clinical trial monitor

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>
This is a fully remote role supporting one of our key customers. We welcome applicants from all locations within the US.</p><p>
Must be legally authorized to work in the United States without sponsorship.</p><p>
Must be able to pass a comprehensive background check, which includes a drug screening.</p><p></p><p>
Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission &ndash; to enable our customers to make the world healthier, safer, and cleaner.</p><p>
Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.</p><p></p><p>
The Research Scientist acts as the sponsor representative/study monitor for one or more studies and supports the bioanalytical study phases of clinical trials.</p><p></p><p><b>
Key responsibilities:</b></p><ul><li>
Reviews trial related documentation with a link to the GxP vendor (i.e., CTP, SAP, TLF&rsquo;s, CSR, Lab manual)</li><li>
Ensures the bioanalytical vendor receives copies of trial related documentation and relevant amendments (e.g., clinical trial protocol)</li><li>
Reviews and approves study plans of bioanalytical phases of clinical trials</li><li>
Reviews and approves (if applicable) bioanalytical reports</li><li>
Oversees planned and unplanned changes to study plan and vendor procedures are documented according to vendor procedures (e.g., in amendments and deviations) and are shared with the sponsor as stipulated in the quality agreement or communication plan</li><li>
Ensures that the Clinical Trial Team is adequately informed of the project status and that relevant information (e.g., end-of-study timelines and data delivery requirements) from the Clinical Trial Team is conveyed to the project manager and bioanalytical vendor</li><li>
Escalates issues related to timelines, budget or communication to the appropriate stakeholders</li><li>
Manages oversight documentation in eTMF</li><li>
Contributes to interactions with regulatory agencies (if applicable)</li></ul><p></p><p><b>
Education and Experience:</b></p><ul><li><ul><li>PhD in Immunology or Molecular Biology and previous experience in the field of life sciences that provides the knowledge, skills, and abilities to perform the job comparable to 3+ years</li></ul></li><li>
OR</li><li>
Master&rsquo;s Degree and previous experience in the field of life sciences that provides the knowledge, skills, and abilities to perform the job comparable to 6+ years</li></ul><p></p><p>
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.</p><p></p><p><b>
Knowledge, Skills and Abilities:</b></p><ul><li>
Experience in managing outsourced activities at external vendors required</li><li>
Strong knowledge of bioanalytical techniques specifically in biologics and antibodies assays required &middot; Experience performing PK and ADA assays required</li><li>
Experience in analyzing human samples in support of clinical trials required</li><li>
Strong understanding of GCP/GCLP guidelines and other current global regulations required</li><li>
Experience with submission documentation and regulatory interactions</li><li>
Experience with clinical immunogenicity data interpretation, writing and reviewing the Integrated Summary of Immunogenicity (ISI) and clinical study report</li><li>
Experience drafting and reviewing bioanalytical modules (2.7.1, 2.7.2) and immunogenicity sections in regulatory documents either independently or collaboration with a medical writer</li></ul><p></p><p>
Working Environment:</p><p>
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:</p><ul><li>
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.</li><li>
Able to work upright and stationary for typical working hours.</li><li>
Ability to use and learn standard office equipment and technology with proficiency.</li><li>
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.</li></ul></div><p></p>

Research Scientist PI - Bioanalytical

ICON plc

<div>Senior Clinical Research Associate<div></div><div>
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development</div><div></div><div>
We are currently seeking a Senior Clinical Research Associate (CRA) to join our diverse and dynamic team. As a Senior CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle.</div><div></div><div>
What You Will Be Doing:</div><ul><li>
Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.</li><li>
Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.</li><li>
Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.</li><li>
Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.</li><li>
Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.</li></ul><div>
Your Profile:</div><ul><li>
Advanced degree in a relevant field such as life sciences, nursing, or medicine.</li><li>
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.</li><li>
Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills.</li><li>
Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.</li><li>
Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.</li><li><div>
Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver&rsquo;s license</div></li></ul><div></div><div>
What ICON can offer you:</div><div></div><div><div><div><div><div>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.</div><div></div><div>
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.</div><div></div><div>
Our benefits examples include:</div><ul><li><div>
Various annual leave entitlements</div></li><li><div>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</div></li><li><div>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</div></li><li><div>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</div></li><li><div>
Life assurance</div></li><li><div>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</div></li></ul></div></div></div></div><div></div><div>
Visit our <div>careers site</div> to read more about the benefits ICON offers.</div><div></div><div>
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.</div><div></div><div><div><div><div><div>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know</div><div></div><div><div>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</div></div></div></div></div></div></div><div></div>

Senior CRA

IQVIA

<div><div><div>New Cairo, Egypt | Full time | Hybrid | R1520390</div></div><p></p><div><div><b><br>
Job Overview</b><br>
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.</div><div><b>
Essential Functions</b><br>
<ul><li>Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines</li><li>Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.</li><li>Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.</li><li>Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.</li><li>Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.</li><li>Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.</li><li>Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.</li><li>Collaborate and liaise with study team members for project execution support as appropriate.</li><li>If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.</li><li>If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.</li></ul></div><div><b>
Qualifications</b><br>
<ul><li>High School Diploma or equivalent Degree in scientific discipline or health care preferred.</li><li>Requires at least 1 year of on-site monitoring experience.</li><li>Equivalent combination of education, training and experience may be accepted in lieu of degree.</li><li>Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).</li><li>Good therapeutic and protocol knowledge as provided in company training.</li><li>Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).</li><li>Written and verbal communication skills including good command of Arabic and English language.</li><li>Organizational and problem-solving skills.</li><li>Effective time and financial management skills.</li><li>Ability to establish and maintain effective working relationships with coworkers, managers, and clients.</li></ul></div><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></div><div></div>

Clinical Research Associate Sponsor-dedicated

<div>
 <strong>
  Job Overview
  <br/>
  <br/>
 </strong>
 Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
 <br/>
 <br/>
 <strong>
  Essential Functions
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  </li>
  <li>
   Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
  </li>
  <li>
   Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
  </li>
  <li>
   Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
  </li>
  <li>
   Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
  </li>
  <li>
   Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
  </li>
  <li>
   Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
  </li>
  <li>
   Collaborate and liaise with study team members for project execution support as appropriate.
  </li>
  <li>
   If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
  </li>
  <li>
   If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Qualifications
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   High School Diploma or equivalent Degree in scientific discipline or health care preferred.
  </li>
  <li>
   Requires at least 1 year of on-site monitoring experience.
  </li>
  <li>
   Equivalent combination of education, training and experience may be accepted in lieu of degree.
  </li>
  <li>
   Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
  </li>
  <li>
   Good therapeutic and protocol knowledge as provided in company training.
  </li>
  <li>
   Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
  </li>
  <li>
   Written and verbal communication skills including good command of Arabic and English language.
  </li>
  <li>
   Organizational and problem-solving skills.
  </li>
  <li>
   Effective time and financial management skills.
  </li>
  <li>
   Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
   <br/>
   <br/>
  </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
</div>


<div><p><b>Job Overview</b><br>
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.</p><p></p><div><b>
Essential Functions</b><br>
<ul><li>Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.</li><li>Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.</li><li>Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.</li><li>Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.</li><li>Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.</li><li>Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.</li><li>Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.</li><li>Collaborate and liaise with study team members for project execution support as appropriate.</li><li>If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.</li><li>If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.</li></ul></div><p></p><div><b>
Qualifications</b><br>
<ul><li>High School Diploma or equivalent Degree in scientific discipline or health care preferred.</li><li>Requires at least 2 years of year of on-site monitoring experience.</li><li>Equivalent combination of education, training and experience may be accepted in lieu of degree.</li><li>Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.</li><li>i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.</li><li>Good therapeutic and protocol knowledge as provided in company training.</li><li>Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).</li><li>Written and verbal communication skills including good command of Arabic and English language.</li><li>Organizational and problem-solving skills.</li><li>Effective time and financial management skills.</li><li>Ability to establish and maintain effective working relationships with coworkers, managers, and clients.</li></ul></div><p></p><p>
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</p></div>

Experienced Clinical Research Associate Sponsor-dedicated

BeOne Medicines

<div><div>BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.</div><div></div><div>
General Description:</div><div></div><ul><li>
The CRA executes clinical monitoring activities at clinical trial sites and monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs.</li><li>
Performs monitoring activities related to selection, initiation, conduct (recruitment, quality data collection) and timely completion of oncology/hematology clinical trials within the assigned region.</li><li>
The CRA is responsible for collaborating closely with the Regional Clinical Operations Manager to ensure study timelines are adhered to and required quality standards are maintained.</li><li>
Identify gaps and areas for improvement and propose CAPA.</li><li>
Supports start-up and provides local expertise.</li><li>
SSU experience is considered a plus</li></ul><div></div><div>
CRA activities</div><ul><li><div>
Perform feasibility, site identification, selection and evaluation, supporting initial list of sites and recruitment targets</div></li><li><div>
Provides protocol and related study training to assigned sites.</div></li><li><div>
Conducts monitoring (pre-study, initiation, routine monitoring and closeout visits per monitoring plan and applicable SOPs</div></li><li><div>
Conducts co-monitoring visits, if required</div></li><li><div>
Completes monitoring visit reports in accordance with ICH-GCP, BeOne Medicines standards and SOP</div></li><li><div>
Manages sites and site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.</div></li><li><div>
Establish regular lines of communication with sites and reports site progress, issues and proposed action to Clinical Operations</div></li><li><div>
Ensure inspection readiness of the study and sites</div></li><li><div>
Collaborates with Regional Clinical Operations Manager and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.)</div></li><li><div>
Attends disease indication project specific training and general CRA training as required</div></li><li><div>
Facilitate Study Oversight Visits (SOVs), site audits and/or inspections, as required</div></li><li><div>
Evaluates the quality and integrity of site practices &ndash; escalating quality and/or GCP issues with Investigators and internal team as appropriate.</div></li><li><div>
Anticipate and identify site issues; propose corrective and preventative actions; identify gaps and utilize opportunities. Constantly strive for operating excellence, question status-quo and promote innovation.</div></li></ul><div></div><div>
Education Required:</div><ul><li><div>
BS in a relevant scientific discipline and minimum of 2 years of monitoring experience.</div></li><li><div>
Experience in oncology global trials preferred</div></li></ul><div></div><div>
Other Qualifications:</div><ul><li><div>
Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines</div></li><li><div>
At least 2 years of (CRA) monitoring experience in the pharmaceutical or CRO industry</div></li><li><div>
Experience in oncology/hematology trials preferred</div></li><li><div>
Excellent communication and interpersonal skills</div></li><li><div>
Excellent organizational skills and ability to prioritize and multi-task</div></li><li><div>
Fluent in English &amp; Turkish (writing and speaking)</div></li></ul><div></div><div>
Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook</div><div></div><div>
Travel: up to 60%</div><div></div><div>
Global Competencies</div><div>
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.</div><ul><li>
Fosters Teamwork</li><li>
Provides and Solicits Honest and Actionable Feedback</li><li>
Self-Awareness</li><li>
Acts Inclusively</li><li>
Demonstrates Initiative</li><li>
Entrepreneurial Mindset</li><li>
Continuous Learning</li><li>
Embraces Change</li><li>
Results-Oriented</li><li>
Analytical Thinking/Data Analysis</li><li>
Financial Excellence</li><li>
Communicates with Clarity</li></ul><div></div><div>
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.</div></div><div></div>

Clinical Research Associate

Syneos Health

<div><p><b>Description</b>
</p>Sr CRA II - FSP - Turkey - Homebased<p></p><p>
Syneos Health&reg; is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.</p><p>
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.</p><p></p><p>
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you&rsquo;ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.</p><p></p><p>
Discover what our 29,000 employees, across 110 countries already know:</p><p></p><p><b>
WORK HERE MATTERS EVERYWHERE</b></p><p></p><p>
Why Syneos Health</p><ul><li>
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.</li><li>
We are committed to our Total Self culture &ndash; where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.</li><li>
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives &ndash; we&rsquo;re able to create a place where everyone feels like they belong.</li></ul><p></p><p><b>
Job Responsibilities</b></p><p></p><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<br>
Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines<br>
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:<br>
Site support throughout the study lifecycle from site identification through close-out. Knowledge of local requirements for real world late phase study designs<br>
Chart abstraction activities and data collection<br>
As required, collaborate and build relationship with Sponsor and other affiliates, medical science liaisons and local country staff<br>
The SMA II may be requested to train junior staff<br>
Identify and communicate out of scope activities to Lead CRA/Project Manager<br>
Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations.<br>
Identify operational efficiencies and process improvements<br>
Develop study and country level informed consent forms<br>
Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared<br>
Participate in bid defense meetings<br>
Provide input into Requests for Proposals (RFPs), scope and budgeting. Develop site management strategy.<br>
Participate in Case Report Form design and edit check development.</li></ul><p></p><p>
Qualifications:</p><p></p><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><p></p><p><b>
Get to know Syneos Health</b></p><p><br>
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.</p><p></p><p>
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.</p><p></p><p>
http://www.syneoshealth.com</p><p></p><p><b>
Additional Information</b></p><p><br>
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.</p><p><b>
Summary</b>
</p>Roles within Clinical Monitoring/CRA job family are responsible for monitoring during clinical research studies to ensure that the trials are being conducted in accordance with widely accepted clinical practices. This includes conducting on-site and remote monitoring, developing tools, procedures, and processes to ensure quality monitoring.Impact and ContributionIndividual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Individual contributor with developing subject matter expertise and responsibility for processes. In-depth knowledge and skills within a professional discipline, understanding the impact of work on related areas. May be responsible for entire projects or processes within area of responsibility.</div>

Sr CRA II - FSP - Turkey - Homebased

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