regional clinical research associate

Arizona Arthritis and Rheumatology

<div>Description:
<p>
Arizona Arthritis &amp; Rheumatology Associates, P.C. is the largest private Rheumatology practice in the United States. The practice has over 60 providers, 15 sites and over 350 employees providing assessment and treatments for our rheumatology patients. Our providers work together to keep patients healthy, and are recognized for excellence in medicine and for being pioneers in new treatments, ably supported by our Research department.</p><p>
We are an equal employment opportunity employer and will consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or disability.</p><p>
Our vision is to provide the best Rheumatology care, anywhere and, to balance sustainable operation with the highest possible level of patient care.</p><p>
We are a seeking an ambitious, friendly, positive, and compassionate Clinical Research Coordinator to join our team.</p><p>
The Regional Research Manager reports to the Director of Clinical Research and is responsible for the clinical research staff &amp; daily operations at each assigned medical clinic (research site).</p><p>
RESPONSIBILITIES</p><ul><li>
Travel daily to research sites to provide support and complete job responsibilities listed below</li><li>
First line manager (direct, supervise, and evaluate) to research coordinators and assistants</li><li>
Conduct training and mentorship of new clinical research staff, ensuring their success</li><li>
Assign tasks and studies to ensure workloads are balanced among recruitment staff</li><li>
Utilize Clinical Trial Management System weekly to ensure productivity goals are met</li><li>
Monitor electronic source data capture system reports to ensure data and query goals are met</li><li>
Meet with employees monthly to review metrics and conduct weekly huddles with the team</li><li>
Perform HR responsibilities including interviews, reviews, reprimands, and terminations</li><li>
Manage operations at the clinical sites and facilitate all medical staff&rsquo;s participation in research</li><li>
Implement Clinical Trial Agreements &amp; Budgets and ensure model fiscal operations</li><li>
Assist with qualifying and onboarding vendors and staff for clinical services as required per study</li><li>
Approve and order supplies and equipment as needed from sponsors and vendors</li><li>
Ensure clinical research staff have the skills and resources necessary for success</li><li>
Ensure clinical sites have the medical equipment and resources necessary for success</li><li>
Ensure clinical sites are engaging in recruitment activities and meeting patient enrollment goals</li><li>
Facilitate operational changes using professional and positive motivation</li><li>
Ensure compliance with research protocols, handbook policies, standard operating procedures, ICH-GCP Standards, FDA regulations, medical laws and implement solutions for compliance</li><li>
Perform quality assurance and complete corrective action and prevention assessment plans</li><li>
Conduct Pre-Study Visits and Site Initiation Visits for new clinical trials</li><li>
Serve as an escalation point all clinical trials and first point of contact for site staff members</li><li>
Provide ongoing support, needs assessment, and issue resolution to clinical sites and staff on an ongoing basis, and escalate to Director of Clinical Research when needed</li><li>
Communicate with physicians, vendors, sponsors and CROs to address and resolve issues</li><li>
Collaborate with fellow Regional Research Managers to ensure a consistent and coordinated department and management style across all sites nationally</li><li>
Meet with administrative staff regularly to ensure all research operations are running smoothly</li><li>
Perform duties for coordinators and managers when there is a lapse in coverage</li><li>
Participate in continuing education to remain a subject matter expert on all research protocols, medical indications, company policies, standard operating procedures, ICH-GCP regulations, FDA 21 CFR, IRB Guidelines, and all applicable local and federal medical laws</li></ul><p>
Learn more about AARA on our website at http://azarthritis.com</p>
Requirements:
<p>
QUALIFICATIONS</p><ul><li>
Bachelor&rsquo;s Degree, or equivalent</li><li>
2 years&rsquo; experience as clinical research coordinator</li><li>
Subject Matter expert in clinical research and relevant clinical indications</li><li>
Understands specific state and federal regulations governing medicine and privacy</li><li>
Possess strong leadership &amp; organizational skills</li><li>
Excellent verbal and written communication skills</li><li>
Willing and able to travel to all regional offices daily</li><li>
Management experience and/or formal training preferred but not required</li><li>
Clinical Research Certification (CRCC/CCRP) preferred but not required</li></ul></div>

Clinical Research Regional Manager

ACL Digital

<div>
 <p>
  <strong>
   Title: Clinical Research Associate
  </strong>
 </p>
 <p>
  <strong>
   Location: Santa Monica, CA
  </strong>
 </p>
 <p>
  <strong>
   Duration: 18 months
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Description:
  </strong>
 </p>
 <p>
  Must meet all requirements for Clinical Research Associate position and have demonstrated proficiency in all relevant areas. With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required. Assures site compliance with the routine protocol and regulatory requirements and quality of data. Assists in the setting and updating of study timelines. Assists in CRO or vendor selection. With guidance from supervisor coordinates CROs or vendors. Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans. Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies. Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams. May participate in abstract presentations, oral presentations and manuscript development. Interfaces with individuals in other functional areas to address routine study issues. May be asked to assist in the training of Clinical Research Associates and Clinical Project Assistants. Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives. Travel is required.
 </p>
 <p>
  Excellent verbal, written, interpersonal and presentation skills are required. Working knowledge and experience with Word, PowerPoint and Excel. Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials. Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures. Ability to develop tools and processes that increase measured efficiencies of the project. Must be able to anticipate obstacles and proactively develop solutions to achieve project goals. Must have a general understanding of functional issues and routine project goals from an organizational perspective.
 </p>
</div>


Clinical Research Associate

Medpace

<div>
 <strong>
  Clinical Research Coordinators wanted at Medpace! Become a CRA and join our growing team!
  <br/>
  <br/>
 </strong>
 This is an exciting opportunity for clinical research professionals with at least one year of Clinical Research Coordinator experience to fill Clinical Research Associate (CRA) openings with Medpace. Through our
 <em>
  PACE&reg;
 </em>
 Training Program, you will receive the training needed to become a fully functional CRA with the opportunity to work home-based. You will also have the opportunity to earn a generous travel bonus in addition to a competitive salary.
 <br/>
 <br/>
 <strong>
  WE OFFER THE FOLLOWING
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Competitive travel bonus;
  </li>
  <li>
   Equity/Stock Option program;
  </li>
  <li>
   Training completion and retention bonus
  </li>
  <li>
   Annual merit increases;
  </li>
  <li>
   401K matching;
  </li>
  <li>
   The opportunity to work from home;
  </li>
  <li>
   Flexible work hours across days within a week;
  </li>
  <li>
   Retain airline reward miles and hotel reward points;
  </li>
  <li>
   Home office furniture allowance, laptop, mobile phone with hotspot for internet access anywhere;
  </li>
  <li>
   In-house travel agents, reimbursement for airline club, and TSA pre-check;
  </li>
  <li>
   Opportunity for leadership positions &ndash; Lead CRA, CRA Manager, Clinical Trial Manager, Training and Development Manager, and many more;
  </li>
  <li>
   CRA training program (PACE&reg;);
  </li>
  <li>
   Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts;
  </li>
  <li>
   In-house administrative support for all levels of CRAs; and
  </li>
  <li>
   Opportunities to work with international team of CRAs.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Responsibilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;
  </li>
  <li>
   Communication with the medical site staff including coordinators, clinical research physicians, and their site staff;
  </li>
  <li>
   Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
  </li>
  <li>
   Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements;
  </li>
  <li>
   On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward;
  </li>
  <li>
   Verification that the investigator is enrolling only eligible subjects;
  </li>
  <li>
   Regulatory document review;
  </li>
  <li>
   Medical device and/or investigational product/drug accountability and inventory;
  </li>
  <li>
   Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
  </li>
  <li>
   Assess the clinical research site&rsquo;s patient recruitment and retention success and offering suggestions for improvement; and
  </li>
  <li>
   Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Qualifications
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Must have a minimum of a Bachelor&rsquo;s degree in a health or science related field;
  </li>
  <li>
   Experience as a Clinical Research Coordinator (minimum 1 year);
  </li>
  <li>
   Ability to travel 60-70% to locations nationwide is required; some visits may be conducted remotely;
  </li>
  <li>
   Must maintain a valid driver&rsquo;s license and the ability to drive to monitoring sites;
  </li>
  <li>
   Proficient knowledge of Microsoft&reg; Office;
  </li>
  <li>
   Strong communication and presentation skills; and
  </li>
  <li>
   Must be detail-oriented and efficient in time management.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Compensation
  <br/>
  <br/>
 </strong>
 A target salary range of $60,000 - $140,000 with potential for bonus and equity awards. Your compensation will be based on your skills and experience. Medpace offers the following benefits for full-time positions: medical, dental, vision, 401(k), vacation policy, sick days, paid holidays, work from home flexibility, short-term disability, long-term disability, health savings and flexible savings accounts, life and AD&amp;D insurance, pet insurance, and reimbursement for travel expenses (including food and gas allowance, rental cars, and hotel accommodations). For more details, please discuss with your recruiter.
 <br/>
 <br/>
 <strong>
  <br/>
  <br/>
 </strong>
 <strong>
  Medpace Overview
  <br/>
  <br/>
 </strong>
 Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
 <br/>
 <br/>
 <strong>
  Why Medpace?
  <br/>
  <br/>
 </strong>
 People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
 <br/>
 <br/>
 The work we&rsquo;ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
 <br/>
 <br/>
 <strong>
  Medpace Perks
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Flexible work environment
  </li>
  <li>
   Competitive PTO packages &ndash; starting at 20+ days
  </li>
  <li>
   Company-sponsored employee appreciation events
  </li>
  <li>
   Employee health and wellness initiatives
  </li>
  <li>
   Competitive compensation and benefits package
  </li>
  <li>
   Structured career paths with opportunities for professional growth
  </li>
  <li>
   Discounts for local businesses
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Awards
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Named a Top Workplace in 2024 by The Cincinnati Enquirer
  </li>
  <li>
   Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
  </li>
  <li>
   Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  What To Expect Next
  <br/>
  <br/>
 </strong>
 A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
 <br/>
 <br/>
</div>


Clinical Research Coordinator to Home-Based CRA (Clinical Research Associate) (LA)

The University of Michigan

<p></p><div><div><div><h2 class="jobSectionHeader"><b>How to Apply</b></h2><p>
A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.</p><h2 class="jobSectionHeader"><b>
Job Summary</b></h2><p>
This position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the CRC-Assistant position on the Michigan Medicine CRC Career Ladder is required.</p><p>
This position will serve as a Clinical Research Coordinator in the Pediatric Hematology/Oncology division, providing administrative study coordination and data entry support to faculty and research teams for the University of Michigan CS Mott Children's Hospital. Our program is renowned for our expertise in cancers like leukemia, lymphoma, and solid tumors including neuroblastoma, sarcoma and brain tumors which affect children, adolescents, and young adults. We are members of national clinical trials organizations like COG, NANT, TACL and PNOC for pediatric and AYA cancer patients. Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society. As a team member, we will invest in your education, training, career development and certification.</p><h2 class="jobSectionHeader"><b>
Mission Statement</b></h2><p>
Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.</p><h2 class="jobSectionHeader"><b>
Why Join Michigan Medicine?</b></h2><p>
Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world's most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.</p><p><b>
What Benefits can you Look Forward to?</b></p><ul><li>
Excellent medical, dental and vision coverage effective on your very first day</li><li>
2:1 Match on retirement savings</li></ul><h2 class="jobSectionHeader"><b>
Responsibilities*</b></h2><p><b>
Characteristic Duties and Responsibilities:</b></p><p><b>
Experience as part of a team with all 8 competency domains is expected:</b></p><ul><li>
Scientific Concepts and Research Design</li><li>
Ethical Participant Safety Considerations</li><li>
Investigational Products Development and Regulation</li><li>
Clinical Study Operations (GCPs)</li><li>
Study and Site Management</li><li>
Data Management and Informatics</li><li>
Leadership and Professionalism</li><li>
Communication and Teamwork</li></ul><ul><li>
Assist study teams with all aspects of clinical trial coordination including identifying potential subjects, screening subjects, consenting (minimal risk) and enrolling subjects, and collecting and managing patient and laboratory data for clinical research subjects</li><li>
Coordinate and facilitate correct timing of study visits and procedures with patients and clinic staff</li><li>
Coordinate the collection and integrity of research specimens (collection, processing, shipping/packing, storing, labeling, tracking, etc)</li><li>
Monitor and report abnormal or unexpected findings</li><li>
Create source documents for accurate tracking, collection, and recording of experimental data</li><li>
Utilize critical thinking skills to recognize and solve patient/participant problems including billing issues</li><li>
Work collaboratively with nurses, research pharmacy, physicians, NPs/PAs, phlebotomists and other clinical, research and administrative staff to correct/prevent protocol errors</li><li>
Expeditiously route AE and SAE information between staff, PI, and oversight agencies as appropriate</li><li>
Possibly attend investigator and scientific meetings</li><li>
Serve as a resource and contact person for active protocols</li><li>
Liaison between clinical team and research team to develop processes, troubleshoot complications and facilitate communication</li><li>
Integrate the workflow of many studies running simultaneously</li><li>
Maintain current PEERRS, or OHRP certification; knowledge and application of the Code of Federal Regulations (CFR), Good Clinical Practice (GCP), and FDA regulations, and maintain knowledge of current ICH and CFR guidelines</li><li>
Assist in the completion of regulatory duties including new study activation and processing of amendments and continuing reviews</li><li>
Assist in the preparation of IRB amendments and scheduled continuing reviews, progress reports, safety reports and adverse event reports</li><li>
In coordination with the CTSU staff, communicate with sponsors concerning progress of clinical research, billing calendar/budget issues, subject related problems, recruitment strategies, and specific policies and procedures</li><li>
Act as liaison between study team and sponsors, IRB, federal, state, and University officials and other regulatory agencies to maintain accurate communication of costs, policy changes, fiscal requirements, and other regulatory issues</li></ul><p><b><br>
Supervision Received:</b></p><p>
This position receives direct supervision and reports directly to a CRC-Lead, CRC-Senior, a unit Administrator, Director, or Faculty Principal Investigator. Functional supervision may be received from the Clinical Research Coordinator Senior in the team.</p><p><b>
Supervision Exercised:</b></p><p>
None.</p><h2 class="jobSectionHeader"><b>
Required Qualifications*</b></h2><ul><li>
Bachelor's Degree or higher preferably in health science or health related field or an equivalent combination of related education and experience.</li><li>
At least two years of experience coordinating Clinical Trials.</li><li>
Excellent interpersonal, oral, and written communication skills with exceptional attention to detail.</li><li>
Excellent computer skills including proficiency in Microsoft software applications.</li><li>
Excellent organizational skills including the ability to multitask and work well under time constraints and deadlines.</li><li>
Willingness to be flexible in a dynamic working environment.</li><li>
Ability to work independently with minimal supervision and with diverse teams of people in a diplomatic, collaborative and effective manner.</li><li>
Good attendance record</li></ul><p><b><br>
Intermediate Level:</b></p><ul><li>
Bachelor's degree in health science or an equivalent combination of related education and experience is necessary.
</li><li>Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent and must be achieved by 01/01/24. After 01/01/24, certification is required within six months of date of hire.</li><li>
Minimum 3 years of directly related experience in clinical research and clinical trials.</li></ul><p><b>
Associate Level:</b></p><ul><li>
Bachelor's degree in health science or an equivalent combination of related education and experience is necessary.
</li><li>Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent and must be achieved by 01/01/24. After 01/01/24, certification is required within six months of date of hire.</li><li>
Minimum 2 years of directly related experience in clinical research and clinical trials.</li></ul><p><b><br>
Technician Level:</b></p><ul><li>
Associate degree or an equivalent combination of related education and experience.</li><li>
Minimum 1 year of directly related experience in clinical research and clinical trials.<br>
<br>
OR<br>
</li><li>
an advanced degree in a health-related areas such as: Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD<br>
<br>
OR<br>
</li><li>
Minimum 3 years of human subject experience (clinical, lab or health regulations) such as related patient care, related community health and wellness, related clinical information, and research</li></ul><h2 class="jobSectionHeader"><b>
Desired Qualifications*</b></h2><ul><li>
6+ years of direct related experience</li><li>
Masters Degree</li><li>
Reasonable understanding of clinical research</li><li>
Understanding of medical terminology related to oncology</li><li>
Some IRB/regulatory experience</li><li>
Previous experience with Epic, MiChart, eResearch, OnCore, RedCap</li><li>
Certification or planned certification through ACRP or SOCRA<br>
</li></ul><h2 class="jobSectionHeader"><b>
Work Schedule</b></h2><p>
The position is full-time. The work schedule will typically be Monday-Friday, 8-hour shifts. However, flexibility on weekends and evenings may be required depending on study needs.</p><h2 class="jobSectionHeader"><b>
Modes of Work</b></h2><p>
Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.</p><h2 class="jobSectionHeader"><b>
Underfill Statement</b></h2><p>
This position may be underfilled at the CRC-Associate or CRC-Technician titles based on selected candidates' qualifications.</p><h2 class="jobSectionHeader"><b>
Background Screening</b></h2><p>
Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.</p><h2 class="jobSectionHeader"><b>
Application Deadline</b></h2><p>
Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.</p><h2 class="jobSectionHeader"><b>
U-M EEO Statement</b></h2><p>
The University of Michigan is an equal employment opportunity employer.</p></div></div></div><p></p>
<br><div><div><h3 class="jobSectionHeader"><b>Job Opening ID</b></h3>
<div><p>275216</p>
</div></div><div><h3 class="jobSectionHeader"><b>Working Title</b></h3>
<div><p>Clinical Research Intermediate/Associate</p>
</div></div><div><h3 class="jobSectionHeader"><b>Job Title</b></h3>
<div><p>Clinical Research Coord Inter</p>
</div></div><div><h3 class="jobSectionHeader"><b>Work Location</b></h3>
<div><p>Ann Arbor Campus</p>
</div></div><p>Ann Arbor, MI</p>
<div><h3 class="jobSectionHeader"><b>Modes of Work</b></h3>
<div><p>Hybrid
</p></div></div><div><h3 class="jobSectionHeader"><b>Full/Part Time</b></h3>
<div><p>Full-Time</p>
</div></div><div><h3 class="jobSectionHeader"><b>Regular/Temporary</b></h3>
<div><p>Regular</p>
</div></div><div><h3 class="jobSectionHeader"><b>FLSA Status</b></h3>
<div><p>Exempt</p>
</div></div><div><h3 class="jobSectionHeader"><b>Organizational Group</b></h3>
<div><p>Medical School</p>
</div></div><div><h3 class="jobSectionHeader"><b>Department</b></h3>
<div><p>MM Pediatrics-Hematology Oncol</p>
</div></div><div><h3 class="jobSectionHeader"><b>Posting Begin/End Date</b></h3>
<div><p>3/19/2026 - 4/20/2026</p>
</div></div><div><h3 class="jobSectionHeader"><b>Career Interest</b></h3>
<div><p>Research</p></div></div></div>

Clinical Research Intermediate/Associate

Align Technology

<div><h3 class="jobSectionHeader"><b>Description</b></h3><div><br>
Job Summary<br>
</div><div>
<br>
The Clinical Research Development Associate should have strong skills with program/project management. The Clinical Research Development Associate will provide full-time program/project management support for Align&rsquo;s Clinical Research Development team.<br>
</div><div>
<br>
Essential Duties and Responsibilities<br>
</div><div>
<br>
<ul><li>Owns the Clinical Studies Network (CSN) system configuration in both testing and production environments</li></ul></div><div><br>
<br>
<ul><li>Develop documentation for Research Awards and Collaborative Research programs</li></ul></div><div><br>
<br>
<ul><li>Resolves internal/external program inquiries in a timely manner to ensure customer satisfaction</li></ul></div><div><br>
<br>
<ul><li>Exercises judgment within defined procedures to onboard program vendors</li></ul></div><div><br>
<br>
<ul><li>Streamlines technical design assessments (TDAs), business user preferences (BUPs), and/or user assessment tests (UATs) for Clinical Affairs and Product Innovation processes</li></ul></div><div><br>
<br>
<ul><li>Apply professional procedures to support Clinical Affairs research activities</li></ul></div><div><br>
<br>
<ul><li>Applies professional internal/external communication</li></ul></div><div><br>
<br>
<ul><li>Builds productive internal/external relationships with cross-functional teams</li></ul></div><div><br>
<br>
<ul><li>Under moderate supervision, support Clinical Research Development and Clinical Affairs projects</li></ul></div><div><br>
<br>
Additional responsibilities<br>
</div><div>
<br>
<ul><li>Manage delivery and shipment of research items to universities, orthodontists, and/or general dentists</li></ul></div><div><br>
<br>
<ul><li>Apply company policies and procedures to resolve a variety of issues</li></ul></div><div><br>
<br>
<ul><li>Support Clinical Research Operations team projects, as assigned</li></ul></div><div><br>
<br>
<ul><li>Support Clinical Data Management team projects, as assigned</li></ul></div><div><br>
<br>
<ul><li>Comply with all safety policies, practices and procedures. Report all unsafe activities to supervisor and/or Human Resources</li></ul></div><div><br>
<br>
<ul><li>Participate in proactive team efforts to achieve departmental and company goals</li></ul></div><div><br>
<br>
<ul><li>Perform other duties, as assigned</li></ul></div><div><br>
<br>
Qualifications<br>
</div><div>
<br>
<ul><li>Project/program management skills/experience</li></ul></div><div><br>
<br>
<ul><li>Strong organizational skills</li></ul></div><div><br>
<br>
<ul><li>Knowledge and experience using Adobe Professional</li></ul></div><div><br>
<br>
<ul><li>Ability to think critically and scientifically</li></ul></div><div><br>
<br>
<ul><li>Competency with data management software, including using word-processing, spreadsheet and database software</li></ul></div><div><br>
<br>
<ul><li>Willingness to be reassigned to different tasks in a fast-paced research environment</li></ul></div><div><br>
<br>
<ul><li>Regard for patient information privacy</li></ul></div><div><br>
<br>
<ul><li>Professionalism in interacting with practitioners and academicians</li></ul></div><div><br>
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<ul><li>Strong oral and written communication skills essential</li></ul></div><div><br>
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<ul><li>Ability to prioritize tasks to meet deadlines</li></ul></div><div><br>
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<ul><li>Strong attention to detail and ability to ask clarifying questions</li></ul></div><div><br>
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<ul><li>Ability to work independently with minimal supervision</li></ul></div><div><br>
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Education<br>
</div><div>
<br>
<ul><li>Associate degree</li></ul></div><div><br>
<br>
<ul><li>2+ years of experience in the medical device industry preferred</li></ul></div><div><br>
<br>
<ul><li>Good Clinical Practice (GCP) certification, preferred</li></ul></div><div><br>
<br>
Work Schedule/Hours<br>
</div><div>
<br>
<ul><li>Regular business hours</li></ul></div><h3 class="jobSectionHeader"><b><br>
.</b></h3><div><br>
.</div><h3 class="jobSectionHeader"><b><br>
About Align Technology</b></h3><div>
<b>Your growth and well-being:</b><br>
<br>
At Align, every smile matters. We&rsquo;re committed to helping you thrive by supporting the health, growth, and well-being of our team members through a variety of tools and programs. While specific offerings may vary by location and role, Align employees can typically expect:</div><ul>
<li>Health and well-being programs to keep you thriving in both body and mind.</li>
<li>Employee-exclusive discounts on Invisalign products.</li>
<li>Learning opportunities through online learning resources and support for your individual development plans.</li>
<li>Inclusive, global workplace that fosters collaboration, recognition and belonging.</li>
</ul><div>Country and/or role specific details will be shared with you by your recruiter during the interview process.</div><div>
<br>
<b>Discover Align:</b><br>
<br>
We are a global community of game-changers and smart team players, united by our belief in the power of a smile. Our dynamic team of exceptional employees is dedicated to transforming the industry and creating extraordinary outcomes every day.<br>
</div><div>Align&rsquo;s core values of agility, customer, and accountability are more than words to work by, they are words we live by. The actions we take every day speak to who we are as a company and our focus on being truly impactful. We celebrate our differences, and the many ways we support one another&mdash; ultimately creating a more inclusive organization and world as we continue transforming smiles and changing lives.<br>
</div><div>We foster a culture where thinking differently and seeking new experiences are not just encouraged but celebrated. With the Align Mindset, we empower each other, ensuring every voice is heard and valued in an inclusive environment that inspires creativity and collaboration.<br>
</div><div>At Align, we believe in the power of a smile, and we know that every smile is as unique as our employees. As we grow, we are committed to building a workforce rich in diverse cultural backgrounds and life experiences, fostering a culture of open-mindedness and compassion. We live our company values by promoting healthy people and healthy communities, all with the intent of changing millions of lives, one unique smile at a time.</div><div>
<br>
As part of our commitment to innovation, Align Technology includes exocad and Cubicure, companies that enhance our offerings and extend our impact to industry transformation.</div><div>
<br>
Eager to learn how we embrace our global differences and nurture employee well-being?
<br>
<b>Explore Align's culture here!</b><br>
</div><div>Want to discover more about <b>exocad</b> and <b>Cubicure</b>? Click on their names for additional information.</div><div><br>
<b>
Applicant Privacy Policy:</b><br>
<br>
Review our <b>Applicant Privacy Policy</b> for additional information.<br>
<br>
<b>Equal Opportunity Statement:</b><br>
<br>
Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire.</div></div>

Clinical Research Development Associate

IQVIA

<div><div><div>Durham, 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>

Alto Neuroscience

<div>
 <strong>
  Primary Role
  <br/>
  <br/>
 </strong>
 The Clinical Research Associate (CRA) is responsible for the oversight of assigned investigative sites in accordance with all applicable protocols, project plans, Sponsor SOPs, GCP guidelines, and regulatory requirements from site initiation through site close out. The CRA assists the Clinical Trial Manager and/or Clinical Project Manager by managing their assigned clinical sites to ensure enrollment, timely review of data, identification of site issues, and prompt resolution of issues. The CRA is the primary liaison between the clinical investigator and the Sponsor to ensure the recruitment, enrollment, and site activities are executed on time, within budget, and with the highest quality data standards.
 <br/>
 <br/>
 <strong>
  What You'll Do
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Perform site management and act as the primary liaison to the investigator and site staff ensuring consistent and effective communication related to enrollment status, issues and other relevant study information
  </li>
  <li>
   Conduct Site Evaluation, Site Initiation, Interim Monitoring, Close-out, and other study-specific visits including the completion of visit reports and follow-up letters after each visit
  </li>
  <li>
   Assist with the preparation of appropriate training materials and provide protocol and study related training including GCP and regulatory requirements to assigned sites
  </li>
  <li>
   Evaluate the quality and integrity of site practices to ensure GCP compliance and escalate any quality issues as appropriate
  </li>
  <li>
   Manage site and study progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
  </li>
  <li>
   Ensure the collection and maintenance of required essential documents and ensure these documents are filed in the Investigator Site File and Trial Master File
  </li>
  <li>
   Train site staff on proper preparation, handling, storage, and return/destruction of investigational product(s) and verify compliance during monitoring visits
  </li>
  <li>
   Develop a patient recruitment plan in conjunction with the site, address challenges and barriers to enrollment, and report the subject recruitment rate to the Clinical Project Manager
  </li>
  <li>
   Verify that written informed consent is obtained before each subject&rsquo;s participation in the trial
  </li>
  <li>
   Verify that source documents, other trial records, and CRFs are accurate, complete, and legible and that CRF entries reflect the source
  </li>
  <li>
   Determine whether all adverse events (AEs) are appropriately reported within the time periods required by GCP, the protocol, the Ethic Committees (IRB/IEC), Sponsor and the applicable regulatory requirement(s) Ensure deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements are documented and communicated appropriately and take appropriate action to prevent recurrence of the detected deviations
  </li>
  <li>
   Assist with the coordination and conduct of investigator and study meetings, including preparation and presentation of information
  </li>
  <li>
   Collaborate with team members in a mutually supportive and cooperative manner, as required to achieve study and project goals
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  LOCATION
  <br/>
  <br/>
 </strong>
 Remote
 <br/>
 <br/>
 <strong>
  Travel Requirements
  <br/>
  <br/>
 </strong>
 60% travel required
 <br/>
 <br/>
 (1-2 days per week)
 <br/>
 <br/>
 <strong>
  SALARY RANGE
  <br/>
  <br/>
 </strong>
 $80-125K Base Salary
 <br/>
 <br/>
 <strong>
  Depending On Qualifications And Experience Level
  <br/>
  <br/>
 </strong>
 <strong>
  QUALIFICATONS
  <br/>
  <br/>
 </strong>
 <strong>
  Required Skills
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Experience monitoring clinical trials with rater-administered measures preferred
  </li>
  <li>
   Certified Clinical Research Associate (CCRA) credentialing is preferred
  </li>
  <li>
   Proactive in identifying areas of improvement to drive efficiency within Clinical Operations
  </li>
  <li>
   Knowledge of the clinical research discipline, GCP, and ICH-E6 is essential
  </li>
  <li>
   Excellent interpersonal skills required
  </li>
  <li>
   Proficiency with systems (CTMS, EDC, eTMF) and MS Office (Word, Excel, Outlook)
  </li>
  <li>
   The CRA must possess the ability to work closely with cross-functional colleagues within a small company, displaying innovative thinking, analytical thinking, a strong sense of responsibility, accountability, and integrity
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Education And Experience
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   BS in scientific discipline or pharmacy, RN, or BSN degree, or equivalent combination of education and experience
  </li>
  <li>
   Minimum 2 years of experience, relevant CRO/biotech/pharmaceutical industry, including on-site or remote monitoring experience
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  WHY ALTO
  <br/>
  <br/>
 </strong>
 At Alto Neuroscience, you will play a pivotal role in advancing precision psychiatry and improving how mental health disorders are treated. Join us in building the next generation of personalized neuroscience-based therapeutics.
 <br/>
 <br/>
 A lto Neuroscience is an equal-opportunity employer that does not discriminate on the basis of sex, age, race, color, religion, marital status, sexual orientation, gender identity, pregnancy, disability, or any other characteristic protected by law. We offer a welcoming and inclusive environment in service to one another, our products, the diverse consumers we represent, and the communities we call home. We do all of this with kindness, empathy and respect for each other. The above is intended to describe the general content of and requirements for the performance of this job. It should not be construed as an exhaustive statement of duties, responsibilities or physical requirements.
 <br/>
 <br/>
 - Remote
</div>


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