senior clinical research associate

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>
Join Thermo Fisher Scientific Inc. as a Sr. Clinical Research Associate based in Saudi Arabia and be part of an outstanding team! This is an outstanding opportunity to contribute to groundbreaking research and support scientific advancements in an ambitious and collaborative environment.</p><p><br>
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.</p><p></p><p>
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 Senior Clinical Research Associate, you'll conduct on-site or remote 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 and client company personnel. You may assist the project manager or clinical team manager on assigned projects and/or may assist in the mentoring and training of junior clinical team members. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.</p><p></p><p><b><br>
Key Responsibilities</b></p><ul><li>
Support the Clinical Operations team in the region with the CRO setup and obtention of required licenses.</li><li>
Support study teams as a Subject Matter Expert on different aspects of feasibility, submissions, contract negotiations and startup activities (e.g., Tracking RFPs, Site identification, Advice during EC/RA Submissions).</li><li>
Participate with the local team to customize monitoring plans, operational procedures and tools to ensure accurate approach and adherence to local regulations.</li><li>
Collaborate with cross-functional teams to successfully implement study plans and resolve any issues that arise.</li><li>
Strictly maintain all documentation and records according to company and regulatory standards.</li><li>
Provide guidance and mentorship to junior CRAs, encouraging a culture of inclusion and continuous improvement.</li></ul><p></p><p><b>
What You&rsquo;ll Do:</b></p><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>
Provides updates on potential trends noted across multiple sites and discusses potential strategies for their management to the Clinical Lead.</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. Ensures 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>
Contributes to the project team by mentoring new members, assisting in preparation of project publications/tools including informed consents, CRF guidelines and monitoring plans, and sharing ideas/suggestions with team members. Assists in project specific training for the clinical team where necessary. Identifies areas for potential process improvements &amp; share potential solutions for improvements.</li><li>
Performs additional tasks as assigned by Clinical Lead or Clinical Manager of CRAs (CM-CRA) (e.g. trip report review, newsletter creation, lead CRA team calls etc).</li><li>
Provides trial status tracking and progress update reports to the Clinical Lead as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Perform QC check of reports generated from CTMS system where required.</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 federal regulatory requirements/audits.</li><li>
Maintains &amp; completes administrative tasks such as expense reports and timesheets in a timely manner</li></ul><p><b><br>
Education and Experience Requirements:</b></p><ul><li>
Bachelor's degree in a life science related field 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 5+ years as a clinical research monitor).</li><li>
Valid driver's license</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>
Qualifications</b></p><ul><li>
Proven experience in clinical research, with a minimum of 5 years of experience as a CRA.</li><li>
Comprehensive knowledge of ICH-GCP guidelines and regulatory requirements.</li><li>
Strong analytical skills and attention to detail to determine and address any discrepancies.</li><li>
Outstanding communication and organizational skills to prioritize effectively.</li><li>
Ability to work independently and as part of a collaborative team.</li><li>
Location: Based in Saudi Arabia</li><li>
Languages: Fluent in Arabic and English</li></ul><p><br>
Why Join Us</p><p>
At Thermo Fisher Scientific, we compete at the highest levels to drive innovation and excellence. You'll be part of a team that values diverse perspectives and strives for flawless execution in everything we do. Your contributions will help us make a tangible impact on global health and well-being. Start your story with us today!</p></div><p></p>

Senior Clinical Research Associate (Sr CRA)

ICON plc

<div>US, Senior Clinical Research Associate, Sponsor Dedicated<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 in the Midwest Region to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a key role in early-phase clinical trials, working closely with Clinical Operations leadership and study teams. This is not a narrowly defined, process-heavy role. You will have the opportunity to contribute broadly, problem-solve in real time, and help shape how Phase I studies are executed.</div><div></div><div>
What You Will Be Doing:</div><ul><li><div>
Hands-on involvement across Phase I study start-up, conduct, and close-out</div></li><li><div>
Monitor Phase I clinical trials (on-site and remote)</div></li><li><div>
Support study start-up, site activation, and ongoing site management</div></li><li><div>
Autonomy to manage sites and priorities in a dynamic environment</div></li><li><div>
Exposure to complex early-phase activities and decision-making</div></li><li><div>
Ensure protocol compliance, data integrity, and GCP adherence</div></li><li><div>
Proactively identify and resolve site and study-level issues</div></li><li><div>
Partner closely with Clinical Operations and cross-functional teams</div></li></ul><div>
Your Profile:</div><ul><li><div>
Bachelor's degree in a scientific or healthcare-related field.</div></li><li><div>
Minimum of 2 years of experience as a Clinical Research Associate for a biotech, pharmaceutical company or CRO</div></li><li><div>
Previous CRA experience with Phase I / early-phase trials required</div></li><li><div>
Are comfortable pivoting and working in evolving environments</div></li><li><div>
Strong knowledge of GCP and early-phase clinical trial conduct</div></li><li><div>
Ability to manage multiple priorities independently</div></li><li><div>
Strong communication, adaptability, and problem-solving skills</div></li><li><div>
Are motivated by learning, growth, and visible impact</div></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>

US, Senior Clinical Research Associate, Sponsor Dedicated

<div>US, Senior Clinical Research Associate, Sponsor Dedicated<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 in the Midwest Region to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a key role in early-phase clinical trials, working closely with Clinical Operations leadership and study teams. This is not a narrowly defined, process-heavy role. You will have the opportunity to contribute broadly, problem-solve in real time, and help shape how Phase I studies are executed.</div><div></div><div>
What You Will Be Doing:</div><ul><li><div>
Hands-on involvement across Phase I study start-up, conduct, and close-out</div></li><li><div>
Monitor Phase I clinical trials (on-site and remote)</div></li><li><div>
Support study start-up, site activation, and ongoing site management</div></li><li><div>
Autonomy to manage sites and priorities in a dynamic environment</div></li><li><div>
Exposure to complex early-phase activities and decision-making</div></li><li><div>
Ensure protocol compliance, data integrity, and GCP adherence</div></li><li><div>
Proactively identify and resolve site and study-level issues</div></li><li><div>
Partner closely with Clinical Operations and cross-functional teams</div></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>

Roswell Park Comprehensive Cancer Center

<div><div>Title:</div>
Senior Clinical Center Associate/Clinical Center Associate II (Second Shift/Part Time)<div>
Job Type:</div>
Regular<div>
Company:</div>
Roswell Park Comprehensive Cancer Center<div>
Department:</div>
Perioperative Care Unit<div>
Time Type:</div>
Part time<div>
Weekly Hours:</div>
30<div>
FTE:</div>
0.75<div>
Shift:</div>
Second Shift (United States of America)<div></div><div>
Summary:</div>
We are seeking a part time Senior Clinical Center Associate or Clinical Center Associate II to work in our Perioperative Care Unit department.<br>
<br>
The Senior Clinical Center Associate Performs highly confidential and complex administrative duties as the systems coordinator within the department; manages sensitive compartmented information (SCI) scheduling application; assists in the development, building and implementation of scheduling templates and serves as ambulatory liaison with IT for template modifications; provides training and ongoing development for Clinical Center Associates (CCA&rsquo;s) and other clinical personnel; analyzes and establishes process improvements to optimize billing protocol. The starting hourly rate for this position is $27.32.<br>
<br>
The Clinical Center Associate II performs increasingly complex clerical support functions in an assigned inpatient or outpatient center(s) of the organization; answers routine inquiries; screens calls; assists visitors and patients; records and transcribes physician orders; maintains and coordinates clinic schedules; manages the co-pay collection process; participates in the team or group work activities in the center(s); performs the above duties and responsibilities in a confidential environment requiring direct supervision with limited latitude for utilizing judgment and initiative. The starting hourly rate for this position is $24.39.<div></div><div>
Qualifications:</div>
Required Education and Experience for Senior Clinical Center Associate<br>
<br>
1. Medical Office Assistant Associate&rsquo;s degree and the equivalent of four (4) years of full-time administrative support experience in a clinical setting requiring the use of medical terminology; or<br>
2. Associate&rsquo;s degree and the equivalent of five (5) years of full-time administrative support experience in a clinical setting requiring the use of medical terminology; or<br>
3. High School diploma or High School Equivalency Diploma, completion of an Roswell Park-approved Medical Assistant certificate program and the equivalent of five (5) year of full-time administrative support experience in a clinical setting requiring the use of medical terminology; or<br>
4. High School diploma or High School Equivalency Diploma and the equivalent of six (6) years of full-time administrative support experience in a clinical setting requiring the use of medical terminology; or<br>
5. High School diploma or High School Equivalency Diploma and the equivalent of five (5) year of full-time experience in customer service and successful completion of a Clinical Center Associate traineeship at Roswell Park Comprehensive Cancer Center (Roswell Park).<br>
<br>
NOTE:<br>
Degrees must be conferred by an accredited school, college, or university, or by an institution recognized by Roswell Park Comprehensive Cancer Center and/or Health Research Incorporated as adhering to acceptable educational standards.<br>
<br>
Required Education and Experience for Clinical Center Associate II<br>
<br>
1. Medical Office Assistant Associate&rsquo;s degree and the equivalent of two (2) years of full-time administrative support experience in a clinical setting requiring the use of medical terminology; or<br>
2. Associate&rsquo;s degree and the equivalent of three (3) years of full-time administrative support experience in a clinical setting requiring the use of medical terminology; or<br>
3. High School diploma or High School Equivalency Diploma, completion of an Roswell Park-approved Medical Assistant certificate program and the equivalent of three (3) years of full-time administrative support experience in a clinical setting requiring the use of medical terminology; or<br>
4. High School diploma or High School Equivalency Diploma and the equivalent of four (4) years of full-time administrative support experience in a clinical setting requiring the use of medical terminology; or<br>
5. High School diploma or High School Equivalency Diploma and the equivalent of three (3) years of full-time experience in customer service and successful completion of a Clinical Center Associate traineeship at Roswell Park Comprehensive Cancer Center (Roswell Park).<br>
<br>
NOTE:<br>
Degrees must be conferred by an accredited school, college, or university, or by an institution recognized by Roswell Park Comprehensive Cancer Center and/or Health Research Incorporated as adhering to acceptable educational standards<div></div><div>
Preferred Qualifications</div><div>
The ideal candidate should have at least one year of experience as a Medical Secretary or in a similar healthcare administrative role. They must have strong knowledge of patient scheduling, appointment coordination, and front‑office workflow. Excellent customer service skills are essential, with the ability to communicate professionally, support patient needs, and maintain a welcoming environment.</div><div></div><div>
Equal Employment Opportunity Statement</div><div>
Roswell Park Cancer Institute Corporation (RPCIC) and Health Research Inc. (HRI) Roswell Park Division believe that all persons are entitled to equal employment opportunities, and we do not discriminate against our employees, applicants or job seekers because of their race, color, religion, sex, sexual orientation, gender identity or expression, national origin, creed, age, disability, pregnancy-related condition, military or veteran status, marital or familial status, domestic violence victim status, citizenship status, genetic information, individual&rsquo;s relationship or association with a member of a protected category or any other protected group status as defined by law.</div><div></div><div>
Reasonable Accommodation Request</div><div>
RPCIC and HRI are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email <div>HR-PayAndBenefits@RoswellPark.org</div> and let us know the nature of your request and your contact information.</div><div></div><div>
Our Core Values</div><div>
RPCIC and HRI are committed to providing an environment where patients, families, employees and community are treated with courtesy and respect. We support an inclusive environment that nurtures the talents, skills and abilities of each individual to embody and reflect our core values: Innovation, Integrity, Teamwork, Commitment, Compassion and Respect.</div><div></div><div>
Historical Compensation Information Statement</div><div>
Pursuant to Executive Order 161, no State entity, as defined by the Executive Order, is permitted to ask, or mandate, in any form, that an applicant for employment provide his or her current compensation, or any prior compensation history, until such time as the applicant is extended a conditional offer of employment with compensation. If such information has been requested from you before such time, please contact the Governor&rsquo;s Office of Employee Relations at (518) 474-6988 or via email at <div>info@goer.ny.gov</div>.</div></div>

Senior Clinical Center Associate/Clinical Center Associate II (Second Shift/Part Time)

Alameda Health System

<div><div><div><p><b>SUMMARY: </b>Under direction of the Manager of Grants &amp; Special Projects, the Clinical Research Associate coordinates all aspects of clinical trials within the assigned unit.at the Adult Immunology Clinic, Highland Campus. In consultation with providers and other clinical personnel, is responsible for selecting, implementing and monitoring clinical trials, educating, and when appropriate, enrolling patients into the various programs. Performs related duties as required.</p>
<p><b>DUTIES &amp; ESSENTIAL JOB FUNCTIONS:</b> NOTE:<b> </b>The following are the duties performed by employees in this classification. However, employees may perform other related duties at an equivalent level. Not all duties listed are necessarily performed by each individual in the classification.</p>
<p>CLINICAL TRIALS:<b> </b>Responsible for assisting in the selection and administration of appropriate clinical research trials by reviewing studies, adhering to federal regulations and ICH Guidelines, with an emphasis on good clinical practice and clinical Safety Data Management. Administers informed consent, enrollment of participants into clinical trials.</p>
<p>INSTITUTIONAL REVIEW BOARD (IRB): Acts as departmental representative at Institutional Review Board&rsquo;s Human Subject Committee meetings. Presents all new research projects to the committee. Modifies, renews and closes out all appropriate research projects. Reports all serious adverse events and protocol violations. Submits drug and/or device safety reports to the IRB.</p>
<p>REGULATORY: Organizes research team and meets as needed. Maintains current CVs and licenses for all study investigators. Updates regulatory binders for each research study. Provides central protocol and drug information to departments. Educates hospital personnel regarding protocols and screening requirements. Reports serious adverse events to study sponsor and FDA, when appropriate. Ensures compliance with all federal and state laws regarding research and confidentiality. In collaboration with nursing staff, assures that operations are in compliance with external guidelines, statutory and accreditation parameters including JCAHO, Title 22, HCFA, OSHA, and other laws/regulations</p>
<p>PRESENTATION AND PUBLICATIONS: Assists investigators in the preparation of manuscripts and the design of posters and oral presentations for annual conventions, conferences and trainings, when appropriate. Performs searches through existing medical literature.</p>
<p>ADMINISTRATIVE/FISCAL: Organizes research team (nurses, co-investigators) and meets with team, as needed. Maintains current CVs and licenses for all sub investigators and binders for each protocol. Acts as the point person for budgetary and administrative issues. When appropriate, prepares and negotiates study budget. Monitors and accounts for all study related income and expenses. Requests and administers patient compensation and petty cash. Provides scheduled accounting of research funds to department directors. Interacts with AHS staff in a professional and courteous manner. Supervises research personnel to ensure compliance with protocols. Obtains, interview, and directly supervise research department volunteers and medical students on research elective rotations.</p>
<p><b>MINIMUM QUALIFICATIONS:</b></p>
<p>Education: Bachelor&rsquo;s Degree (180 quarter units or 120 semester units) with major coursework in health and human sciences, biology or a field related to the work. (Additional experience as outlined below may be substituted for the education on a year-to-year basis.)</p>
<p>Minimum Experience: Possess experience and expertise in medical research. Experience and expertise can be gained by &ldquo;hands-on experience&rdquo; in a medical or scientific setting, as a graduate or medical student or other medically trained individual. Typically equal to the equivalent of two years of full-time experience as a Clinical Research Associate or equivalent level position at a public hospital, medical center or HMO.</p>
<p>Required Licenses/Certifications: BLS - Basic Life Support Certification issued by AHA-American Heart Association.</p></div><br>
</div><br>
Location: Alameda Health System &middot; HGH Opioid Use Disorder Grant<br>
Schedule: Full Time, Day</div>

Clinical Research Associate

IQVIA

<div><div><div>Riyadh, Saudi Arabia | Full time | Hybrid | R1529346</div></div><p></p><div><div><b><br>
Project Leads</b> are an integral part of clinical trial delivery, liaising with clinical teams to improve patients&rsquo; lives by bringing new drugs to the market faster. The Project Lead is an essential member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs, policies and practices.</div><div><b>
Clinical Project Management </b>is focused on project delivery, productivity and quality resulting in strong financial performance and customer satisfaction. Clinical Project leads can run their own studies. The Project Lead focus is on leveraging therapeutic expertise and IQVIA&rsquo;s suite of solutions to drive operational excellence and strategic leadership with our customers.</div><div><b>
Main Responsibilities</b><br>
<ul><li>Accountable for the execution of clinical studies, or assigned portion of clinical studies, per contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.</li><li>Set objectives of the core project team according to agreed upon contract, strategy and approach, effectively communicate and assess performance.</li></ul></div><ul><li>Participate in bid defense presentations in partnership with Business Development and may lead the presentation for smaller, less complex regional studies.</li><li>May be responsible for delivery and management of smaller, less complex, regional studies.</li><li>Develop integrated study management plans with the core project team.</li><li>Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.</li><li>Monitor progress against contract and prepare project information proactively to stakeholders internally and externally.</li><li>Manage risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts.</li><li>Achieve project quality by identifying quality risks and issues, responding to issues raised by project team and implementing appropriate corrective and preventative action plans.</li><li>Build the cross-functional project team and lead their efforts; responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.</li><li>Ensure the financial success of the project.</li><li>Identify changes in scope and manage change control process as necessary.</li><li>Support staff development and mentor less experienced project team members.</li></ul><div><b>
Required Skills and Qualifications</b><br>
<ul><li>Bachelor's Degree Life sciences or related field.</li><li>5 years of prior relevant experience including at least 2 years of prior work experience in a Senior Clinical Research Associate role.</li></ul></div><ul><li>At least 1 years project management experience or equivalent combination of education, training and experience is preferred.</li><li>Therapeutic area knowledge in any of the following would be an advantage: oncology, rare diseases is preferred.</li><li>Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct.</li><li>Good understanding of project financials including experience managing, contractual obligations and implications.</li><li>Strong written and verbal communication skills including very good command of English and Arabic language.</li><li>Strong customer service skills and presentation abilities.</li><li>Planning, time management and prioritization skills.</li><li>Ability to organize resources needed to accomplish tasks, set objectives and provide clear direction to others, experience planning activities in advance and taking account of possible changing circumstances.</li><li>Good software and computer skills.</li></ul><div>
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com</div><div>
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.</div></div></div><div></div>

Associate Clinical Project Manager

Columbia University

<p><b>Job Summary</b><br/>A position of Staff Associate I is available starting in March 2026 in the group of Dr. Remi Creusot at the Columbia Center for Translational Immunology (CCTI) to participate in research investigating the pathophysiology and therapy of Type 1 diabetes (T1D). This position offers a unique opportunity to work in a highly multidisciplinary environment interfacing immunology, diabetes and immuno-engineering. The CCTI connects multiple basic and clinical departments and other research centers within Columbia University Medical Center; it was established to promote horizontal translation of applied immunology between different disciplines and to advance immunology from the bench to the clinic. The Creusot lab is also affiliated with the Naomi Berrie Diabetes Center, providing access to renowned diabetes experts.</p><p><b>Responsibilities</b></p><p>The new team member will devote ~50% effort on various lab and animal colony management, including screening of mice through genotyping (PCR) and phenotyping (flow cytometry), and assisting with the longitudinal monitoring of experimental mice (analysis of blood samples) and surgical procedures. In addition, the lab member will focus ~50% of the time on projects to generate research data for publications and grant applications, either independently or under the supervision of senior lab members.</p><p><b>Qualifications</b></p><p>The candidate should have BS/BA degree in Biomedical Sciences with at least 4 years of lab experience (or 2 years after a MS/MA degree) and proven track record of productivity (contribution to publications). In addition, the successful candidate will demonstrate strong scientific rigor, work ethics, motivation and ability to work in a highly collaborative environment. Experience with flow cytometry, basic molecular biology techniques (PCR, electrophoresis), in vitroimmunoassays, animal procedures (including surgery), isolation and culture of immune cells is highly desirable.</p><p>Applicants should send a full CV, a one-page cover letter highlighting research interests and career goals, and the name and contact details of 2 references directly to the Principal Investigator.</p><p>Job Type: Full-time</p><p>Pay: $64,500.00 per year</p><p>Benefits:</p><ul><li>401(k)</li><li>401(k) matching</li><li>Dental insurance</li><li>Health insurance</li><li>Health savings account</li><li>Paid time off</li><li>Vision insurance</li></ul><p>Work Location: In person</p>

Staff Associate I - Columbia University Medical Center

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Staff Associate I - Columbia University Medical Center