senior clinical research associate

AbbVie

<div><b>Company Description</b><p><b><br>
About AbbVie</b></p><p>
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.</p><b><br>
Job Description</b><p><br>
Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging advanced capabilities to drive industry leading performance.<br>
Partners with study teams, AbbVie internal R&amp;D stakeholders, investigators, and site staff for meaningful and effective engagements positioning AbbVie as the partner of choice in clinical trials.<br>
Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.</p><p><b>
Responsibilities:</b></p><p>
Considered as the Primary Sponsor Point of contact for the investigative site. Advanced level of competency or experience in providing contextual information on the clinical trials, connecting stakeholders to the investigative sites and strengthening Abbvie's positioning. Ability to motivate and align monitoring community through leadership and mentorship.</p><ul><li>
Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol, and patient treatment principles for the trial ensuring a trusted partnership. Able to support, guide, and mentor junior personnel on Site Management activities.</li><li>
Conducts site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.</li><li>
Superior understanding of site engagement and ability to customize site engagement strategy for assigned study/ies and critically apply new strategies as needed. Gather local/site insights and utilize site engagement tools to report/track progress and measure impact of that strategy.</li><li>
Superior level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Expert understanding to generate and ensure effective recruitment and retention techniques/plans based on the patient disease journey. Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.</li><li>
Possesses advanced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development. Supports local onboarding of more junior CRAs. Demonstrates ability to openly listen to and consider viewpoints to enhance outcomes.</li><li>
May participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by manager.</li><li>
Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues. Superior ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.</li><li>
Independently Identifies, evaluates and recommends new/potential investigators/sites on an on going basis demonstrating expert understanding and decision making. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.</li><li>
Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. Ensures audit and regulatory inspection readiness at assigned clinical site at all times. Manages investigator payments as per executed contract obligations, as applicable.</li></ul><p></p><ul><li><br>
<b>This is a remote position. Candidates must be based in MA and be willing to travel for site visits.</b></li></ul><b><br>
Qualifications</b><br>
<ul><li>
Education: Bachelor&rsquo;s degree or equivalent degree; health related preferred (e.g. Medical, Scientific, Nursing, Pharmacy).</li><li>
Minimum of 3 years of clinically related experience, of which a period of 2 years is preferable in independent clinical research monitoring of investigational drug or device trials in any therapeutic area. Familiar with risk‐based monitoring approach, onsite and offsite monitoring.</li><li>
Knowledge of appropriate therapeutic area indications with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials</li><li>
Superior knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.</li><li>
Demonstrate advanced communication skills and superior cross-functional collaboration skills among internal and external stakeholders.</li><li>
Demonstrate superior planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.</li><li>
Superior ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.</li><li>
Superior interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.</li><li>
Ability to independently use functional expertise, leverage critical thinking skills and apply good judgement to address clinical site issues</li><li>
Acts with integrity in accordance with AbbVie code of business conduct and leadership values. Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.</li></ul><br>
<b>
Additional Information</b><p><br>
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
</p><ul><li><p>The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at thetime of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographiclocation, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
</p></li><li><p>We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
</p></li><li><p>This job is eligible to participate in our short-term incentive programs.
</p></li></ul><p>Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company&rsquo;s sole and absolute discretion, consistent with applicable law.</p><div></div><p>
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.</p><p>
US &amp; Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html</p><p>
US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:</p><p>
https://www.abbvie.com/join-us/reasonable-accommodations.html</p></div>

Senior Clinical Research Associate

AtriCure, Inc.

AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure’s Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure’s AtriClip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure’s Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure’s cryoICE cryoSPHERE® probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.
<br><br>
We foster a culture of inclusion by embracing diverse experiences and individuals where everyone’s authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.
<br><br>
<b>POSITION SUMMARY:</b><br>
The Senior Clinical Research Associate (Sr. CRA) at AtriCure plays a vital role in the Clinical Affairs department, independently managing and overseeing site management and/or monitoring activities during clinical trial execution. This position requires a high level of autonomy and leadership, providing guidance to junior team members and ensuring compliance with regulatory standards and protocols. The Sr. CRA is instrumental in maintaining the integrity of clinical data and adapting to evolving study needs.
<br><br>
<b>ESSENTIAL FUNCTIONS OF THE POSITION:</b><br>
Site Management
<br><ul>
<li>Coordinate the collection and review of essential documents from clinical investigation sites in collaboration with study team personnel.</li>
<li>Conduct Site Qualification, Initiation, Interim and Close-Out training visits.</li>
<li>Facilitate required training sessions (e.g., EDC, Protocol, Device) and support site nomination and qualification processes.</li>
</ul>
Site Communications
<br><ul>
<li>Act as the primary point of contact for site communications and inquiries.</li>
<li>Liaise with clinical study management, field personnel, and CROs, addressing moderately complex protocol or study related issues as necessary.</li>
</ul>
Compliance
<br><ul>
<li>Ensure clinical study sites adhere to assigned protocols and regulatory standards, independently reviewing individual site compliance and addressing issues with study management.</li>
</ul>
Data Management
<br><ul>
<li>Review and analyze data for accuracy and completeness.</li>
<li>Lead the creation, management, and resolution of data queries for assigned sites</li>
<li>Support development of data cleaning reports and metrics in collaboration with data and operations management teams.</li>
</ul>
Monitoring
<br><ul>
<li>Conduct site monitoring visits (qualification, initiation, interim, and close-out) to ensure adherence to study procedures and regulatory requirements.</li>
<li>Assist in reviewing peer interim monitoring visit (IMV) reports.</li>
</ul>
Safety
<br><ul>
<li>Manage the processing of product complaints and adverse events, collaborating with safety specialists to gather materials for CEC meetings.</li>
</ul>
Study Management
<br><ul>
<li>Draft study-related materials, such as patient brochures and recruitment tools.</li>
<li>Support the coordination of activities with study-specific committees, vendor services, and core labs.</li>
</ul>
Leadership and Development
<br><ul>
<li>Provide mentorship and guidance to junior team members, fostering a collaborative environment.</li>
<li>Engage in continuous professional development and contribute to strategic project management activities.</li>
</ul>
Other Duties
<br><ul>
<li>Ensure appropriate translations for study documents and engage in global process improvement initiatives.</li>
<li>Mentor less experienced clinical team members and participate in core team activities.</li>
<li>Contribute to departmental SOPs and work instructions, driving revisions as necessary.</li>
</ul>
<b>ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:</b><br>
<ul>
<li>Regular and predictable work performance</li>
<li>Ability to work under fast-paced conditions</li>
<li>Ability to make decisions and use good judgement</li>
<li>Ability to prioritize various duties and multitask as required</li>
<li>Ability to successfully work with others</li>
<li>Additional duties as assigned</li>
</ul>
<b>BASIC QUALIFICATIONS:</b><br>
<ul>
<li>Bachelor’s degree with a minimum of 5 years of clinical research experience.</li>
<li>Must be bilingual in French and English.</li>
<li>Strong leadership, organizational, and communication skills with the ability to work independently and as part of a team.</li>
<li>Proficiency in Microsoft Office Suite and familiarity with clinical data management systems.</li>
<li>Willingness to travel between 10-75% of the time.</li>
</ul>
<b>OTHER REQUIREMENTS:</b><br>
<ul>
<li>Ability to regularly walk, sit, or stand as needed</li>
<li>Ability to occasionally bend and push/pull as needed</li>
</ul>
LI-KN1
<br><br>
AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 20 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria. To see a complete list of our benefits, please visit our careers website: https://www.atricure.com/careers-atricure/benefits. AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here https://www.e-verify.gov/ AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).

Senior Clinical Research Associate - Bilingual

Agilent Technologies

<div><h2 class="jobSectionHeader"><b>Job Description</b></h2><p></p><ul><li><p>
Performs all study monitoring visits and completes supporting visit reports, including applicable visits such as site/investigator qualification, site initiation, interim monitoring, remote monitoring, and close-out visits</p></li><li><p>
Trains investigator(s) and site staff on study protocol and all relevant study procedures</p></li><li><p>
Supports study start-up, conduct, and closeout activities. May assist in developing study related plans and documents including clinical protocol, clinical brochures/lFUs, development of CRFs, reviewing informed consent forms, monitoring plan, etc. May coordinate IRB/EC approvals</p></li><li><p>
Functions independently in the field and interacts professionally with all levels of medical and scientific professionals</p></li><li><p>
Identify early on any unsatisfactory results, operations or specific problems and take immediate action to appropriate groups including escalating and assisting in resolving any study related issues that arise during study conduct</p></li><li><p>
Assures adherence to GCP, study protocol, procedures, all applicable requirements, and regulations throughout the study monitoring visits. Responsible for implementing and maintaining the effectiveness of the quality system</p></li><li><p>
Collect and review site regulatory and essential documents for accuracy and completion. Maintain the study Trial Master File (TMF)/or eTMF and ensure the Investigator Site Files (ISFs) are current and maintained</p></li><li><p>
Perform Source Data Verification (SDV) and data cleaning in accordance with study monitoring plan. Reviewing all study logs and documentation ensuring audit trail and chain of custody is maintained</p></li><li><p>
Performs Investigation Use Only (IUO) or Research Use Only (RUO) inventory and accountability, in accordance with study monitoring plan. Facilitates return or destruction of any unused IUO/RUO material as required</p></li><li><p>
 Serve as the primary point of contact for assigned sites and works with sites to resolve data queries and monitoring findings</p></li><li><p>
Maintains accurate and timely communications with sites and ensures records are filed in TMF/ISF</p></li><li><p>
Ensures TMF/ISF is audit ready. Assists with site audit(s) and site quality management activities, as needed. Tracks site progress against contractual agreements</p></li><li><p>
Contribute to organizational and departmental process development, improvement, and implementation</p></li></ul><p><b><br>
In addition to the primary, the Senior CRA will also be expected to take on the following responsibilities:</b></p><p></p><ul><li><p>
Assist and/or develop study-related plans and documents including clinical protocol, clinical brochures/lFUs, development of CRFs, informed consent forms, monitoring plan, etc.</p></li><li><p>
Assist in training new CRA staff by supporting remote monitoring, co-monitoring and/or mentoring</p></li><li><p>
Assist the project management team in identifying risks in study execution at study sites, implement mitigations, monitoring outcomes, and communicate observations</p></li><li><p>
Demonstrate an ability to influence others, especially study site staff, to achieve positive results and collaboration through diplomacy and respect for others, appropriate prioritization and facilitation of the decision-making process</p></li><li><p>
Demonstrate a high degree of competence in clinical research with prior exposure to all aspects of clinical study and functions at a proficient level of independence with a significant degree of autonomy in conducting clinical research</p></li><li><p>
May serve as Lead CRA or Lead monitor for assigned studies</p></li><li><p>
Works closely with other assigned CRAs to track monitoring deliverables and metrics in accordance with the study monitoring plan</p></li><li><p>
May actively participate as a member of the cross-functional project team</p></li></ul><p></p><h2 class="jobSectionHeader"><b>
Qualifications</b></h2><p></p><ul><li><p>
Bachelor's degree in biological sciences or medical specialty or higher, or equivalent credentials</p></li><li><p>
For Senior CRA: 5+ years direct clinical research experience at a sponsor, device manufacturer, IVD, companion diagnostics as a CRA/study monitor, or equivalent experience</p></li><li><p>
Experience with Electronic Data Capture (EDC) systems and eTMF systems</p></li><li><p>
Molecular diagnostic, medical device, in vitro diagnostic (IVD), companion diagnostics, oncology and/or pathology experience</p></li><li><p>
Previous experience with Next Generation Sequencing (NGS), lmmunohistochemistry (IHC), and/or pathology</p></li><li><p>
Knowledge of International Council for Harmonisation (ICH)/GCP guidelines, 21 CFR (Code of Federal Regulations) part 812 (lnvestigational Device Exemption) (IDE)), and monitoring procedures/best practices (ICH E6(R2))</p></li><li><p>
Demonstrating strong written and verbal communication skills and presentation skills</p></li><li><p>
Track record demonstrating strong organizational and problem-solving skills</p></li><li><p>
Track record demonstrating a strong work ethic and ability to deliver tasks on time</p></li><li><p>
Proficient with Microsoft Office Suite including automation tools</p></li></ul><p></p><p><b><br>
Additional Details</b></p><p></p>
This job has a full time weekly schedule. It includes the option to work remotely. Applications for this job will be accepted until at least March 23, 2026 or until the job is no longer posted.<p></p>
The full-time equivalent pay range for this position is $80,800.00 - $151,500.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations<p></p>
Agilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_posting@agilent.com or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.<p></p><h2 class="jobSectionHeader"><b>
Travel Required:
</b></h2>25% of the Time<p></p><h2 class="jobSectionHeader"><b>
Shift:
</b></h2>Day<p></p><h2 class="jobSectionHeader"><b>
Duration:
</b></h2>No End Date<p></p><h2 class="jobSectionHeader"><b>
Job Function:
</b></h2>Medical/Clinical</div>

Senior Clinical Research Associate (CRA)

Everest Clinical Research

<div><p>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.</p>
<p>
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.</p>
<p>
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.</p>
<p>
Quality is our backbone, customer-focus is our tradition, flexibility is our strength&hellip;that&rsquo;s us&hellip;that&rsquo;s Everest.</p>
<p>
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 <b>Senior Clinical Research Associate (Pain/Oncology/CNS Therapeutic Areas)</b>.</p>
<p><b>
Key Accountabilities:</b></p>
<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>
<p><b>Qualifications and Experience:</b></p>
<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>
<p>To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.ecrscorp.com</p>
<p>
Estimated Salary Range: $ 125,000 - 145,000.</p>
<p>
We thank all interested applicants, however, only those selected for an interview will be contacted.</p>
<p>
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.</p></div>

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

CTI Clinical Trial Services

<div><p>Responsible for project activities associated with monitoring functions of phase I through phase IV clinical research studies and Real World Evidence (RWE) studies, while continuing to develop knowledge of drug development process, International Council for Harmonisation (ICH) / Good Clinical Practice (GCP), and relevant regulations. Performs management of study site activities in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs).</p>
<p><b>
 What you'll do:</b></p>
<ul>
<li>Serve as the main CTI contact for assigned study sites</li>
<li>Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in the Monitoring Plan while adhering to all applicable regulatory requirements, SOPs, and ICH GCP</li>
<li>Assist with study start-up activities, including feasibility, pre-study activities, and site selection</li>
<li>Collect, review, and track essential/regulatory documents</li>
<li>Participate in and complete all general and study-specific training as required</li>
<li>Participate in investigator, client, and project team meetings</li>
<li>Create and implement subject enrollment strategies for assigned study sites</li>
<li>Ensure proper storage, dispensation, and accountability of all Investigational Product (IP) and trial-related materials</li>
<li>Perform site management activities and provide ongoing updates of site status to the Clinical Project Manager</li>
<li>Conduct remote monitoring and complete the related activities in accordance with study study-specific Monitoring Plan</li>
</ul><ul><li>Utilize systems and reports to track subject status, subject case report form (CRF) retrieval/source document review (SDV), regulatory documents, and IP</li>
<li>Assist with project-specific activities as a member of the Project Team</li>
<li>May support in the development of CRFs and other study-related documents (subject worksheets, Monitoring Plan, etc.)</li>
<li>May support in the translation, customization, and review of Patient Information sheet and Informed Consent, protocol synopsis, and other study-applicable documents as per required procedures</li>
<li>Where applicable, provide support to the Regulatory Affairs Study Start-up Team in the preparation or
<p>
revision of documentation for submission to Ethics Committee(s), Institutions' Ethics Committees, Regulatory Authorities, Competent Authorities or Institutions Administration Boards, and follow up on the evaluation process until approval is available. Provide regular updates to the Sponsor/ Client</p>
</li>
<li><p>Assist in preparing and coordinating Investigator and client meetings, and attend meetings as necessary</p>
</li>
<li>Liaise with Clinical Data Management for data cleaning activities</li>
<li>Identify site issues and implement corrective actions or escalate as appropriate</li>
<li>Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans</li>
<li>Where applicable, support in contract negotiation with study sites, Investigator payments, and tracking of site payments</li>
</ul>
<p><b>What You'll Bring:</b></p>
<ul>
<li>At least 1 year of clinical trial monitoring experience or equivalent experience as determined by CTI Management and Human Resources</li>
<li>Bachelor's Degree or higher in an allied health field such as nursing, pharmacy, or health / natural science, or RN with an Associate's Degree, or 3-year Nursing Diploma with at least 2 years clinical nursing experience, or equivalent experience as determined by CTI Management and Human Resources</li>
<li>Previous experience in conducting clinical research studies in a hospital setting, a pharmaceutical company, or a CRO</li>
<li>Demonstrated successful performance in a CRA position with a minimum of 1 year of on-site monitoring experience preferred</li>
</ul>
<p><b>Why CTI?</b></p>
<ul>
<li><b>Advance Your Career</b> &ndash; We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.</li>
<li><b>Join an Award-Winning and Valued Team </b>&ndash; We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work-from-home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.</li>
<li><b>Make a Lasting Impact </b>&ndash; We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.</li>
</ul>
<p><b>Important Note</b><br>
In light of the recent increase in hiring scams, if you're selected to move on to the next phase of our hiring process, a member of our team will reach out to you directly from an <b>@ctifacts.com</b> email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.
<br>
<br>
<b>Please Note</b></p>
<ul>
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Senior Clinical Research Associate (level dependent on experience)

IQVIA

<div><div><div>Bloomington, United States of America | Full time | Field-based | R1535029</div><div><div><b>
Job available in additional locations</b></div></div></div><p></p><div><div><b><br>
IQVIA is hiring Senior Clinical Research Associate 1 </b>with experience in either oncology, cardiovascular, renal, metabolic, CNS, Obesity (GLP-1), diabetes, GI, MASH/NASH, dermatology, or respiratory:</div><div><b>
Job Overview:
</b></div><div>Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.</div><div><b>
Key Responsibilities:
</b></div><ul><li>Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.</li><li>Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.</li><li>Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.</li><li>Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.</li><li>Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.</li><li>Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.</li><li>Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.</li></ul><div>
&bull; Collaborate and liaise with study team members for project execution support as appropriate. Responsibilities Essential Functions &bull; If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.</div><ul><li>If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.</li></ul><div><b>
Qualifications:</b></div><ul><li>Bachelor's Degree in scientific discipline or health care preferred.</li><li>Requires at least 2 years of year of on-site monitoring experience.</li><li>Equivalent combination of education, training and experience may be accepted in lieu of degree.</li><li>Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.</li><li>Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.</li><li>Good therapeutic and protocol knowledge as provided in company training.</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 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 $101,600.00 - $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>

Sr. Clinical Research Associate, IQVIA

<div><div><div>South Bend, United States of America | Full time | Field-based | R1535029</div><div><div><b>
Job available in additional locations</b></div></div></div><p></p><div><div><b><br>
IQVIA is hiring Senior Clinical Research Associate 1 </b>with experience in either oncology, cardiovascular, renal, metabolic, CNS, Obesity (GLP-1), diabetes, GI, MASH/NASH, dermatology, or respiratory:</div><div><b>
Job Overview:
</b></div><div>Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.</div><div><b>
Key Responsibilities:
</b></div><ul><li>Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.</li><li>Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.</li><li>Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.</li><li>Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.</li><li>Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.</li><li>Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.</li><li>Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.</li></ul><div>
&bull; Collaborate and liaise with study team members for project execution support as appropriate. Responsibilities Essential Functions &bull; If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.</div><ul><li>If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.</li></ul><div><b>
Qualifications:</b></div><ul><li>Bachelor's Degree in scientific discipline or health care preferred.</li><li>Requires at least 2 years of year of on-site monitoring experience.</li><li>Equivalent combination of education, training and experience may be accepted in lieu of degree.</li><li>Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.</li><li>Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.</li><li>Good therapeutic and protocol knowledge as provided in company training.</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 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 $101,600.00 - $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>

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