clinical research associate

Bristol Myers Squibb

<div><b>Working with Us</b><br>
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.<br>
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Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .<br>
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<b>Job Description</b><ul><li>
Conduct site qualification, initiation, routine monitoring and close-out visits across all trial phases in accordance with the Site Monitoring Plan, ensuring adherence to protocol, BMS Standard Operating Procedures (SOPs) and ICH GCP</li><li>
Maintain the ethical and scientific integrity of clinical trials by verifying data within electronic systems and paper records (as applicable) to ensure the accessibility, completeness and accuracy of data submitted by study sites</li><li>
Conduct site qualification, initiation, routine monitoring and close-out visits across all trial phases in accordance with the Site Monitoring Plan, ensuring adherence to protocol, BMS Standard Operating Procedures (SOPs) and ICH GCP</li><li>
Monitor site adherence to ICH GCP and local regulations, including compliance with the principles of ALCOA to maintain data integrity and reliability. Where required, provide training and support to site staff to uphold these standards and ensure patient safety. Participate in sponsor and/or Health Authority audits and inspections as applicable.</li><li>
Cultivate and sustain effective relationships with internal cross-functional teams and external partners, including vendors, clinical sites, and key stakeholders. Serve as the organization's representative for clinical trials at the site level.</li><li>
Motivate and influence sites to meet study objectives, including enrollment and retention goals.</li><li>
Communicate effectively, adapting to meet the needs of different stakeholders, utilizing the most appropriate communication style and method. Prepare and submit written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner</li><li>
Assess potential Investigators and their sites to ensure sufficient resources and capabilities to conduct clinical trials. May identify new potential Investigators and/or sites through ongoing collaborations with internal and external stakeholders during the site feasibility and selection process.</li><li>
Demonstrate understanding and proficiency working with targeted, centralized, remote and riskbased monitoring approaches</li><li>
Identify, assess, and prioritize risks at the site and study level and support sites in mitigating issues, including implementing mitigation strategies based on risk indicators</li><li>
Utilize strong analytical skills to evaluate site data and operational metrics, including ability to adjust monitoring strategies based on data trends and site performance</li><li>
Where applicable, perform Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor</li><li>
Accountable for the review, reconciliation, and oversight of study drug/IMP. May support study drug/IMP label translation needs as applicable.</li><li>
Involvement in Regulatory Compliance audit/inspection process, as needed. This includes the development and implementation of site corrective and preventive actions.</li><li>
In specific instances, may support start-up and submission related activities, including ICF reviews and collection of documents to/from site.</li><li>
Support provision of access to relevant BMS and vendor systems is available for clinical trial site personnel and ensures internal BMS systems are kept up to date for site monitoring activities.</li><li>
Support coordination of site activities related to database locks to ensure timelines are met as required locally.</li><li>
Perform timely site closure activities when all required protocol visits and follow-up are completed.</li></ul><b>
Qualifications &amp; Experience</b><br>
<br>
Degree/Certification/Licensure:
<br>
<br>
<ul><li>Bachelor's degree required, preferably within life sciences or equivalent</li></ul><br>
<ul><li>Valid driver's license (as locally required)</li></ul><br>
Experience:<br>
<br>
<ul><li>2-3 years of relevant clinical research experience, able to work independently, demonstrates proficiency in all aspects of the role</li></ul><br>
<ul><li>Relevant prior Pharma/Biotech Sponsor employment or experience as a clinical study coordinator</li></ul><br>
preferred<br>
<br>
<ul><li>Experience in the drug discovery/development process.</li></ul><br>
Competencies:<br>
<br>
<ul><li>Knowledge and understanding of clinical research processes, regulations and methodology</li></ul><br>
<ul><li>Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management</li></ul><br>
<ul><li>Working knowledge of ICH/GCP Guidelines and applicable local laws and regulations (that govern</li></ul><br>
clinical trials, with the ability to apply regulatory requirements to ensure compliance in clinical research activities (Analytical thinking/critical thinking skills. Capable of using technology to analyze<br>
<br>
diverse and complex data sets, identify issues, trends, and outliers to develop effective solutions<br>
<br>
(Demonstrate adaptability and a growth mindset by quickly learning and applying new technologies,<br>
<br>
embracing evolving methodologies, and remaining open to innovative ways of working in a dynamic<br>
<br>
environment<br>
<br>
<ul><li>Organization and time management skills</li></ul><br>
<ul><li>Ability to build, maintain and strengthen relationships even under pressure and/ or in difficult situations with internal and external stakeholders</li></ul><br>
<ul><li>Good verbal and written communication skills (both in English and local language)</li></ul><br>
<ul><li>Have a foundational level of disease understanding and awareness (how the protocol fits in current</li></ul><br>
landscape, standard of care, etc.)<br>
<br>
<ul><li>Proven ability to work independently with a high degree of autonomy, proactively managing tasks and</li></ul><br>
seeking opportunities for continuous learning<br>
<br>
<ul><li>Ability to manage multiple protocols, across multiple therapeutic areas, which may require travel,</li></ul><br>
based upon assigned site location and/or geographic territory<br>
<br>
<ul><li>Proficient in navigating and utilizing multiple clinical systems (e.g., CTMS, eTMF, RBQM dashboards) to</li></ul><br>
identify and resolve issues, support site performance, and ensure data integrity<br>
<br>
Software that must be used independently and without assistance (e.g., Microsoft Suite)<br>
<br>
<ul><li>Microsoft Suite</li></ul><br>
<ul><li>Clinical Trial Management Systems (CTMS)</li></ul><br>
<ul><li>Electronic Data Capture Systems (eDC)</li></ul><br>
<ul><li>Electronic Trial Master File (eTMF)</li></ul><br>
<ul><li>RBM tools and platforms (e.g., Veeva, Medidata, CluePoints).</li></ul><br>
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
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<b>Uniquely Interesting Work, Life-changing Careers</b><br>
With a single vision as inspiring as Transforming patients' lives through science&trade; , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.<br>
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<b>On-site Protocol</b><br>
<br>
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
<br>
<br>
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.
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BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
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BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.<br>
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If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
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Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.</div>

Clinical Research Associate

AtriCure, Inc.

AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure’s Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure’s AtriClip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure’s Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure’s cryoICE cryoSPHERE® probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.
<br><br>
We foster a culture of inclusion by embracing diverse experiences and individuals where everyone’s authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.
<br><br>
<b>Position Summary:</b><br>
The Clinical Research Associate II (CRA II) at AtriCure is a critical role within the Clinical Affairs department, responsible for site management and/or monitoring activities during clinical trial execution. This position involves working under moderate supervision to ensure compliance with study protocols and regulatory standards. The CRA II plays a pivotal role in maintaining the integrity of clinical data while adapting to the dynamic needs of different studies.
<br><br>
<b>Key Responsibilities:</b><b>Site Management:</b><br>
<ul>
<li>Coordinate the collection and review of essential documents from clinical investigation sites in collaboration with study team personnel.</li>
<li>Support site Qualification, Initiation, Interim and Close-Out training visits.</li>
<li>Assist with scheduling of required training sessions (e.g., EDC, Protocol, Device) and support site nomination and qualification processes.</li>
</ul>
<b>Site Communications:</b><br>
<ul>
<li>Serve as the main point of contact for site communications and inquiries.</li>
<li>Liaise with clinical study management, clinical development, site personnel, and CROs, escalating protocol or study related issues as necessary.</li>
</ul>
<b>Compliance:</b><br>
<ul>
<li>Ensure clinical study sites adhere to assigned study protocols and regulatory standards, notifying study management of any concerns.</li>
</ul>
<b>Data Management:</b><br>
<ul>
<li>Review and analyze data for accuracy and completeness.</li>
<li>Manage the creation, resolution, and tracking of data queries.</li>
</ul>
<b>Monitoring:</b><br>
<ul>
<li>Conduct site monitoring visits (qualification, initiation, interim, and close-out) to ensure adherence to study procedures and regulatory requirements.</li>
</ul>
<b>Safety:</b><br>
<ul>
<li>Process product complaints and adverse events as reported, collaborating with safety specialists to gather necessary materials for CEC meetings.</li>
</ul>
<b>Study Management:</b><br>
<ul>
<li>Assist in the development of study-related materials, including patient recruitment materials and newsletters.</li>
<li>Facilitate ordering of clinical study devices, including verification and tracking of the devices to ensure proper receipt and storage at study sites</li>
<li>Coordinate activities with study-specific committees, vendor services, and core labs.</li>
</ul>
<b>Other Duties:</b><br>
<ul>
<li>Ensure appropriate translations for study documents.</li>
<li>Contribute to process improvement initiatives and department activities.</li>
</ul>
<b>Leadership & Development:</b><br>
<ul>
<li>Focus on self-development with opportunities to mentor entry-level professionals.</li>
<li>Engage in continuous learning and professional development in clinical research areas.</li>
</ul>
<b>Qualifications and Experience:</b><br>
<ul>
<li>Bachelor’s degree with a minimum of 2 years of clinical research experience.</li>
<li>Strong organizational and communication skills with an ability to work effectively in a team.</li>
<li>Proficiency in Microsoft Office Suite and familiarity with clinical data management systems.</li>
<li>Willingness to travel between 10-75% of the time.</li>
</ul>
#LI-KN1
<br><br>
AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 20 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria. To see a complete list of our benefits, please visit our careers website: https://www.atricure.com/careers-atricure/benefits. AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here https://www.e-verify.gov/ AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).

Clinical Research Associate II

ProPharma Group

<div><div>For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality &amp; compliance, pharmacovigilance, medical information, and R&amp;D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners&rsquo; most high-profile drug and device programs.</div><div></div><div>
The Clinical Research Associate position is responsible for clinical monitoring<br>
for assigned protocols and investigational sites as well as ensuring that<br>
studies are conducted and documented in accordance with the study<br>
protocol, standard operating procedures, Good Clinical Practices (GCP) and<br>
other applicable regulatory requirements.</div><div></div><div>
Essential Functions</div><ul><li><div>
Responsible for conduct of all types of monitoring, and co-monitoring visits and associated monitoring activities for assigned clinical sites both in person, and remote. This includes evaluation, site initiation, interim and close out monitoring visits. Responsible for monitoring report writing and completion within required SOP and local regulatory parameters.</div></li><li><div>
Supports development of study specific documentation related to monitoring activities as assigned. This includes but is not limited to monitoring trackers, clinical monitoring guidelines, clinical monitoring plan, source document templates, site tools, and worksheets, etc. Responsible for site personnel management and training on the protocol requirements, proper source documentation procedures compliance, and case report completion requirements.</div></li><li><div>
Responsible for source document and case report forms review for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues.</div></li><li><div>
Managing, preparing, sending, tracking, and returning investigational supplies as assigned. Includes monitoring and documenting investigational supplies dispensing, inventory, and reconciliation.</div></li><li><div>
Monitoring assigned clinical trials and clinical sites by reviewing and reporting site enrollment, and termination updates, monitoring visits, protocol deviations, serious adverse events, laboratory abnormalities and any other activity at the site that contributes to proper conduct of the clinical trial per protocol, and regulatory requirements.</div></li><li><div>
Responsible for review and oversight of regulatory documentations for accuracy, completeness, and supporting assigned clinical sites with any regulatory concerns as appropriate.</div></li><li><div>
Responsible for consistent and timely communication with assigned clinical sites, investigators, site personnel, client personnel, and any other cross functional team member involved in the assigned clinicaltrials to address any study needs related to the monitoring and site management activities as assigned.</div></li><li><div>
Participates in meetings and conference calls with internal project teams, Sponsor teams, and any external partners working on execution of the assigned clinical trial.</div></li><li><div>
Other duties as assigned.</div></li></ul><div></div><div>
Necessary Skills and Abilities</div><ul><li><div>
Targeting those on the west coast with IVD therapeutic experience.</div></li><li><div>
Excellent verbal, written communication skills and interpersonal and presentation skills are required.</div></li><li><div>
Excellent computer skills with experience using Microsoft Office (Outlook, Word, Excel, and Power Point) applications to prepare charts, tables, forms, reports, and presentations required.</div></li><li><div>
Electronic data capture (EDC), CTMS, IVRS, and eTMF experience required.</div></li><li><div>
Knowledge of applicable regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.</div></li><li><div>
Must be able to prioritize tasks, plan proactively, and accomplish goals using well-defined instructions and procedures with minimal supervision.</div></li><li><div>
Must be able to offer solutions when obstacles are identified and train as necessary to achieve project goals.</div></li><li><div>
Must have a general understanding of routine project goals from an organizational perspective.</div></li><li><div>
Strong organizational skills and attention to details required. Ability to prioritize and plan workload is essential.</div></li></ul><div></div><div>
Educational Requirements</div><ul><li><div>
 Bachelor's degree or equivalent combination of education and experience.</div></li></ul><div></div><div>
Experience Requirements</div><ul><li><div>
4 years of experience as a Clinical Research Associate.</div></li></ul><div></div><div>
#LI-JH1</div><div></div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div>
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.</div><div></div><div>
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***</div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div>

Clinical Research Associate (West Coast)

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.
 <br/>
 <br/>
 <strong>
  Background &amp; Qualifications
  <br/>
  <br/>
 </strong>
 <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.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Job Description
  <br/>
  <br/>
 </strong>
 <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.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Why AstraZeneca?
  <br/>
  <br/>
 </strong>
 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.
 <br/>
 <br/>
 <strong>
  Where can I find out more?
  <br/>
  <br/>
 </strong>
 Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
 <br/>
 <br/>
 Follow AstraZeneca on Instagram https://www.instagram.com/astrazenecaturkiyekariyer/
 <br/>
 <br/>
 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)

Parexel

<div><p><b>Key Accountabilities:</b></p><p></p><p><b><br>
Site Management Responsibilities</b></p><ul><li><p>
Contributes to the selection of potential investigators.</p></li><li><p>
In some countries, as required, SrCRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.</p></li><li><p>
Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.</p></li><li><p>
Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are always inspection ready.</p></li><li><p>
Actively participates in Local Study Team (LST) meetings.</p></li><li><p>
Contributes to National Investigators meetings, as applicable.</p></li><li><p>
Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST.</p></li><li><p>
Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.</p></li><li><p>
Updates CTMS and other systems with data from study sites as per required timelines.</p></li><li><p>
Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.</p></li><li><p>
Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visits.</p></li><li><p>
Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.</p></li><li><p>
Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.</p></li><li><p>
Ensures data query resolution in a timely manner.</p></li><li><p>
Works with data management to ensure robust quality of the collected study data.</p></li><li><p>
Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.</p></li><li><p>
Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP.</p></li><li><p>
Follows up on outstanding actions with study sites to ensure resolution in a timely manner.</p></li><li><p>
Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required.</p></li><li><p>
Assists site in maintaining inspection ready ISF.</p></li><li><p>
Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD).</p></li><li><p>
Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate.</p></li><li><p>
 Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF.</p></li><li><p>
Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.</p></li><li><p>
Collaborates with local Medical Scientific Liaisons (MSLs) as directed by LSAD or line manager</p></li></ul><p></p><p><b><br>
Compliance with Sponsor Standards</b></p><ul><li><p>
Ensures compliance with the Client&rsquo;s Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment).</p></li><li><p>
Ensures compliance with local, national, and regional legislation, as applicable.</p></li><li><p>
Completes timesheets accurately as required</p></li></ul><p></p><p><b><br>
Compliance with Parexel Standards</b></p><ul><li><p>
Complies with required training curriculum.</p></li><li><p>
Completes timesheets accurately as required.</p></li><li><p>
Submits expense reports as required.</p></li><li><p>
Updates CV as required.</p></li><li><p>
Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements.</p></li></ul><p><b>
Skills (Essential):</b></p><ul><li><p>
Excellent attention to detail.</p></li><li><p>
Good written and verbal communication skills.</p></li><li><p>
Good collaboration and interpersonal skills.</p></li><li><p>
Good negotiation skills.</p></li><li><p>
Proficient in written and spoken English language required.</p></li><li><p>
Fluency in local language(s) required.</p></li></ul><p><b>
Skills (Desirable):</b></p><ul><li><p>
Ability to work in an environment of remote collaborators. Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.</p></li><li><p>
Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.</p></li><li><p>
Good analytical and problem-solving skills.</p></li><li><p>
Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.</p></li><li><p>
Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.</p></li><li><p>
Team oriented and flexible; ability to respond quickly to shifting demands and opportunities Knowledge and Experience (Essential):</p></li><li><p>
Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. &bull; Good knowledge of relevant local regulations.</p></li><li><p>
Good medical knowledge and ability to learn relevant Client Therapeutic Areas.</p></li><li><p>
Basic understanding of the drug development process.</p></li><li><p>
Good understanding of Clinical Study Management including monitoring, study drug handling and data management.</p></li></ul><p></p><p><b><br>
Knowledge and Experience (Desirable):</b></p><ul><li><p>
Familiar with risk-based monitoring approach including remote monitoring.</p></li><li><p>
Good cultural awareness.</p></li></ul><p></p><p><b><br>
Education:</b></p><ul><li><p>
Bachelor&rsquo;s degree in related discipline, preferably in life science, (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.</p></li></ul><p><b>
Other:</b></p><ul><li><p>
Ability to travel nationally/internationally as required.</p></li><li><p>
Valid driving license per country requirements, as applicable</p></li></ul><br>
<p></p>
#LI-REMOTE</div>

Senior Clinical Research Associate - FSP

Thermo Fisher Scientific

<div><p><b>Work Schedule</b></p>
Standard (Mon-Fri)<p></p><p><b>
Environmental Conditions</b></p>
Office<p></p><p><b>
Job Description</b></p><p></p><p>
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.</p><p></p><h2 class="jobSectionHeader"><b>
Discover Impactful Work:</b></h2><p></p><p>
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.</p><p></p><h2 class="jobSectionHeader"><b>
A day in the Life:</b></h2><p></p><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><p></p><h2 class="jobSectionHeader"><b>
Keys to Success:</b></h2><p></p><h2 class="jobSectionHeader"><b>
Education</b></h2><p></p><ul><li>
University degree in a life-sciences field</li></ul><p></p><h2 class="jobSectionHeader"><b>
Experience</b></h2><p></p><ul><li>
Experience of independent, on-site monitoring experience in a Pharmaceutical or Clinical Research Organisation</li></ul><p></p><h2 class="jobSectionHeader"><b>
Knowledge, Skills, Abilities</b></h2><p></p><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><p></p>

Clinical Research Associate (CRA) - Client-dedicated

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