clinical trial specialist

Acino

<div><p>only applicants with requested experience will be consideredArcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets. With an operational footprint spanning over 90 countries across four continents, and manufacturing sites in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide.</p><p></p><p><br>
This position, reporting to the Clinical Trial Manager/Clinical Trial Director, will be based in Obour and hired under Legacy Amoun (part of Arcera) employment contract.</p><p></p><p><b><br>
Main </b><b>duties</b></p>
<ul>
<li>Serves as a primary operations contact for internal and external study team members on assigned local and global studies/projects</li>
<li>Participation in update of the data base of vendor, including CRO</li>
<li>Responsible for Good Documentation Practice of the study including Sponsor Trial Master File assuring compliance of clinical trials with SOPs and local regulations, ICH, and GCP guidelines.</li>
<li>Assures protocol compliance and training of study personnel, participants and contracted vendors.</li>
<li>Participates in preparation and submission of dossiers for clinical trial applications and clinical documentation in dossiers for new marketing authorizations based on defined regulatory strategy and timelines</li>
<li>Coordinates and support with needed documents when third parties assigned for the submissions to independent ethics committees IECs) and institutional research boards when</li>
<li>Acts as contact person for Clinical activities during Product Development, the Out-licensing Team, Business Development, Global Medical Affairs, PV, and external service providers on all types of new projects clinical trials activities</li>
<li>Participates in due diligence of clinical and related medical documentation</li>
<li>Participates in timely response to requests for supplementary information (deficiency letters) to clinical part from Regulatory Competent Authorities</li>
<li>Assures data administration in internal clinical trials database</li>
<li>Develops and maintains a thorough and up-to-date understanding of the clinical trials regulatory environment, pathways and supporting data requirements</li>
<li>Evaluates and improves regulatory and clinical trials compliance</li>
<li>Develops clinical knowledge and due diligence capabilities within the team</li>
<li>Responsible for achieving assigned KPIs</li>
</ul>
<p><b>Job Requirements</b></p>
<ul>
<li>Degree in biomedical sciences (Medicine/Pharmacy/Veterinary/Pharmaceutical Sciences/ Science) or Chemistry.<br>
</li>
<li>Excellent communication skills, both verbal and written, with a passion for accuracy and attention to detail.</li>
<li>Excellent interpersonal skills &ndash; ability to interact effectively with a diverse group of people from different functions, of different nationalities and at different levels within the company.</li>
<li>Good written and oral knowledge of English.</li>
<li>Skilled at leading non complex projects and clinical trials.<br>
</li>
<li>Willingly accepts challenging assignments and new career opportunities that stretch and build capabilities.</li>
<li>Knowledge of pharmaceutical and clinical trials regulatory processes</li>
<li>In depth knowledge of GCP guidelines, in particular related to the sponsor role of clinical trials.</li>
<li>Understanding of Operational activities in clinical trials.</li>
<li>Leads interactions with third party providers and consultants during all stages of the clinical (and preclinical if needed) clinical trial operational process.</li>
<li><b>only applicants with requested experience will be considered.</b></li></ul><br>
<p></p>
<p>
This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!</p></div>

Clinical Trial Specialist

Quest Diagnostics

<div><p><b>Clinical Trial Study Specialist - Seattle, WA, Monday to Friday, 8:00 AM to 5:00 PM | Hybrid, 3 days onsite a week</b></p><p></p><p><b><br>
Pay range: $78,450 - $141,200 / year</b></p><p>
Salary offers are based on a wide range of factors including relevant skills, training, experience, education, and, where applicable, certifications obtained. Market and organizational factors are also considered. Successful candidates may be eligible to receive annual performance bonus compensation.</p><p></p><p><b><br>
Benefits information:</b><br>
We are proud to offer best-in-class benefits and programs to support employees and their families in living healthy, happy lives. Our pay and benefit plans have been designed to promote employee health in all respects &ndash; physical, financial, and developmental. Depending on whether it is a part-time or full-time position, some of the benefits offered may include:</p><ul><li>
Day 1 Medical, supplemental health, dental &amp; vision for FT employees who work 30+ hours</li><li>
Best-in-class well-being programs</li><li>
Annual, no-cost health assessment program Blueprint for Wellness&reg;</li><li>
healthyMINDS mental health program</li><li>
Vacation and Health/Flex Time</li><li>
6 Holidays plus 1 &quot;MyDay&quot; off</li><li>
FinFit financial coaching and services</li><li>
401(k) pre-tax and/or Roth IRA with company match up to 5% after 12 months of service</li><li>
Employee stock purchase plan</li><li>
Life and disability insurance, plus buy-up option</li><li>
Flexible Spending Accounts</li><li>
Annual incentive plans</li><li>
Matching gifts program</li><li>
Education assistance through MyQuest for Education</li><li>
Career advancement opportunities</li><li>
and so much more!</li></ul><p>
The Clinical Trial Study Specialist is primarily responsible for coordinating the execution of clinical trial projects including working with the Clinical Trial Study Manager to help manage the scope, timeline and budget of assigned projects.</p><div>
<div><div><div>Quest Diagnostics honors our service members and encourages veterans to apply.<br>
<br>
While we appreciate and value our staffing partners, we do not accept unsolicited resumes from agencies. Quest will not be responsible for paying agency fees for any individual as to whom an agency has sent an unsolicited resume.<br>
<br>
Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets or any other legally protected status.</div>
</div><br>
</div></div><ul><li>Review contracted scope, budget and timeline to develop a plan of action or multiple plans of action to successfully complete project.</li>
<li>Coordinate with scientific and technical directors as the scientific leaders for the project.</li>
<li>Coordinate with appropriate technical staff within the laboratory operations to ensure operational plan is achievable and appropriate resources are available for scope.</li>
<li>Identify risks that may impact our ability to successfully complete the scope of the project in the timeline or budget available and communicate those to the Clinical Trial Study Manager.</li>
<li>Identify new or out of scope requests from customer and communicate with Clinical Trial Study Manager so contract modifications can be implemented.</li>
<li>Maintain official project records from inception to completion including archiving.</li>
<li>Ensure that contracted work is conducted within regulatory requirements (FDA, EMEA, GCLP).</li>
<li>Assist Clinical Trial Study Manager in developing overall project plan and maintain regular touch points to ensure that timelines are being met.</li>
<li>Communicate with customer about discordant samples, shipping and receiving samples</li>
<li>Tracking, storage, and shipping of samples throughout project lifecycle</li>
<li>Act as a backup for the project manager during times of absence, leading client communication and management of Quest team.</li>
<li>Resolve sponsor queries.</li>
<li>Other duties as assigned.</li>
</ul><p><b>
Required Work Experience:</b></p>
<ul>
<li>1-2 years of healthcare experience or equivalent education and experience.</li>
</ul>
<p><b>Preferred Work Experience:</b></p>
<ul>
<li>Previous work in GXP environment desired</li>
<li>Previous laboratory experience preferred.</li>
</ul>
<p><b>Physical and Mental Requirements:</b></p>
<ul>
<li>Ability to sit for extended periods of time.</li>
<li>Ability to stand for extended periods of time.</li>
<li>Must regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds.</li>
<li>Ability to use fine motor skills to operate office equipment.</li>
<li>Ability to receive and comprehend instructions verbally and/or in writing.</li>
<li>Ability to use logical reasoning for simple and complex problem solving.</li>
</ul>
<p><b>Knowledge:</b></p>
<ul>
<li>N/A</li>
</ul>
<p><b>Skills:</b></p>
<ul>
<li>Excellent verbal and written communication skills.</li>
<li>Exceptional interpersonal skills and business acumen.</li>
<li>Strong organizational skills; very detail oriented and a self-motivated problem solver.</li>
<li>Ability to multitask and prioritize with little assistance from other staff</li>
<li>Knowledge of Microsoft Word, Excel, PowerPoint, and Outlook</li></ul></div>

Clinical Trial Study Specialist

Bristol Myers Squibb

<p><b>Working with Us</b><br>
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.<br>
<br>
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .<br>
<br>
<b>Job Title
</b><br>
Clinical Trial Registration Sr. Specialist<br>
<b>Division
</b><br>
Research &amp; Development
<br>
<b>Functional Area Description
</b><br>
Global Development Operations / Trial Delivery Support (TDS) / Trial Risk and Integrity Management (TRIM)/ CT Transparency &amp; Submission
<br>
<b>Position Summary / Objective
</b><br>
The Clinical Trial Registration Sr. Specialist will report to the Clinical Trial Registration Lead, prepare and provide operational support for the registration and maintenance of clinical trials into public registries in US, EU and other countries as required.<br>
<b>Position Responsibilities
</b><br>
Drives the processes for assigned protocol registration activities, resulting in timely, high-quality information posted on clinical trial registries (Clinicaltrials.gov and EU PAS).
<br>
<br>
Liaises with clinical team reviewers (Global Trial Managers, Operations Leads, Statisticians, Clinical Trial Physicians, Clinical Scientists, Development Leads, Patent Attorneys) and other stakeholders on all assigned trials to ensure trial registrations are accurate, consistent with the protocol and other source data, and reported in adherence to NIH guidelines.
<br>
<br>
Provides maintenance support to CT Registration Lead for assigned records, to ensure the consistent accuracy of information disclosed on Clinicaltrials.gov.
<br>
<br>
Submits registration updates to Clinicaltrials.gov on behalf of clinical team, within global regulatory timelines.
<br>
<br>
Maintains study trackers and ensures they are up to date every week.
<br>
<br>
Educates stakeholders, as needed, on NIH detailed review criteria for registrations as well as on the purpose and format of the different fields in the protocol registration form.
<br>
<br>
Support registration of clinical trials in public registries beyond US/EU as needed.
<br>
<b>Degree Requirements
</b><br>
Bachelor's degree, preferably in a Science-related field
<br>
<b>Experience Requirements
</b><br>
Minimum of 3 years overall work experience, preferably in a biopharmaceutical or CRO company
<br>
<br>
Work experience in quality, regulatory, compliance, clinical research or drug development highly desirable
<br>
<br>
Work experience in clinical trial transparency or clinical trial execution work, or work experience related to quality and compliance in clinical research preferred
<br>
<b>Key Competency Requirements
</b><br>
Demonstrated Excel and analytical skills
<br>
<br>
Ability to work in a multi-functional team and across multiple therapeutic areas
<br>
<br>
Demonstrated ability to work independently and seek out support when needed&quot;&quot;
<br>
<br>
Written and oral communication skills&quot;&quot;
<br>
<br>
Strong organizational skills with the ability to multitask and prioritize, and take on new initiatives and improvement efforts.<br>
<br>
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
<br>
<br>
<b>Uniquely Interesting Work, Life-changing Careers</b><br>
With a single vision as inspiring as Transforming patients' lives through science&trade; , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.<br>
<br>
<b>On-site Protocol</b><br>
<br>
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
<br>
<br>
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
<br>
<br>
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.
<br>
<br>
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
<br>
<br>
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.<br>
<br>
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
<br>
<br>
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.</p>

Clinical Trial Registration Specialist

Johnson & Johnson

<div><p>At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com</p><p><b>
Job Function:
</b></p>MedTech Sales<p><b>
Job Sub Function:
</b></p>Technical Sales - MedTech (Commission)<p><b>
Job Category:</b></p>
Professional<p><b>
All Job Posting Locations:</b></p>
Boston, Massachusetts, United States of America, Chicago, Illinois, United States, Dallas, Texas, United States, Danvers, Massachusetts, United States of America, Los Angeles, California, United States of America, New York, New York, United States, Orlando, Florida, United States of America<p><b>
Job Description:</b></p><p><b>
About Cardiovascular</b></p><p>
Fueled by innovation at the intersection of biology and technology, we&rsquo;re developing the next generation of smarter, less invasive, more personalized treatments.</p><p>
Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that&rsquo;s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.</p><p>
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech</p><p>
This is a field-based role available in all states/cities within United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.</p><p><b>
We are searching for the best talent for Field Research Specialist.
</b></p><p><b>Purpose:</b> We are seeking an experienced, high caliber <b>Field Research Specialist, </b>this is a field-based position for the U.S. Preferred candidates will be located near a major airport and have a strong clinical background in procedural areas.</p><p>
The Field Research Specialist is a dual-role position that combines field-based clinical research engagement, technical expertise in medical device support, and on call, bedside clinical support. This individual serves as a critical bridge between research operations, clinical trial execution, and procedural/device support.</p><p>
This individual will be responsible for driving clinical trial enrollment, retention, and building trusted partnerships with investigators, coordinators, and multidisciplinary teams. They will optimize patient safety, mitigate trial enrollment barriers, and ensure robust data integrity. Collaborating cross-functionally with JNJ Heart Recovery stakeholders and leveraging strong relationships with clinical site personnel including physicians, nurses, and clinical research specialists, the FRS supports site selection and startup, drives patient recruitment, ensures protocol and data compliance, provides on call bedside technical/device support for clinical procedures, supports challenging technical/protocol troubleshooting scenarios, critical software or product testing, and site closeouts.</p><p>
As a subject matter expert on clinical trial protocol and technologies, the Field Research Specialist acts a liaison between Abiomed and the medical community, constantly communicating important information to investigators and customers &ndash; and parlaying clinical trial experience, knowledge, and feedback (&ldquo;Voice of Investigator&rdquo;) to Abiomed cross-functional partners such as R&amp;D, medical affairs, marketing, sales, and education.</p><p><b>
You will be responsible for:</b></p><ul><li>
Provides field support for clinical research related enrollment and procedures.</li><li>
Serve as a technology, protocol and clinical trial procedure expert and resource Abiomed stakeholders, physicians, and research personnel at the site.</li><li>
Develop and maintain in depth knowledge of clinical trial sites.</li><li>
Understand and assess investigators&rsquo; interests and qualifications.</li><li>
Identify appropriate investigators as defined by study-specific requirements and by the applicable regulatory code.</li><li>
Maintain open communication and relationships with key site personnel including the Principal Investigator, Research Coordinator, as well as regulatory and legal personnel.</li><li>
Proactively and critically examine ways to enhance overall clinical trial performance.</li><li>
Facilitate communication between clinical trial sites and other Abiomed clinical staff (e.g., CRA, study team, Contracts Associate), as needed.</li><li>
Manage the following aspects of study progress, including, but not limited to:<ul><li>
Start Up</li><li>
Nominate, approach, and complete qualification processes including establishing site/sponsor expectations for study execution.</li><li>
Facilitate contract/budget escalations as part of the start-up process</li><li>
Train facility staff regarding protocol requirements and technology.</li><li>
Develop site-specific strategies to promote appropriate patient enrollment. Identify site successes and challenges and assist in implementing troubleshooting techniques that promote study goal achievement.</li><li>
Provide ongoing feedback concerning all aspects of study progress, specifically enrollment and procedure related, for the purpose of developing and implementing strategies that will optimize patient safety and contribute to organizational and corporate goals/objectives.</li></ul></li><li>
Provide support for all study-related aspects to research partners, including but not limited to the following questions: technical, protocol, standard of care, clinical trial reimbursement, etc.</li><li>
Provides on call, bedside case coverage for multiple clinical trials and clinical trial sites.</li><li>
Provides back up support in the following areas, trouble shooting, in-service training to physicians and healthcare professionals.</li><li>
Responsible for product reporting and troubleshooting with customers and field personnel within the clinical research portfolio.</li><li>
Collaborate with and provide feedback to Clinical Scientists and study teams in the development of clinical study deliverables, such as protocol design, source documentation, work instructions, patient recruitment materials and product training.</li><li>
Identify and communicate best practices relevant to clinical trial execution.</li><li>
Seek opportunities to continue demonstrating and developing technical, research, and organizational leadership qualities.</li><li>
Collaborate with Clinical Affairs, Medical Affairs, R&amp;D, marketing, and commercial teams to support and advance key projects.</li><li>
Serve as a scientific interface with healthcare professionals.</li><li>
Act as resource in corporate product education as it relates to investigative technologies, as necessary: development, review, and initiation and maintenance of vault approval of training materials, presentations, regional and national product launches, and commercial field education.</li><li>
Develop collaborative cross-divisional team relationships.</li><li>
Provides engineering, education and clinical support in response to field-based inquiries on as needed basis.</li><li>
Transfers clinical trial knowledge and experience into meaningful input and feedback to cross functional partners in R&amp;D, medical affairs, marketing, sales, and education.</li><li>
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
</li></ul><p><b>Qualifications/Requirements
</b></p><ul><li>Bachelor&rsquo;s degree in engineering, nursing, biological sciences, a related field, equivalent or related certification in cardiology.</li><li>
Typically, a minimum of 5 years of relevant clinical experience, with in-depth knowledge of cardiology, and related cardiovascular technologies</li><li>
Direct patient support in Cath lab and operating room is a plus.</li><li>
Availability for to work on call for emergent clinical trial support required.</li><li>
Ability to work in a highly matrixed and geographically diverse business environment.</li><li>
Ability to leverage and/or engage others to accomplish projects.</li><li>
Advanced verbal and written communications with ability to effectively communicate at multiple levels in the organization. Exceptional presentation and influence skills.</li><li>
Required clinical research experience in medical devices.</li><li>
Knowledge of Good Clinical Practices and trials, including feasibility IDE.</li><li>
Multitasks, prioritizes, and meets deadlines in timely manner.</li><li>
Strong organizational and follow-up skills, as well as attention to detail.</li><li>
Ability to travel approximately 70% domestically.</li></ul><p>
Johnson &amp; Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
</p><p>Johnson &amp; Johnson is committed to providing an interview process that is inclusive of our applicants&rsquo; needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.</p><p><b>
Required Skills:
</b></p><p><b>Preferred Skills:</b></p>
Communication, Customer Centricity, Innovation, Market Expansion, Market Research, Medicines and Device Development and Regulation, Proactive Behavior, Problem Solving, Product Knowledge, Sales Engineering, Solutions Selling, Strategic Sales Planning, Sustainable Procurement, Vendor Selection</div>

Field Research Specialist

Minerva Research Solutions

<div><h2 class="jobSectionHeader"><b>Job description</b></h2><p>
Minerva Research Solutions is a clinical trial management service provider. We aim to transform the landscape of healthcare and research with our quality clinical services. We support the biotech, medical, and pharma industries through all phases of the clinical trial lifecycle.</p><p>
Our services include Data Operation, Recruitment Services, and Regulatory. Our goal is to speed up the lifecycle of novel therapies through streamlined processes, stringent timelines &amp; real-time solutions. Our clinical trial support services &amp; consultations are tailored to foster your product and requirements.<br>
<br>
We aim to deliver high-quality data and solutions to make your clinical trials a success. We follow stringent FDA and GCP regulations throughout all phases of the clinical trial process.<br>
<br>
Minerva Research Solution is looking for dynamic individuals in the role of Patient Enrollment Specialist responsible for screening new leads, conducting follow-ups, and documenting participants for assigned active clinical trials. This specialist contributes significantly to clinical trials by building a comprehensive database in the Clinical Trial Management System (CTMS) of willing and qualified study volunteers.</p><p><b>
Industry:</b></p><ul><li>
Information Technology &amp; Services</li><li>
Hospital &amp; Health Care</li><li>
Clinical-Trials and Research Industry</li></ul><p><b>
Key Responsibilities:</b></p><ul><li>
Conduct phone interviews and screenings for prospective clinical study participants in US.</li><li>
Maintain an organized database of clinical study participants.</li><li>
Develop outreach strategies to enhance participant recruitment.</li><li>
Interact directly with study participants via phone calls, SMS, etc.</li><li>
Collaborate with Medical Staff (CRCs) to ensure adequate subject recruitment for each study.</li><li>
Enhance and maintain study documentation and volunteer records, including consent forms.</li><li>
Assist in sales, marketing, and outreach efforts as needed.</li><li>
Provide accurate study-related information to participants in US.</li><li>
Cultivate a safe, positive, and fast-paced work environment.</li><li>
Undertake other related duties and participate in special projects as assigned.</li></ul><p><b>
Behavioral Competencies:</b></p><ul><li>
Conceptual capability, problem-solving, and decision-making ability.</li><li>
Strong commitment to teamwork, work ethics, and etiquette.</li><li>
Effective planning and organizing skills with priority setting.</li><li>
Proactive knowledge and information sharing within the team.</li><li>
Customer-focused with strong communication skills.</li><li>
Active learning attitude with a continuous improvement mindset.</li></ul><p><b>
Minimum Qualifications:</b></p><p><b>
Essential:</b></p><ul><li>
Bachelor&rsquo;s Degree in BDS, Pharm-D.</li><li>
Good knowledge of Clinical Trials.</li><li>
Computer literate with good knowledge of MS Office.</li><li><b><i>
Proficiency in the English language written and spoken both.(MANDATORY)</i></b></li><li>
Therapeutic Communication in English with US accent is preferred.</li><li>
6 months to 1 year experience in a relevant field.</li></ul><p><b>
Benefits:</b></p><ul><li>
Competitive salary and performance-based bonuses.</li><li>
Quarterly Bonus Structure.</li><li>
Medical health insurance coverage for you and your family (Spouse &amp; Children).</li><li>
Employees Old-age benefits coverage.</li><li>
40-hours Week.</li><li>
Exposure to US Market.</li><li>
Professional learning and development support.</li><li>
Generous vacation and paid time off.</li><li>
Employee assistance programs for mental health.</li><li>
Company-sponsored events and team-building activities.</li><li>
Diverse, professional and inclusive work environment.</li><li>
Opportunities for career growth.</li><li>
Cutting-edge technology and tools.</li><li>
Family-friendly policies, including parental leave.</li><li>
Commuter benefits or transportation assistance.</li><li>
Social responsibility and community involvement programs.</li></ul><b>
Openings:</b><ul><li>
Equal opportunity employers</li><li>
Full-time</li><li>
On-site job <b>(Night shift)</b></li></ul><p><b><br>
Work Schedule Timings:</b></p><ul><li>
Monday to Friday</li><li>
7 PM to 3 AM (transport facility provided for female staff only and allowance for male employees, additional night shift allowance)</li></ul><p>
</p><p>VqJLaFnOod</p></div>

US Patient Enrollment Coordinator (Evening Shift)

ICON plc

<div>CTA, (Pricing &amp; Payments), Remote US<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 Clinical Trial Consulting Ops Snr Associate (Payments) to join our diverse and dynamic team. As a Clinical Trial Consulting Ops Snr Associate at ICON, you will play a critical role in overseeing and supporting the execution of clinical trail committee contracts, ensuring the highest standards of quality, compliance, and efficiency. You will collaborate with various teams to manage trial operations, address clinical challenges, and contribute to the successful delivery of research projects.</div><div>
What You Will Be Doing:</div><ul><li><div>
Key Responsibilities</div><ul><li>Setup agreements and perform Compliance checks for HCP/HCOs for clinical trial consulting agreements for clinical trial committees.</li><li>Manage payment process for HCP/HCO agreements.</li><li>Perform compliance checks on HCPs related to clinical trial committee requirements.</li><li>Manage compliance checks, system documentation and payment process for HCP meetings.</li></ul><div></div><div>
Department processes and procedures</div><ul><li>Ensure compliance &amp; legal requirements are met for HCP contracts per country requirements.</li><li>Contract generation.</li><li>Budget generation within FMV</li><li>Interpret country compliance requirements and recognize when to escalate to country compliance lead.</li><li>PO generation and change orders.</li><li>Supplier onboarding</li><li>Process payments to ensure consistency with contracts and compliance guidelines.</li><li>Ensure meeting related logistics and meals are within country</li></ul><div>
requirements.</div><ul><li>Maintain accurate consultancy and payment records.</li><li>Provide Oversight and Coordination of all centralized operations activities for clinical trial arrangements.</li></ul><div></div><div>
Communication</div><ul><li>Liaise with other departments local and global clinical teams to obtain necessary information required to manage processes.</li></ul><div></div><div>
Special Projects</div><ul><li>Participate in department or cross-functional projects as defined by</li></ul><div>
internal team goal or outside department needs.</div><div></div><div>
Deliverables</div><ul><li>Ensuring HCP agreements are in place and required compliance checks have been performed and documented in relevant systems.</li></ul></li></ul><div>
Your Profile:</div><ul><li><div>
Basic Qualifications</div></li><li><ul><li>BAIBS/BSc</li><li>1-year work experience in clinical trial operations or contract administration role</li></ul><div>
Preferred Qualifications</div><ul><li>Previous experience with supervisory or management responsibilities of clinical trial oversight or financial and payment oversight.</li><li>BAIBS/BSc in Finance or</li><li>Accounting</li><li>3 years&rsquo; work experience in clinical trial operations or contract administration role</li></ul></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>

Clinical Trial Consulting Ops Snr Associate

Edwards Lifesciences

<div><p>Make a meaningful difference to patients around the world. As a part of the Field Clinical Specialist team, you will be a critical part of delivering our patient focused innovations, partnering with clinical professionals, and training them on using our groundbreaking products. Your knowledge of working within the hospital ecosystem, combined with our in-depth training program, will help develop you into an Edwards subject matter expert, so you can play your own part in transforming patient lives.
</p><p></p><p>Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient&rsquo;s unmet clinical needs. It&rsquo;s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
</p><p></p><p><b><i>Note: this Clinical Specialist will support field cases for PASCAL (mitral repair device) in the local territory. Candidate based in Colorado CO or close surrounding metro area ideal.
</i></b></p><p></p><p><b>How you will make an impact:
</b></p><ul><li><p>Educate physicians on device handling, implantation and troubleshooting techniques related to the equipment required for device implants
</p></li><li><p>Coordinate one-on-one training sessions and in-service education programs in the hospital environment
</p></li><li><p>Provide medical staff with clinical instructions to support the full continuum of patient care
</p></li><li><p>Identify therapy adoption opportunities in collaboration with sales reps and managers in local geographies
</p></li><li><p>Serve as the designated expert on Edwards products by sharing your knowledge and training hospital staff
</p></li><li><p>Provide on-site, real-time guidance during clinical implants and proactively prepare contingency plans to address unforeseen occurrences
</p></li><li><p>Document procedural case observations for regulatory requirements and ongoing continuous improvement
</p></li><li><p>Collaborate with product development teams to provide feedback on device features and new device development
</p></li></ul><p></p><p><b>What you will need (Required):
</b></p><ul><li><p>Associate&rsquo;s Degree or relevant work experience
</p></li><li><p>A minimum of 5 years of related clinical or field experience required
</p></li><li><p>Experience with therapeutic implantable devices or interventional/surgical clinical care
</p></li><li><p><b>A willingness to travel up to 50% (regular car, air, overnight)
</b></p></li></ul><p></p><p><b>What else we look for (Preferred):
</b></p><ul><li><p>Experience in interventional cardiology/cardiac cath lab
</p></li><li><p>Clinical experience in one following specialties or similar specialities such as: CV Sonography (RDCS/RDS), CVOR / Cath Lab Nursing (NP/RN/BSN/MSN), Physician Assistant (PA-C), or Cardiovascular Technician (RCIS/CVT/RTR/RCES/CST)
</p></li><li><p>Interventional echo-navigation imaging expertise, specifically with 2D/3D TEE preferred
</p></li><li><p>MPR (multiplanar reconstruction) experience and CT-imaging experience big plus
</p></li><li><p>Experience in cardiac surgery procedures
</p></li><li><p>Clinical engineering experience from industry-related positions that support clinical development and clinical case support
</p></li><li><p>Strong knowledge in cardiovascular science and valvular heart disease processes
</p></li></ul><p>Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
</p><p></p><p>For Colorado, the base pay range for this position is $115,000 to $139,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
</p><p></p><p>E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
</p><p></p><p><b>COVID Vaccination Requirement
</b></p><p>Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.</p></div>

Field Clinical Specialist, Denver CO, TMTT

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