program;
 </li>
 <li>
 Training completion and retention bonus
 </li>
 <li>
 Annual merit increases;
 </li>
 <li>
 401K matching;
 </li>
 <li>
 The opportunity to work from home;
 </li>
 <li>
 Flexible work hours across days within a week;
 </li>
 <li>
 Retain airline reward miles and hotel reward points;
 </li>
 <li>
 Home office furniture allowance, laptop, mobile phone with hotspot for internet access anywhere;
 </li>
 <li>
 In-house travel agents, reimbursement for airline club, and TSA pre-check;
 </li>
 <li>
 Opportunity for leadership positions &ndash; Lead CRA, CRA Manager, Clinical Trial Manager, Training and Development Manager, and many more;
 </li>
 <li>
 CRA training program (PACE&reg;);
 </li>
 <li>
 Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts;
 </li>
 <li>
 In-house administrative support for all levels of CRAs; and
 </li>
 <li>
 Opportunities to work with international team of CRAs.
 
 
 </li>
 </ul>
 
 Responsibilities
 
 
 
 <ul>
 <li>
 Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;
 </li>
 <li>
 Communication with the medical site staff including coordinators, clinical research physicians, and their site staff;
 </li>
 <li>
 Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
 </li>
 <li>
 Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements;
 </li>
 <li>
 On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward;
 </li>
 <li>
 Verification that the investigator is enrolling only eligible subjects;
 </li>
 <li>
 Regulatory document review;
 </li>
 <li>
 Medical device and/or investigational product/drug accountability and inventory;
 </li>
 <li>
 Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
 </li>
 <li>
 Assess the clinical research site&rsquo;s patient recruitment and retention success and offering suggestions for improvement; and
 </li>
 <li>
 Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 <ul>
 <li>
 Must have a minimum of a Bachelor&rsquo;s degree in a health or science related field;
 </li>
 <li>
 Experience as a Clinical Research Coordinator (minimum 1 year);
 </li>
 <li>
 Ability to travel 60-70% to locations nationwide is required; some visits may be conducted remotely
 </li>
 <li>
 Must maintain a valid driver&rsquo;s license and the ability to drive to monitoring sites;
 </li>
 <li>
 Proficient knowledge of Microsoft&reg; Office;
 </li>
 <li>
 Strong communication and presentation skills; and
 </li>
 <li>
 Must be detail-oriented and efficient in time management.
 
 
 </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 PTO packages &ndash; starting at 20+ days
 </li>
 <li>
 Company-sponsored employee appreciation events
 </li>
 <li>
 Employee health and wellness initiatives
 </li>
 <li>
 Competitive compensation and benefits package
 </li>
 <li>
 Structured career paths with opportunities for professional growth
 </li>
 <li>
 Discounts for local businesses
 
 
 </li>
 </ul>
 
 Awards
 
 
 
 <ul>
 <li>
 Named a Top Workplace in 2024 by The Cincinnati Enquirer
 </li>
 <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>

Clinical Research Coordinator to Home-Based CRA (Clinical Research Associate)

Bright Uro

About Bright Uro: Bright Uro is a fast-growing medical device startup headquartered in Irvine, CA, on a mission to improve the lives of millions affected by lower urinary tract symptoms (LUTS). We develop cutting-edge diagnostic technology that integrates advanced hardware, intuitive software, and powerful data analytics &mdash; enabling clinicians to gain actionable insights while delivering a better patient experience. We're passionate about advancing urologic care through innovation, and we're building a collaborative, dynamic team to bring transformative solutions to life. About the Role: The Clinical Research Associate I (CRA I) is an exciting entry point into the world of clinical research at Bright Uro, offering hands-on exposure across the full lifecycle of a clinical study &mdash; from site identification and initiation through data collection and study close-out. As a CRA I, you'll work at the intersection of science, patient care, and regulatory rigor. You'll collaborate closely with investigational sites, clinicians, and internal teams to ensure studies are conducted with integrity, precision, and compliance. Whether you're providing real-time case coverage support, training site personnel on investigational devices, or contributing to study protocols and publications, your work will directly support the development of technologies that improve patient outcomes. This is a largely travel-based position requiring routine on-site presence at clinical study locations throughout the East Coast. This role is ideal for someone who is detail-oriented, thrives in a dynamic environment, and is eager to grow their clinical research career at a company where their contributions truly matter. Duties and Responsibilities: The Clinical Research Associate I (CRA I) is responsible for assigned aspects of clinical research, in accordance with, applicable Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP). The CRA I will perform the following activities as directed: Provide real-time clinical research case coverage support, document case observations and provide summary reports as required. Ensure study procedures are conducted in accordance with the approved protocol, regulatory requirements, and Bright Uro guidelines. Contribute to clinical research development such as study protocols, monitoring plans, and other related clinical and regulatory documents. Assist in the management of investigational sites from identification and selection to study closure including engaging with the site to ensure preparedness for clinical research Advise and train site personnel in the proper study procedures and use of investigational devices, software applications, and/or study-specific tools as appropriate, including enforcing said training and troubleshooting device or procedural issues during cases. Serve as an additional point of contact between the site and Bright Uro. Assist in the planning and conduct of meetings (e.g., Investigator, Data and Safety Monitoring Board, Scientific Advisory Board), as well as the preparation of meeting minutes and reports. Assist or conduct site initiation visits (SIV) and interim monitoring visits (IMVs) such as preparing agendas, checklists, reports, and follow-up letters as appropriate. Assist in the formulation of instructional materials and training of clinicians, researchers, and other personnel. Provide continuous data review of source documents and case report forms (CRFs) (i.e., source data verification [SDV]) to ensure the timely, accurate, and complete collection and submission of study data. Ensure all required study documentation is completed at various stages of the clinical study (e.g., initiation, close-out) and maintain specific records of research activity for Bright Uro (e.g., Trial Master File [TMF]). Manage study supplies and ensure remaining study supplies are returned to Bright Uro. Monitor and track participant enrollment and study progress and attend study visits at investigational sites as appropriate. Monitor study progress to ensure compliance with the protocol requirements, FDA regulations, and Good Clinical Practice (GCP) to identify, address, and resolve issues and problems as they might occur at the investigational site. Contribute to scientific posters, publications, and other published materials. Perform other duties or tasks in clinical, research and development, regulatory, sales, marketing, and client services, or as directed by company leadership. Education and/or Work Experience Requirements: Must have a minimum of a Bachelor's Degree in a relevant science. Minimum of 2 years of relevant research experience. Experience may include work in a clinical laboratory, clinic, or pharmacy. Human Subjects Research and GCP in Medical Devices Certifications must be completed within 30 days of hire. Required Qualifications: Willingness and ability to travel a minimum of 80% of the time. Must reside near a major U.S. airport in the U.S. Eastern Time Zone. Excellent verbal and written communication skills, including the ability to effectively communicate with internal and external stakeholders. High level of personal and professional integrity, a strong work ethic, and the ability to work independently while managing and prioritizing multiple tasks simultaneously. Strong organizational skills with keen attention to detail and thorough documentation practices. Computer proficiency (Microsoft Office &ndash; Outlook, Word, Excel, and PowerPoint). Nice to Have: Prior startup or early-stage company experience.

Clinical Research Associate I (CRA I) - East Coast-Based

<div>Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description<div>
Join Us as a Clinical Research Associate (Level II) &ndash; Make an Impact at the Forefront of Innovation 
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. 
 
As part of our global team, you&rsquo;ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix. 
 
What You&rsquo;ll Do: 
<ul><li>Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.</li><li>Participates in investigator meetings as necessary. Identifies potential</li><li>investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.</li><li>Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.</li><li>Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).</li><li>Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.</li><li>Responds to company, client and applicable regulatory requirements/audits/inspections.</li><li>Maintains &amp; completes administrative tasks such as expense reports and timesheets in a timely manner.</li><li>Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.</li><li>Contributes to other project work and initiatives for process improvement, as required.</li></ul> 
Education and Experience Requirements: 
<ul><li>Bachelor's degree in a life sciences related fieldor a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.</li><li>Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship.</li><li>Valid driver's license where applicable.</li></ul>
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. 
 
Knowledge, Skills and Abilities: 
<ul><li>Proven clinical monitoring skills</li><li>Demonstrated understanding of medical/therapeutic area knowledge and medical terminology</li><li>Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents</li><li>Well-developed critical thinking skills, including but not limited to: critical mindset, in-depthinvestigation for appropriate root cause analysis and problem solving</li><li>Ability to manage Risk Based Monitoring concepts and processes</li><li>Good oral and written communication skills, with the ability to communicate effectively with medical personnel</li><li>Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers&rsquo; underlying issues</li><li>Good organizational and time management skills</li><li>Effective interpersonal skills</li><li>Attention to detail</li><li>Ability to remain flexibile and adaptable in a wide range of scenarios</li><li>Ability to work in a team or independently as required</li><li>Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software</li><li>Good English language and grammar skills</li><li>Good presentation skills</li></ul> 
Working Conditions and Environment: 
<ul><li>Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.</li><li>Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays.</li><li>Exposure to biological fluids with potential exposure to infectious organisms.</li><li>Personal protective equipment required such as protective eyewear, garments and gloves.</li><li>Exposure to fluctuating and/or extreme temperatures on rare occasions</li></ul></div></div>

CRA (Level II) - FSP Vaccines - Southeast

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

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