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clinical research associate

IQVIA

<div><div><div>Indianapolis, United States of America | Full time | Field-based | R1530895</div><div><div><b>
Job available in additional locations</b></div></div></div><p></p><div><div><i><br>
At IQVIA Biotech, we partner with visionary biotech companies to transform innovation into patient impact. With dedicated teams, deep therapeutic expertise, and a biotech-tailored delivery model, we accelerate clinical development from early phase through global registrational studies.</i></div><div>
We&rsquo;re seeking an experienced Clinical Research Associate with <b><i>1-3 years of onsite monitoring</i></b> to oversee clinical trial sites and ensure high‑quality study execution. In this role, you&rsquo;ll monitor study activity, support site teams, and ensure adherence to protocols, regulations, and sponsor expectations. Preference would be to have oncology experience but open to other therapeutic areas.</div><div><h3 class="jobSectionHeader"><b>
Key Responsibilities</b></h3><ul><li>
Conduct site visits (selection, initiation, monitoring, and close‑out) in compliance with GCP, ICH, and study requirements.</li><li>
Partner with sites to drive patient recruitment and meet study enrollment goals.</li><li>
Provide study protocol and procedure training to site staff and maintain consistent communication to support study progress.</li><li>
Assess site performance, data quality, and regulatory compliance; escalate issues when needed.</li><li>
Track study milestones including submissions, approvals, enrollment, data entry, and query resolution.</li><li>
Ensure accurate and complete maintenance of site documentation and Trial Master File materials.</li><li>
Prepare monitoring reports, follow‑up letters, and other required documentation.</li><li>
Collaborate closely with the study team and provide support with start‑up activities as applicable.</li><li>
(If applicable) Support site‑level recruitment planning and financial management.</li></ul><h3 class="jobSectionHeader"><b>
Qualifications</b></h3><ul><li>
Bachelor&rsquo;s degree in a scientific or healthcare field (or equivalent experience).</li><li>
Minimum 1 year of on‑site clinical monitoring experience.</li><li>
Strong knowledge of GCP/ICH guidelines and clinical research regulatory requirements.</li><li>
Proficiency with Microsoft Office and digital tools (laptop, mobile devices).</li><li>
Excellent communication, organization, and problem‑solving skills.</li><li>
Ability to build strong working relationships with study teams, site staff, and sponsors.</li></ul></div><div>
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com</div><div>
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe</div><div>
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.</div>
The potential base pay range for this role, when annualized, is $71,900.00 - $169,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.</div></div><div></div>

Clinical Research Associate

<div><div><div>Indianapolis, 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>
 <em>
  <strong>
   IQVIA Biotech is now hiring for CRA 1 with a minimum of 6 months of on-site monitoring. Must have experience monitoring in oncology solid tumor.
   <br/>
   <br/>
  </strong>
 </em>
 <em>
  IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience, we offer agile, therapeutically aligned solutions and trusted partnerships that help bring breakthrough treatments to patients faster.
  <br/>
  <br/>
 </em>
 <strong>
  Job Overview
  <br/>
  <br/>
 </strong>
 The Clinical Research Associate I (CRA I) plays a key role in supporting the successful conduct of clinical research studies by performing site monitoring and site management activities. In this position, you will ensure that assigned study sites conduct trials in compliance with the protocol, applicable regulations, Good Clinical Practice (GCP), and ICH guidelines. This role is essential in protecting patient safety, ensuring high‑quality clinical data, and maintaining study integrity.
 <br/>
 <br/>
 <strong>
  Key Responsibilities
  <br/>
  <br/>
 </strong>
 As a CRA I, you will conduct various types of monitoring visits&mdash;including site selection, initiation, routine monitoring, and close‑out visits&mdash;to evaluate the quality and integrity of site practices. You will verify that study activities are performed according to regulatory requirements and sponsor expectations, escalating quality concerns as necessary. During these visits, you will review essential documents, assess protocol adherence, oversee data entry and query resolution, and ensure maintenance of both the Trial Master File (TMF) and the Investigator Site File (ISF).
 <br/>
 <br/>
 A central part of this role involves building and maintaining strong communication with investigative sites. You will provide protocol training, set expectations, address site‑level challenges, and support recruitment planning to help sites meet enrollment targets. You will also collaborate closely with internal project teams to ensure cohesive study execution and may contribute to site-level financial processes or start‑up activities based on study needs.
 <br/>
 <br/>
 Accurate and timely documentation is critical. The CRA I prepare detailed monitoring visit reports, follow‑up letters, and all required study documentation to ensure audit readiness and transparent oversight. The ability to manage multiple tasks, prioritize effectively, and work independently while maintaining productive team relationships is essential for success.
 <br/>
 <br/>
 <strong>
  Qualifications
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Bachelor&rsquo;s degree required; a scientific or healthcare discipline is preferred.
  </li>
  <li>
   6 months &ndash;2 years of relevant experience, with equivalent combinations of education, training, or completion of a CRA training program considered.
  </li>
  <li>
   Basic knowledge of clinical research regulations (GCP/ICH).
  </li>
  <li>
   Ability to travel as required by the project.
   <br/>
   <br/>
  </li>
 </ul>
 IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
 <br/>
 <br/>
 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
 <br/>
 <br/>
 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.
 <br/>
 <br/>
 The potential base pay range for this role, when annualized, is $71,900.00 - $119,900.00. 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>


CRA 1, IQVIA Biotech

Indiana University Health

<div><div><div><div><h1 class="jobSectionHeader"><b>Clinical Research Nurse</b></h1>
</div></div><div></div><div><h2 class="jobSectionHeader"><b>Job Description</b></h2>
<div><p><b>Overview</b>
</p><p><b><i>Location: </i></b><i>Onsite at</i><b><i> </i></b><i>Methodist Hospital with some travel to University, North, West &amp; Fishers Hospitals required</i></p><p><b><i>
Position: </i></b><i>Clinical Nurse Research</i></p><p><b><i>
Shift: </i></b><i>Monday &ndash; Friday</i></p><p></p><p><b><i><br>
IU Health is Indiana's #1 Healthcare system with a comprehensive network of 16 hospitals and over 34,000 dedicated team members. If you are seeking a dynamic and rewarding career opportunity that enables you to utilize your expertise to improve the lives of patients and their families, IU Health invites you to explore our Clinical Research Team!</i></b></p><p><b><i>
Job Summary:</i></b></p><p><i>
We are seeking a highly skilled and motivated Clinical Research Nurse to join our team on a full-time basis, working Monday through Friday, day shift, this role is base at Methodist Hospital with some travel to University, North, West &amp; Fishers Hospitals required. As a Clinical Research Nurse, you will collaborate with a multidisciplinary team to coordinate clinical trials and provide exceptional patient care.</i></p><p><b><i>
Position Overview:</i></b></p><p><i>
The clinical research team is made up of nurses, coordinators and research assistants working together to provide clinical research opportunities to our IU Health patients. The team supports over eighty clinical trials in both the inpatient and outpatient settings. These studies serve patients in specialties such as cardiology and CV surgery, pulmonology, transplant, neurology, GI, endocrinology, and infectious diseases.</i></p><p><i>
The research nurse position allows the team member to utilize their nursing knowledge and skills through the coordination of clinical trials. The clinical research nurse achieves this by coordinating regulatory aspects of clinical trials, collaborating with team members and key stake holders both within and outside of IU Health, screening and enrolling patients in clinical trials and carrying out study visits. Key attributes for this position include a team-oriented attitude, strong organizational and time management skills, and an eagerness to learn new things.</i></p><p><b><i>
Qualifications/Experience:</i></b></p><ul><li><i>
Requires an Associates of Nursing (ASN); Bachelors of Nursing (BSN) preferred.</i></li><li><i>
Requires an active Registered Nurse (RN) license in the state of Indiana or an active Nurse Licensure Compact (NLC) RN license.</i></li><li><i>
Requires that the RN has graduated from a nationally accredited nursing program.</i></li><li><i>
Requires 5-7 years of relevant experience.</i></li><li><i>
Requires Basic Life Support certification through the AHA.</i></li><li><i>
Other advanced life support certifications may be required per unit/department specialty according to patient care policies.</i></li><li><i>
Requires knowledge of FDA regulations to govern the conduct of research trials.</i></li><li><i>
Requires ability to perform physical assessment of patients.</i></li><li><i>
Requires phlebotomy skills to draw blood; start IVs.</i></li><li><i>
Requires proficiency in Microsoft Office and applications.</i></li><li><i>
ICU experience preferred, but not required</i></li></ul><p></p><p><b><i><br>
Why Join IU Health?</i></b></p><p><i>
As Indiana's largest and most comprehensive healthcare system, and the #1 ranked healthcare system in Indiana, we offer a range of benefits and perks, including:</i></p><ul><li><i>
401(K) retirement savings with employer match</i></li><li><i>
Tuition reimbursement</i></li><li><i>
Student loan forgiveness program through a government initiative</i></li><li><i>
Employee Assistance Program with confidential counseling services</i></li><li><i>
Healthy Results - A wellness program that rewards participation and contributes to a biweekly financial incentive</i></li></ul><p><b><i>
To learn more about our benefits, visit: [careers.iuhealth.org/pages/benefits-designed-for-you](https://careers.iuhealth.org/pages/benefits-designed-for-you)</i></b></p><br>
</div><p></p><div><p>We are an equal opportunity employer. IU Health does not discriminate on the basis of race, color, religion, sex, sexual orientation, age, disability, genetic information, veteran status, national origin, gender identity and/or expression, marital status or any other characteristic protected by federal, state or local law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.</p>
</div></div></div><div></div><div><div><div><p>Indiana University Health is Indiana&rsquo;s most comprehensive health system, with 15 hospitals and nearly 40,000 team members serving Hoosiers across the state. Our partnership with the Indiana University School of Medicine gives our team members access to the very latest science and the very best training, advancing care for all. We&rsquo;re looking for team members who share the things that matter most to us. People who are inspired by challenging and meaningful work for the good of every patient. People who are compassionate and serve with a purpose. People who aspire to excellence every day. People who are always ready to apply themselves.</p></div></div></div></div>

Clinical Research Nurse

Eli Lilly

<div><p>At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We&rsquo;re looking for people who are determined to make life better for people around the world.</p><p></p><p>
The Clinical Research Physician (CRP) in GPS Medical has responsibilities associated with the development, management, execution, and oversight of all aspects of the safety program for one (or more) asset(s) throughout the product(s') life cycle. This individual plays a major role in coordinating technical functions within GPS to facilitate these responsibilities. The individual is accountable for collaborative contributions and partnership with the integrated development or product team to deliver on these safety commitments while demonstrating GPS expertise and leadership.</p><p></p><p>
The CRP is the Lilly GPS Medical representative for both internal and external stakeholders regarding a product or developmental therapeutic agent, interacting as prescribed in corporate guidelines, standards, and policies. Individualized responsibilities for a particular product or project will be discussed and agreed at an individual level.</p><p></p><h1 class="jobSectionHeader"><b>
Primary Responsibilities</b></h1><p><i>
This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Not all listed responsibilities will be applicable to all GPS Medical CRP roles. Consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.</i></p><p></p><h2 class="jobSectionHeader"><b>
1. Key GPS Medical Activities and Safety Oversight</b></h2><ul><li>
Provides GPS Medical leadership and ensures proactive pharmacovigilance (PV) for assigned product(s):<ul><li>
In early phase development, performs and/or contributes to medical review of individual case safety reports for completeness and accuracy, providing company causality assessment and requests for follow up, if needed.</li><li>
Provides medical oversight of surveillance activities, safety signal decisions and risk management actions to be taken, including communication and/or escalation to appropriate internal or external stakeholders (e.g., GPS leadership, governance committees, development teams, Regulators)</li><li>
Monitors various safety activities for impact to Core Safety Information and Core Risk Minimization activities</li><li>
Builds collaborative working relationships to ensure full cooperation; guides effective and efficient drug development, and ensures high-quality medical evaluation of safety data</li><li>
Responsible for the oversight and actions related to regulatory queries on safety-related topics</li></ul></li><li>
Acts as the GPS Medical lead at the time of acquisitions and integrations of new companies/assets, partnering with internal and external stakeholders to ensure seamless continuity of safety surveillance activities.</li><li>
Demonstrates advanced knowledge of safety concepts, per ICH, US and international regulation/guidelines and GxP.</li><li>
Synthesizes complex data into actionable insights and translates technical issues into strategic discussions</li></ul><p></p><h2 class="jobSectionHeader"><b>
2. Acts as the Lilly GPS Medical Representative for Both Internal and External Stakeholders</b></h2><p>
Interacting as prescribed in corporate guidelines and policies.</p><ul><li>
Builds strong relationships with key stakeholders, representing and championing the role of safety in the organization (including):<ul><li>
Product Team Leaders and Business Unit Leadership</li><li>
Regulatory (including Device and CMC regulatory)</li><li>
Affiliate Medical Leadership/Clinical Research Physicians</li><li>
COE and Discovery and Clinical Research</li><li>
External Opinion Leaders</li></ul></li><li>
Reviews and comments on external regulatory policy and trends affecting Global Patient Safety.</li><li>
Represents GPS Medical in inspection and audit activities for assigned program(s)</li><li>
May serve on safety advisory hub committees and/or consultative cross-functional bodies providing input and guidance to clinical development teams on select safety topics</li><li>
May serve as a member of the Quality-GPS (AE/PC and Device) safety surveillance teams evaluating aggregate product complaint/adverse event data for potential manufacturing quality related safety signals</li></ul><p></p><h2 class="jobSectionHeader"><b>
3. Product Safety Assessment</b></h2><ul><li>
Provide the sound and timely medical assessment decision making for the safety questions based on current medical and scientific data in collaboration with cross-functional partners for the following:<ul><li>
Product Safety Assessments (PSAs), Health Hazard Evaluations (HHEs), and other risk assessment documentation</li><li>
Device design, development, risk management, and periodic reporting</li><li>
CMC development, manufacturing changes, CMC submissions and CMC regulatory requests</li><li>
Company anticounterfeiting activities, product shortage evaluations, quality triage escalation activities and regulatory reporting.</li></ul></li><li>
Provide clinical evaluation of individual adverse events for possible manufacturing-related root cause for Lilly products</li><li>
Responsible for appropriate implementation of PSA/HHE process with manufacturing and/or marketing partners.</li><li>
Prepare medical complaints in response to signals identified during AE/PC and Device Surveillance.</li><li>
Review and approve/reject manufacturing investigation results in response to medical complaints, including escalation as needed for any identified manufacturing related safety issues.</li><li>
Proactive monitoring to evaluate for unanticipated safety impacts related to deviations addressed by HHEs</li></ul><p></p><h2 class="jobSectionHeader"><b>
4. People Management</b></h2><ul><li>
Foster and support a collaborative working environment that maintains a Team Lilly culture focused on inclusion, innovation, acceleration, and delivery</li><li>
Recruit, mentor, develop, and retain top clinical, scientific, and drug development talent, including clinical research physicians, clinical research scientists, and pharmacoepidemiologists.</li><li>
Assures staff comply with company policies and procedures</li></ul><p></p><h2 class="jobSectionHeader"><b>
5. Understand and Support the QPPV Role</b></h2><ul><li>
Understanding the roles and responsibilities of the European Union Qualified Person (QPPV).</li><li>
Ensure support is provided to enable the Qualified Person to fulfill all the Qualified Person legal responsibilities.</li></ul><p></p><h2 class="jobSectionHeader"><b>
6. Training, Coaching, Mentoring</b></h2><ul><li>
Provide training, coaching and mentorship demonstrating effective PV strategies and sharing experience and knowledge to further advance the goals of the GPS department and wider enterprise.</li><li>
Maintain compliance with Lilly Red Book and corporate policies, Lilly Research Laboratories and Global Patient Safety curriculum.</li><li>
Maintaining compliance with the Lilly Corporate Integrity Agreement.</li></ul><p></p><h2 class="jobSectionHeader"><b>
7. Global Path Job Criteria</b></h2><p>
A Clinical Research Physician, GPS Medical is expected to meet the criteria as outlined in the global path job criteria for the appropriate R path levels.</p><ul><li>
For each level on every global path, there is a consistent set of job criteria which includes functional and technical expertise, decision making, influence, and problem solving.</li></ul><p></p><h1 class="jobSectionHeader"><b>
Minimum Qualification Requirements</b></h1><ul><li>
Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring.</li><li>
US trained physicians must have achieved board eligibility or certification. Foreign medical graduates (in US based jobs) who are not US board eligible or certified may be hired directly for employment in the US at the discretion of the Chief Medical Officer.</li><li>
Non-US trained physicians must have completed education and training at a medical school that meets the minimum requirements substantially equivalent to the requirements of medical schools accredited by the Liaison Committee on Medical Education (LCME).</li><li>
Minimum 5+ years' experience in the pharmaceutical industry or clinical care setting.</li></ul><p></p><h1 class="jobSectionHeader"><b>
Other Information/Additional Preferences</b></h1><ul><li>
Oncology/Hematology preferred</li><li>
Clinical development or pharmacovigilance or medical affairs experience preferred</li><li>
Knowledge of drug development process</li><li>
Fluent in English with highly effective written and verbal communication skills</li><li>
Strong clinical/diagnostic skills</li><li>
Excellent interpersonal, organizational and negotiation skills</li><li>
Ability to work on multiple projects and function effectively in a fast-paced matrixed environment</li><li>
Ability to prioritize tasks and shift priorities rapidly to meet tight deadlines</li><li>
Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment</li><li>
Excellent teamwork skills</li><li>
Willing to engage in domestic and international travel to the degree appropriate to support the business of the team</li><li>
Knowledge of global pharmacovigilance guidelines, guidances, and regulations (EMA, FDA, etc.) relevant to the activities and responsibilities described above</li><li>
Strategic thinking</li><li>
Demonstrated success in implementing projects and/or innovating</li><li>
Receptive, engaging, and impactful contributor</li><li>
Prior experience in clinical trials preferred; academic and/or industry.</li></ul><p>
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.</p><p></p><p>
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.</p><p><br>
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women&rsquo;s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.</p><p></p><p>
Actual compensation will depend on a candidate&rsquo;s education, experience, skills, and geographic location. The anticipated wage for this position is</p>
$198,000 - $356,400<p></p><p>
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly&rsquo;s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.</p><p></p><p>
#WeAreLilly</p></div>

Clinical Research Physician, GPS Medical

DM Clinical Research

<div><p>The <b>Clinical Research Coordinator II</b> will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The <b>CRC II</b> will also ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis.</p><p><br>
</p><p><br>
<b>DUTIES &amp; RESPONSIBILITIES</b><br>
1. Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis.<br>
2. Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to:</p><ul><li>
a. Sponsor-provided and IRB-approved Protocol Training</li><li>
b. All relevant Protocol Amendments Training</li><li>
c. Any study-specific Manuals Training, as applicable</li><li>
d. Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training.</li></ul><p>
3. Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner.<br>
4. Adherence to ALCOA-C Standards with all the relevant clinical trial documentation.<br>
5. Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations.<br>
6. Demonstration of appropriate and timely follow-up on the action items, at their respective sites.<br>
7. Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols.<br>
8. Liaising with the Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols.<br>
9. Demonstrating adherence and compliance to the assigned protocols at their respective site(s).<br>
10. Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s)<br>
11. Maintaining a working knowledge of the recruitment and retention process for their assigned protocol(s) at their respective site(s).<br>
12. Demonstrating visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s)<br>
13. Maintaining a working knowledge of the most recent versions of the Study Protocols, Informed consents, Study Manuals, and all the other relevant study-related documents that are utilized and implemented for the assigned protocols at their respective site(s).<br>
14. Oversee reporting of all Adverse and Serious Adverse Events and any other relevant Safety Information to the appropriate authorities per internal company guidelines, Sponsor, IRB, and ICH-GCP Guidelines.<br>
15. Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations.<br>
16. Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s).<br>
17. Being prepared for and available at all required company meetings.<br>
18. Submitting required administrative paperwork per company timelines.<br>
19. Occasionally attending out-of-town Investigator Meetings<br>
20. Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives<br>
21. Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent<br>
22. Facilitate effective communication between patients, healthcare providers, and research staff<br>
23. Any other matters as assigned by management.</p><p><b><br>
KNOWLEDGE &amp; EXPERIENCE</b></p><p><b><br>
Education:</b></p><ul><li>
High School Diploma or equivalent required; Bachelor's degree preferred</li><li>
Foreign Medical Graduates preferred</li></ul><p><b>
Experience:</b></p><ul><li>
At least 2 years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting.</li></ul><p><b>
Credentials:</b></p><ul><li>
ACRP or equivalent certification is preferred</li></ul><p><b>
Knowledge and Skills:</b></p><ul><li>
Be an energetic, go-getter who is detail-oriented and can multi-task.</li><li>
Be goals-driven while continuously maintaining quality.</li><li>
Proficient communication and comprehension skills both verbal and written in the English language are required.</li><li>
Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.</li></ul></div><p></p>

Clinical Research Coordinator II

TRIMEDX

<div><div>If you are wondering what makes TRIMEDX different, it's that all of our associates share in a common purpose of serving clients, patients, communities, and each other with equal measures of care and performance.</div><ul><li>
Everyone is focused on serving the customer and we do that by collaborating and supporting each other</li><li>
Associates look forward to coming to work each day</li><li>
Every associate matters and makes a difference</li></ul><div></div><div>
It is truly a culture like no other &mdash; We hope you will join our team! Find out more about our company and culture <div>here</div>.</div><div></div><div>
Summary</div><div>
Aligned with the TRIMEDX Vision, Mission and Values, the primary role of a Cyber Field Services Specialist is to support the operations of the Clinical Engineering Department with regards to production medical equipment IT systems and various Connectable &amp; Connected Device Inventory (CDI) projects. These operations entail responding to and supporting with technical expertise Client driven integration projects, medical device network configurations, connected device inventory management, service and repair requests, identifying fault conditions and remediating if capable, or contacting and teaming with the Client Information Technology Department resources to resolve issues. This individual will utilize downtime plans, logistics, and training to support the operational data workflows of the integrated medical devices and the production environment. The Cyber Field Services Specialist will ensure clinical equipment systems are fully inventoried, interfaced and/or integrated with various information systems in a consistent dependable manner, as determined by the Client&rsquo;s Information Technology Department, in accordance with conventional networking and security practices, the Medical Equipment Management Plan and the TRIMEDX Clinical Engineering Program policies and procedures.</div><div></div><div>
Responsibilities</div><div>
Medical Device Integration Service and Support (50%)</div><ul><li>
Support, monitor and manage the Connected Device Inventory.</li><li>
Provide professional expertise, guidance and assistance in the area of Clinical Engineering-IT (CE CYBER) Systems and CDI.</li><li>
Establish themselves as the expert for the Clinical Engineering Department related to networked and/or integrated medical devices and/or systems.</li><li>
Promote uniform maintenance and repairs on production medical device systems across the Client&rsquo;s healthcare enterprise.</li><li>
Monitor, service and/or support clinical equipment that utilizes networking technologies and/or Unix or Windows based controllers.</li><li>
Respond to CDI trouble calls pertaining to data flow issues from customers.</li><li>
Troubleshoot medical equipment and/or MDI hardware and software to ensure data connections.</li><li>
Sets-up and configure of CDI interface hardware for use in the production CDI environment.</li><li>
Verify proper data flow conditions on the CDI network.</li><li>
Provide remote support for network issues and escalate issues appropriately to CE, HIT and/or vendors.</li><li>
Record activities related to maintenance, support and project activities in the Clinical Asset Maintenance and Management System (RSQ).</li><li>
Work with vendors on hardware and software patch implementation for medical equipment per TRIMEDX operating policies and procedures.</li><li>
Work with Client IT and various medical device and software vendors to lab test solutions prior to these solutions being put into the production environment.</li><li>
Provide training to Clinical Engineering associates on customized configuration and maintenance solutions developed for reintroducing integrated equipment back into the environment after repair.</li><li>
Monitors and evaluate proposed software revisions to medical equipment systems and actively track and ensure that systems being upgraded.</li><li>
Act as a System Administrator in partnership with Client IT and Clinical teams for medical equipment systems.</li><li>
Perform all duties related to this position as they are needed.</li></ul><div></div><div>
Project and Program Support (25%)</div><ul><li>
Responsible for the inventory, planning, maintenance and management of LAN/WAN-based and integrated medical equipment network devices.</li><li>
Collaborate and/or report out to the enterprise TRIMEDX CE CYBER program.</li><li>
Ensure the Clinical Engineering program and associates are capable of and maintain the connected device inventory with information related to clinical equipment in TRIMEDX&rsquo;s RSQ platform including, but not limited to, IP addresses, MAC addresses, AE titles, OS information, firmware versions, application versions, security attributes, equipment criticality and recovery information.</li><li>
Serve as Clinical Engineering project management representative for implementation of clinical equipment requiring network connectivity, interface configurations, and/or CDI. Helps to prepare project timelines, milestones and establishing Clinical Engineering roles and responsibilities. Works directly with vendors and all levels of management and support staff for scheduling and coordination to ensure adherence to established timelines.</li><li>
Provide timely advice to Clinical Engineering management regarding procedure changes required to maintain system and equipment stability.</li><li>
Develop service documentation, knowledge articles and/or instruction manuals for the support of integrated medical devices. Provides technical instruction &amp; training to others as needed or required.</li><li>
Provide input into policies, processes and procedures related to clinical equipment networking and medical devices.</li><li>
Serve as a reference source for clinical engineering and clinical staff with regards to appropriate procedures for the integration of clinical equipment to the information system.</li><li>
Evaluate Clinical Engineering departmental logistics, workflow and technical considerations in order to create downtime plans/solutions; and write related procedures for the Clinical Engineering management and associates.</li></ul><div></div><div>
Team Work &amp; Customer Satisfaction (25%)</div><ul><li>
Help to create and foster an environment of innovation; work to identify and remove roadblocks and enables collaboration between clinical engineering and IT services; advocates for the adoption of behaviors and skills related to networking and IT throughout the Clinical Engineering department.</li><li>
Capability to identify, develop and serve all customers and stakeholders to the highest level of satisfaction; ensuring the highest level of customer satisfaction within the scope of responsibilities.</li><li>
Inform management of all situations that are out of the norm or are of an emergent nature or involve a negative impact on patient care.</li><li>
Must be able to communicate verbally and in written form, presenting a professional image at all times.</li><li>
Work with the team to continuously drive improvements in operational delivery and/or technical skills.</li><li>
Conduct departmental rounds to promote communications with customers.</li><li>
Maintain a clean and safe work place.</li><li>
Provide technical assistance to Clinical Engineering associates as necessary.</li><li>
Provide coordinated technical training and mentoring to Clinical Engineering associates as needed.</li><li>
Provide mentoring and precepting of Clinical Engineering Technicians.</li><li>
Brief department management on statuses and risks, including taking the role of champion for medical device integration projects at Client sites.</li><li>
Clearly communicate best practices, roadblocks, timelines and/or risks to management.</li></ul><ul><li>
All other duties as assigned.</li></ul><div></div><div>
Skills and Experience</div><ul><li>
2+ years of prior experience in the support and service of medical equipment and systems is required</li><li>
Formal clinical equipment make/model specific manufacturer and/or aftermarket training required</li><li>
Expertise with computer operating systems is required</li><li>
Working knowledge of HL7, DICOM, TCP/IP and other communications protocols and standards is required</li><li>
Understanding of computer and network security highly desired</li><li>
Experience and/or training in project management strongly preferred</li><li>
Must be knowledgeable of medical device technology.</li><li>
Knowledgeable of the operation of and have experience in the maintenance and repair of a wide variety of medical equipment and systems.</li><li>
Strong working knowledge of electronics, anatomy, physiology, medical terminology, regulatory guidelines, and biomedical principles.</li><li>
Knowledge of HIPAA and security industry standards; acting as department resource for ePHI and HIPAA queries</li><li>
Knowledge of and capability to understand the clinical application of medical technologies is required.</li><li>
Knowledgeable of the various networking technologies employed in healthcare.</li><li>
Knowledgeable of the communications protocols used in the healthcare.</li><li>
Advanced analysis of test data and interpretation of schematic diagrams is frequently required.</li><li>
Proficient in the use of Microsoft Office applications required; including Excel, Word, PowerPoint, Visio, Project and Outlook</li></ul><div><br>
Education and Qualifications</div><ul><li>
Must possess a two-year Associates Degree or be a graduate of military BMET training, or has attended and graduated from formal training in an equivalent technical program</li><li>
An additional associates or bachelor&rsquo;s degree in Information Systems is highly desired</li><li>
Networking, Security, SysAdmin or other relevant certifications strongly preferred</li></ul><div>
At TRIMEDX, we are committed to cultivating a workplace culture where every associate feels valued, supported, and empowered to thrive. This culture reflects our belief that our people are our foundation, their well-being is essential, and shared success is built through meaningful work, recognition, and opportunities for growth.</div><div></div><div><i>
We embrace people&rsquo;s differences which include age, race, color, ethnicity, gender, gender identity, sexual orientation, national origin, education, genetics, veteran status, disability, religion, beliefs, opinions and life experiences.</i></div><div></div><div>
Visit our <div>website</div> to view our Workplace Culture Commitment , along with our social channels to see what our team is up to: <div>Facebook</div>, <div>LinkedIn</div>, <div>Twitter</div>.</div><div></div><div><br>
TRIMEDX is an Equal Opportunity Employer. Drug-Free Workplace.</div><div><i>
Because we are committed to providing a safe and productive work environment, TRIMEDX is a drug-free workplace. Accordingly, Associates are prohibited from engaging in the unlawful manufacture, sale, distribution, dispensation, possession, or use of any controlled substance or marijuana, or otherwise being under the influence thereof, on all TRIMEDX and Customer property or during working/on-call hours.</i></div></div>

CE Cyber Field Specialist

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