clinical trial monitor

Thermo Fisher Scientific

<div>Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
This is a fully remote role supporting one of our key customers. We welcome applicants from all locations within the US.
Must be legally authorized to work in the United States without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.
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.
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.
The Research Scientist acts as the sponsor representative/study monitor for one or more studies and supports the bioanalytical study phases of clinical trials.
Key responsibilities:<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>
Education and Experience:<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 4+ 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><li>
OR</li><li>
Bachelor's Degree and previous experience in the field of life sciences that provides the knowledge, skills, and abilities to perform the job comparable to 8+ years</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>
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>
Working Environment:
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:<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>

Research Scientist PI - Bioanalytical

<div>Work Schedule
Environmental Conditions
Job Description
Join Us as a Clinical Research Associate (Level II) &ndash; IVD and Clinical &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. The IVD Clinical Research Associate (CRA) is responsible for monitoring clinical trial testing sites to ensure compliance with Clinical Performance Study Protocol (CPSP), protocol, ICH-GCP guidelines, SOPs, and applicable regulatory requirements. The CRA serves as the primary liaison between the clinical lead and investigational testing sites and ensures the integrity, quality, and timely delivery of IVD testing data.
As a Clinical Research Associate (Level II), you'll also 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>Perform testing site initiation, monitoring visits and close-out, in accordance with the Monitoring Plan.</li><li>Ensure CPSP/protocol adherence and IVD safety and quality.</li><li>Assess adequacy of site resources, laboratory equipment, and infrastructure</li><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 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>Train testing site staff on CPSP, protocol, EDC, safety reporting, testing devices and study procedures.</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 Microbiology or 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 2 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-depth `investigation 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 flexible 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>Fluency in Arabic and 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><div><div><div><ul><li>Please submit your CV in English
</li></ul></div></div></div></div></div><div><div>Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.</div></div></div>

CRA II - IVD and Clinical

<div>
 
 Work Schedule
 
 
 
 Standard (Mon-Fri)
 
 
 
 Environmental Conditions
 
 
 
 Office
 
 
 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

Alira Health

<div>Are you being referred to one of our roles by a connection in Alira Health? If so, please apply using the referral link emailed to you.
Join our global team dedicated to innovation and initiative, where physical walls and different time zones don&rsquo;t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.
Job Description Summary
The Lead CRA is an important member of the Alira Health Clinical team. The Lead CRA provides oversight, leadership, and guidance in the management and execution of clinical trial monitoring to ensure compliance and quality. Lead CRAs work closely with the Director of Clinical Monitoring, CRAs, CTCs and Clinical Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues.
Job Description<h2 class="jobSectionHeader">
THE LEAD CLINICAL RESEARCH ASSOCIATE ROLE</h2><h3 class="jobSectionHeader">
ESSENTIAL JOB FUNCTIONS*</h3><ul><li>
Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work, Alira Health SOPs and regulatory requirements, i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines.</li><li>
May perform Central Monitoring activities, or act as the primary liaison between site and Central Monitor.</li><li>
Collaborate with cross-functional teams and CRAs to maintain high standards of clinical trial conduct.</li><li>
Exhibits meticulous care in upholding the privacy of all subjects/participants.</li><li>
Escalates quality issues or trends appropriately per the escalation pathway.</li><li>
Conducts investigational product (IP) inventory and accountability, while evaluating storage conditions and access protocols. Confirms IP has been dispensed and administered to participants in compliance with the study protocol. Leverages expertise in GCP, local regulations and Alira Health procedures to ensure IP is properly labeled, relabeled, transported, released, returned or destroyed.</li><li>
Reviews the Investigator Site File (ISF) for audit readiness including accuracy and completeness. Reconciles the ISF with the Trial Master File (TMF), ensuring filing of essential documents in accordance with local guidelines and regulations.</li><li>
Performs quality checks on regulatory documents per ALCOA+ principles, collecting copies for TMF filing. Supports audit readiness by submitting documents to the TMF, utilizing the filing index and medidata as necessary.</li><li>
Verification and review of safety events (AE/SAE/UADE/AESI, etc) including reconciliation of concomitant medications and medical history to confirm accurate reporting in accordance with the protocol, local regulations and regulations.</li><li>
Prepares accurate monitoring visit reports and communication logs in alignment with Alira Health SOPs and the Clinical Monitoring Plan timelines. Reports detail site-specific concerns, follow-up tasks, corrective actions, protocol deviations and violations, enrollment progress and safety events collected.</li><li>
Participates in internal, client/sponsor, scientific, and other meetings as required.</li><li>
Works with other CRAs to maintain consistency and promote a collaborative team atmosphere.</li><li>
Assists in set up/collection of site-specific ethics documents and site contract negotiation.</li><li>
Provides monthly billing information to finance team as required.</li><li>
For monitoring stand-alone projects, manages study budget and acts as referent for the sponsor.</li><li>
Provides monthly billing information to the finance and project management team, as needed.</li><li>
Performs CRA training and mentoring to more junior level CRAs.</li><li>
May co-monitor and perform Evaluation Visits for more junior level CRAs.</li><li>
Provides guidance, oversight, and feedback to the study team to ensure adherence to project scope, study plans, timelines, and budget requirements.</li><li>
Oversees Clinical Research Associates (CRAs) to ensure monitoring visits are conducted within the timelines specific in the Clinical Monitoring Plan or adjusted as necessary to align with the project requirements. Monitors site and CRA performance to maintain SDV rates within study goal range, directing CRAs to perform additional visits when thresholds are not met.</li><li>
Oversees CRAs in the execution of ongoing site management activities, including reviewing Electronic Data Capture (EDC) queries, resolving follow-up items and responding to site staff inquiries in a timely manner.</li><li>
Can serve as a line manager with direct reports, with accountability for CRA annual performance reviews, continued career progression, Key Performance Indicators (KPIs) and study/site assignments.</li><li>
Ensure CRAs are working with sites to drive, track and report on subject recruitment in line with project needs and expectations.</li><li>
Provide protocol and study related training to assigned CRA and establish regular lines of communication to manage ongoing project expectations and issues.</li><li>
Evaluate the quality and integrity of CRA performance through monitoring visit report review. Review will ensure evidence of adequate CRA oversight and site management per the Clinical Monitoring Plan (CMP), Alira Health SOPs and ICH GCP. Specifically, adequate oversight of IP and accountability, routine review of ISF and audit readiness, clear and adequate reporting of protocol deviations, ensuring resolve of follow-up items in a timely manner and study compliance by the site staff and PI. Trends are shared with the Project Manager and escalated to the Sponsor as necessary.</li><li>
Evaluate the quality and integrity of CRA performance through metric tracking. Specifically, tracking EDC query resolution and follow-up issue duration. Trends are shared with the Project Manager and escalated to the Sponsor as necessary.</li><li>
Maintains oversight and accountability of monitoring visit reports, ensuring CRAs submit the draft, and the report is finalized within the Alira Health SOP and CMP timelines. Responsible for tracking study specific metrics, sharing with the Project Manager and escalating to the Director of Clinical Monitoring as needed.</li><li>
Consistently reviews monitoring visit reports within the Alira Health SOP and CMP timelines.</li><li>
Works closely with Project Managers, CRAs and Data Management to resolve CRF queries on discrepant data.</li><li>
Collaborates with development, maintenance and training of the Clinical Trial Management System (CTMS) and Trial Master File (TMF).</li><li>
Prepares for, attends and presents during Investigator Meetings.</li><li>
Conducts project specific CRA meetings and trainings.</li><li>
May be mentored and assigned Project Management, or other operational tasks, under the supervision of an experienced team member.</li><li>
Assists in resourcing planning for upcoming and ongoing clinical trials.</li><li>
Can support hiring potential new employees.</li><li>
Can be responsible for CRA new hire training and onboarding.</li><li>
Can conduct review of CRA timesheet reporting.</li><li>
May participate and present in bid defense meetings.</li><li>
May participate in audits and associated meetings, including preparation at study sites as needed.</li><li>
Collaborates with study team members for project execution and performs additional duties and tasks as assigned.</li></ul><h2 class="jobSectionHeader">
PREPARATION, KNOWLEDGE, SKILLS &amp; ABILITIES</h2><ul><li>
Dedicated and results oriented with a bachelor&rsquo;s degree in a relevant field (sciences, nursing, medical preferred).</li><li>
Preferred 7+ years&rsquo; experience in the clinical research or health industry fields. Clinical monitoring experience required in the pharmaceutical, biotech, medtech or CRO industries. People and study management experience required.</li><li>
Expertise in data management, site management and monitoring, including proficiency in clinical trial software and tools.</li><li>
Committed to quality with a proven track record of being thorough and detail-oriented in ensuring protocol adherence and data integrity.</li><li>
Excels in organizational and time management skills, enabling effective multitasking in fast-paced environments while managing priorities, organizing time efficiently, and solving complex problems.</li><li>
Possess strong analytical, negotiation, meeting management, cross-functional team collaboration, and leadership skills to drive successful trial outcomes.</li><li>
Willing and able to travel up to 85% to support site visits and project needs.</li><li>
Professional, trustworthy, and disciplined self-starter who thrives in collaborative team settings, fostering a positive and productive atmosphere.</li><li>
In-depth knowledge of ICH GCP and ISO 14155 guidelines, along with local regulatory requirements.</li><li>
Skilled at establishing and maintaining positive relationships with sponsors, investigative sites, and cross-functional project teams to facilitate seamless communication and achieve study milestones.</li><li>
Experience in people and study management.</li><li>
Strong command of English, and the local language as necessary, both written and verbal.</li></ul><h2 class="jobSectionHeader">
WORKING CONDITIONS/PHYSICAL DEMANDS</h2>
Normal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use. Occasional lifting of weight up to 30 lbs.
Compensation: $130,000 - 155,000 commensurate with experience
Languages
English
Education
Bachelor of Science (BS): Biology, Bachelor of Science (BS): Biotechnology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): Pharmacy
Contract Type
Regular</div>

Lead Clinical Research Associate

<div>Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
At Thermo Fisher Scientific, you&rsquo;ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on &ndash; now and in the future.
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 execute high-quality, cost-efficient clinical studies.
Our Clinical Operations team is searching for an experienced CRA (all levels)!<h2 class="jobSectionHeader">
Position Overview:</h2>
Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring 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. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.<h2 class="jobSectionHeader">
Essential Functions:</h2><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. May help to identify potential 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 team as required. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System).</li><li>
Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections.</li><li>
Maintains and 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. Contributes to other project work and initiatives for process improvement, as required.</li></ul><h1 class="jobSectionHeader">
Keys to Success:</h1><h2 class="jobSectionHeader">
Education and Experience:</h2><ul><li>
Bachelor's degree in a life science-related field</li><li>
Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years independent on-site monitoring experience as clinical research monitor) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered.</li><li>
Proven understanding of ICH-GCP, EU and FDA requirements</li><li>
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology</li><li>
Outstanding communication, collaboration, organisational and time management skills</li><li>
Fluent in English and Turkish</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.<h2 class="jobSectionHeader">
Knowledge, Skills, Abilities</h2><ul><li>
Basic medical/therapeutic area knowledge and understanding of medical terminology</li><li>
Ability to attain and maintain a working knowledge of ICH GCPs and applicable regulations and procedural documents</li><li>
Good oral and written communication skills, with the ability to communicate effectively with medical personnel</li><li>
Good interpersonal skills</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>
Ability to remain flexible and adaptable in a wide range of scenarios</li><li>
Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving</li><li>
Ability to manage Risk Based Monitoring concepts and processes</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>
Must be based in T&uuml;rkiye.</li></ul><h2 class="jobSectionHeader">
Why Join Us?</h2>
We hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore you will benefit from an award-winning learning and development programme, ensuring you reach your potential.<h2 class="jobSectionHeader">
What We Offer:</h2>
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD&reg; clinical research services truly value a work-life balance. We&rsquo;ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.</div>

Clinical Research Associate (CRA) - All Levels

Everest Clinical Research

<div>Everest Clinical Research (&ldquo;Everest&rdquo;) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest&rsquo;s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.

Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients&rsquo; needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength&hellip;that&rsquo;s us&hellip;that&rsquo;s Everest.

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as a Senior Clinical Research Associate (Pain/Oncology/CNS Therapeutic Areas).

Key Accountabilities:
<div>
<ul><li>Interact with personnel from study Sponsors, investigational sites, vendors, and Everest functional groups to enable quality and on-time execution of clinical trials in compliance with ICH-GCP and relevant local regulations.</li></ul>
<ul><li>Identify potential sites for participation in clinical trials.</li></ul>
<ul><li>Perform protocol/site feasibility and Pre-Study Visits to recommend qualified sites.</li></ul>
<ul><li>Participate in Investigator Meetings, Clinical Research Associate (CRA) and Study Coordinator training sessions, and assist sites with study-related questions as needed.</li></ul>
<ul><li>Provide feedback to study manuals, Case Report Form completion guidelines, monitoring plans, informed consents, recruitment materials, and monitoring tools, as needed.</li></ul>
<ul><li>Perform Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits in compliance with the approved protocol and monitoring plan.</li></ul>
<ul><li>Submit quality and on-time Monitoring Visit Reports and follow-up letters to the Clinical Operations Lead or designee for review and approval via Clinical Trial Management System (CTMS).</li></ul>
<ul><li>Complete monitoring visit reports and follow-up letters, including summaries of the significant findings, deviations, deficiencies, and recommended actions to ensure site compliance.</li></ul>
<ul><li>Assist with oversight visits and monitoring visit report review/approval of CRA I/II, evaluating their performance and providing feedback to their supervisor, if requested.</li></ul>
<ul><li>Review ISFs to ensure essential documents are current and submitted to the TMF throughout the trial for reconciliation purposes. Ensure sites have submitted relevant documents to their Institutional Review Board/Ethics Committee as needed. The CRA is responsible for ensuring that the TMF is maintained in an inspection-ready state.</li></ul>
<ul><li>Establish regular lines of communication and administer ongoing protocol/study-related training to assigned sites.</li></ul>
<ul><li>Assist with site management tasks and ensure continuous data flow (i.e., on-time site data entry, query resolution, and source document verification). Assess the clinical research site&rsquo;s patient recruitment/retention success and offer suggestions for improvement.</li></ul>
<ul><li>Ensure proper handling, accountability, and reconciliation of all investigational products, medical devices, and clinical trial supplies.</li></ul>
<ul><li>Prepare sites for inspections/audits conducted either by regulatory authorities, Sponsors, or Contract Research Organizations.</li></ul>
<ul><li>Submit accurate and on-time expense reports.</li></ul>
<ul><li>Assist with preparation of materials for Requests for Proposals and bid defenses.</li></ul>
<ul><li>Assist the Clinical Operations team with additional related tasks as needed.</li></ul>
<ul><li>Plan and carry out professional development.</li></ul>
<ul><li>Complete timesheets as requested and on-time.</li></ul>
</div>
Qualifications and Experience:
<div>
<ul><li>Bachelor&rsquo;s degree in a Life Science or related field of study.</li></ul>
<ul><li>Minimum of 4 years&rsquo; of relevant and/or monitoring experience.</li></ul>
<ul><li>Thorough knowledge of ICH-GCP guidelines and applicable regulations.</li></ul>
<ul><li>Demonstrated experience working on clinical trials across Pain (acute and chronic), Oncology, and CNS therapeutic areas.</li></ul>
<ul><li>Thorough comprehension of medical terminology.</li></ul>
<ul><li>Excellent organization and communication skills (both verbal and written).</li></ul>
<ul><li>Ability to travel a maximum of 70% of working hours to locations nationwide. Less travel hours may apply for projects with remote/virtual visits.</li></ul>
<ul><li>Must maintain a valid driver&rsquo;s license and be able to drive to monitor sites.</li></ul>
</div>
To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.ecrscorp.com

Estimated Salary Range: $ 125,000 - 145,000.

We thank all interested applicants, however, only those selected for an interview will be contacted.

Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.</div>

Senior Clinical Research Associate (Pain/Oncology/CNS Therapeutic Areas)

IQVIA

<div><div><div>Durham, United States of America | Full time | Field-based | R1530895</div><div><div>
Job available in additional locations</div></div></div><div><div> 
At IQVIA Biotech, we partner with visionary biotech companies to transform innovation into patient impact. With dedicated teams, deep therapeutic expertise, and a biotech-tailored delivery model, we accelerate clinical development from early phase through global registrational studies.</div><div>
We&rsquo;re seeking an experienced Clinical Research Associate with 1-3 years of onsite monitoring to oversee clinical trial sites and ensure high‑quality study execution. In this role, you&rsquo;ll monitor study activity, support site teams, and ensure adherence to protocols, regulations, and sponsor expectations. Preference would be to have oncology experience but open to other therapeutic areas.</div><div><h3 class="jobSectionHeader">
Key Responsibilities</h3><ul><li>
Conduct site visits (selection, initiation, monitoring, and close‑out) in compliance with GCP, ICH, and study requirements.</li><li>
Partner with sites to drive patient recruitment and meet study enrollment goals.</li><li>
Provide study protocol and procedure training to site staff and maintain consistent communication to support study progress.</li><li>
Assess site performance, data quality, and regulatory compliance; escalate issues when needed.</li><li>
Track study milestones including submissions, approvals, enrollment, data entry, and query resolution.</li><li>
Ensure accurate and complete maintenance of site documentation and Trial Master File materials.</li><li>
Prepare monitoring reports, follow‑up letters, and other required documentation.</li><li>
Collaborate closely with the study team and provide support with start‑up activities as applicable.</li><li>
(If applicable) Support site‑level recruitment planning and financial management.</li></ul><h3 class="jobSectionHeader">
Qualifications</h3><ul><li>
Bachelor&rsquo;s degree in a scientific or healthcare field (or equivalent experience).</li><li>
Minimum 1 year of on‑site clinical monitoring experience.</li><li>
Strong knowledge of GCP/ICH guidelines and clinical research regulatory requirements.</li><li>
Proficiency with Microsoft Office and digital tools (laptop, mobile devices).</li><li>
Excellent communication, organization, and problem‑solving skills.</li><li>
Ability to build strong working relationships with study teams, site staff, and sponsors.</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>
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</div><div>
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.</div>
The potential base pay range for this role, when annualized, is $71,900.00 - $169,300.00. 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></div><div></div>

Clinical Research Associate

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