clinical trials coordinator

Columbia University

<div><ul><li>Job Type: Officer of Administration</li>
<li>Bargaining Unit:</li>
<li>Regular/Temporary: Regular</li>
<li>End Date if Temporary:</li>
<li>Hours Per Week: 35</li>
<li>Standard Work Schedule:</li>
<li>Building:</li>
<li>Salary Range: $70,000 - $80,000</li>
</ul><div><i>The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.</i></div><br>
<div></div>
<p></p>
<p>Position Summary</p>
<p>
Reporting directly to the Associate Director of Regulatory Science (the &quot;Associate Director&quot;) of the Clinical Trials Office (the &quot;CTO&quot;) of Columbia University's Vagelos College of Physicians &amp; Surgeons (&quot;P&amp;S&quot;) at Columbia University Irving Medical Center (&quot;CUIMC&quot;), the Regulatory Science Specialist assists the Associate Director in overseeing the CTO's regulatory compliance and providing assistance to the research community in the development and conduct of clinical trials.</p>
<p>
The CTO, which is operated jointly with the New York-Presbyterian Hospital (&quot;NYPH&quot;) assists investigators and academic/research staff in developing clinical trials at CUIMC and provides administrative resources and infrastructure to build and sustain clinical trials research.</p>
<p></p>
<p>Responsibilities</p>
<p>
The Regulatory Science Specialist is responsible for the following:</p>
<ul>
<li>Collaborates with the Associate Director, the Executive Director of the CTO (the &quot;Director&quot;), the Medical Director of the CTO, CUIMC faculty and administration and NYPH administration in meeting the institutional needs regarding clinical trial compliance, quality assurance, training and process-improvement goals.</li>
<li>Assists the Associate Director in developing and implementing policies and procedures designed to assure that clinical trials are carried out in compliance with applicable federal and state regulations, including those promulgated in the U.S. Food and Drug Administration, the U.S. Department of Health and Human Services, the Centers for Medicare and Medicaid Services and the rules of the Joint Commission.</li>
<li>Assists the Medical Director and Associate Director of Regulatory Science in implementing the IND/IDE Assistance Program, which provides regulatory guidance in connection with investigator initiated clinical trials.</li>
<li>Assists in the implementation of a training program for research personnel, including research newsletters, workshops, and didactic training sessions upon request.</li>
<li>Provides guidance regarding regulatory and institutional requirements to investigators and research personnel</li>
<li>Provides assistance and support in creating and maintaining www.ClinicalTrials.gov records in compliance with applicable regulations and policies.</li>
<li>Participates in the Clinical Trials Monitoring Assistance Program (CTMAP) that includes oversight and monitoring of investigator/coordinator compliance with standard operating procedures as they pertain to the conduct of FDA regulated clinical trials.</li>
<li>Collaborates with the CTSA and the HRPO/IRB in developing programs such as programs to increase patient recruitment and to address regulatory and compliance needs.</li>
<li>Provides support of RecruitMe Platform for the CUIMC research community including:</li>
<li>Coordinating with investigators and research teams in RecruitMe entry.</li>
<li>Developing training and process improvement projects, and other project management duties with RecruitMe.</li>
<li>Collaborating with the Director and Associate Director to implement objectives and workflow strategies for content maintenance on RecruitMe and other CTO websites.</li>
<li>Fulfilling reporting requirements for management, including metrics from Google Analytics data.</li>
<li>Monitoring external communications for social media websites.</li>
<li>Liaising with RecruitMe contacts, information technology (&quot;IT&quot;) groups, CTSA leadership, outside vendors and/or internal partners in research for needs related to RecruitMe and other CTO websites.</li>
Represents the Manager and Director in his/her absence and all other duties as assigned.<br>
<li>
</li>
</ul><p></p><p>Minimum Qualifications</p>
<ul>
<li>Bachelor's degree</li>
<li>At least 4 years of experience in conducting clinical research</li>
</ul>
<p></p><p>Preferred Qualifications</p>
<ul>
<li>In depth knowledge of federal, state and local laws and regulations and industry requirements and practices regarding the proper conduct of clinical trials:</li>
<li>Particular knowledge and experience in FDA matters, including regulations relating to INDs and IDEs</li>
<li>Expert working knowledge in GCP, patient safety standards and IRB regulations pertinent to clinical research</li>
<li>Demonstrable ability to collaborate with partners in research, investigators and coordinators</li>
<li>Excellent verbal and written communication skills</li>
<li>Excellent interpersonal and presentation skills</li>
<li>Strong computer skills required, including proficiency with content management systems, social media websites, Microsoft Office</li>
Ability to manage/handle multiple tasks, teams, and teamwork simultaneously.<br>
<li>
</li>
</ul><p></p><p>Equal Opportunity Employer / Disability / Veteran</p>
<p>
Columbia University is committed to the hiring of qualified local residents.</p></div>

Regulatory Science Specialist

Endeavor Health

<div><div>Hourly Pay Range:</div>
$24.86 - $37.29 - The hourly pay rate offered is determined by a candidate's expertise and years of experience, among other factors.<div></div><div>
Position Highlights:</div><div><ul><li><div>
Position: Research Coordinator- Anesthesia</div></li><li><div>
Location: Evanston, IL</div></li><li><div>
Full Time/Part Time: Full Time</div></li><li><div>
Hours: Monday-Friday, 8:00am &ndash; 4:30pm</div></li><li><div>
Required Travel: Travel required among Endeavor</div></li></ul><div></div><div>
What you will do:</div><ul><li><div>
Work with the Director of Pain Medicine, Vice Chair of Research and Chair of Anesthesia to develop a sustainable research infrastructure and personnel team.</div></li><li><div>
Aid in IRB protocol development, submissions, inclusive of HIT review requests.</div></li><li><div>
Recruit and consent patients from a variety of Endeavor sites.</div></li><li><div>
Maintain organized and detailed study records.</div></li><li><div>
Aid in recruiting other personnel that are required to build a sustainable program</div></li><li><div>
Perform data entry, quality control, and cleaning tasks in order to prepare data for statistical analyses</div></li><li><div>
Regulatory work for clinical trial startup and closeout</div></li><li><div>
Serve as connection to CRAs and PI</div></li><li><div>
Train other team members</div></li><li><div>
Develop into a clinical trials subject matter expert</div></li><li><div>
Analyze and summarize data and present it in a variety of ways including power point presentations</div></li><li><div>
Perform scientific literature searches as required</div></li><li><div>
Participate in abstract, poster and manuscript preparation</div></li></ul><div><br>
What you will need:<br>
Education: Masters-level coursework in a health service related field (eg, public health), or Bachelor-level coursework with 3-5 years of working experience in a related field<br>
Certification: SOCRA or ACRP preferred, but not required.<br>
Experience:</div><ul><li><div>
Experience leading projects and teams</div></li><li><div>
Previous clinical or health services research experience (preferred)</div></li><li><div>
 A commitment to producing high-quality work</div></li><li><div>
Basic understanding of the research process</div></li><li><div>
Strong communication, interpersonal and organizational skills</div></li><li><div>
Ability to work both independently and in teams</div></li><li><div>
Ability and willingness to learn new techniques to deploy on current and future studies</div></li><li><div>
Unique or Preferred Skills: Clinical Trials experience (preferred), experience in perioperative and pain management clinical research suggested.</div></li></ul><div></div><div>
Benefits:</div><ul><li><div>
Career Pathways to Promote Professional Growth and Development</div></li><li><div>
Various Medical, Dental, Pet and Vision options</div></li><li><div>
Tuition Reimbursement</div></li><li><div>
 Free Parking</div></li><li><div>
Wellness Program Savings Plan</div></li><li><div>
Health Savings Account Options</div></li><li><div>
Retirement Options with Company Match</div></li><li><div>
Paid Time Off and Holiday Pay</div></li><li><div>
Community Involvement Opportunities</div></li><li><div>
Visa Sponsorship Available (Nursing and Lab roles)</div></li></ul><div></div><div>
Endeavor Health is a fully integrated healthcare delivery system committed to providing access to quality, vibrant, community-connected care, serving an area of more than 4.2 million residents across six northeast Illinois counties. Our more than 25,000 team members and more than 6,000 physicians aim to deliver transformative patient experiences and expert care close to home across more than 300 ambulatory locations and eight acute care hospitals &ndash; Edward (Naperville), Elmhurst, Evanston, Glenbrook (Glenview), Highland Park, Northwest Community (Arlington Heights) Skokie and Swedish (Chicago) &ndash; all recognized as Magnet hospitals for nursing excellence. For more information, visit www.endeavorhealth.org.</div><div></div><div>
When you work for Endeavor Health, you will be part of an organization that encourages its employees to achieve career goals and maximize their professional potential.</div><div></div><div>
Please explore our website (www.endeavorhealth.org) to better understand how Endeavor Health delivers on its mission to &ldquo;help everyone in our communities be their best&rdquo;.</div><div></div><div>
Endeavor Health is committed to working with and providing reasonable accommodation to individuals with disabilities. Please refer to the main career page for more information.</div><div></div><div>
Diversity, equity and inclusion is at the core of who we are; being there for our patients and each other with compassion, respect and empathy. We believe that our strength resides in our differences and in connecting our best to provide community-connected healthcare for all.</div><div></div><div>
EOE: Race/Color/Sex/Sexual Orientation/ Gender Identity/Religion/National Origin/Disability/Vets, VEVRRA Federal Contractor.</div></div></div>

Research Coordinator- Anesthesia

Orlando Health

<div>Position Summary:
<div><i>
Orlando Health is a 3,200-bed system that includes 15 wholly-owned hospitals and emergency departments; rehabilitation services, cancer institutes, heart institutes, imaging and laboratory services, wound care centers, physician offices for adults and pediatrics, skilled nursing facilities, an in-patient behavioral health facility, home healthcare services in partnership with LHC Group, and urgent care centers in partnership with CareSpot Urgent Care. Nearly 4,200 physicians, representing more than 80 medical specialties and subspecialties have privileges across the Orlando Health system, which employs nearly 22,000 team members. Areas of clinical excellence are orthopedics, heart and vascular, cancer care, neurosciences, surgery, pediatric specialties, neonatology, women&rsquo;s health and trauma</i></div><div></div><div><b><br>
Successful candidates joining our TEAM will be eligible for:</b></div><ul><li>
Outstanding Benefits with a 403(B) match for full and part-time employees.</li><li>
Retirement Savings plan.</li><li>
Paid Time Off plan.</li><li>
Education Assistance programs; Tuition reimbursement, Student Loan repayment program, and Preferred Education Program.</li><li>
Maternity leave; 4 weeks yearly.</li><li>
Among many other benefit programs. Benefits do kick in from day one!</li></ul><div></div><div><b><br>
Position Summary</b>
<br>
Participate in the development, coordination and implementation of research and administrative strategies essential to the management of clinical trials research.</div><div></div><ul><li><br>
Phlebotomy experience a plus</li></ul><div></div><div><b><br>
Seeking individual with a high attention to detail, quick learner, and able to work in a fast-paced environment. Individual must be comfortable working with patient&rsquo;s and in an operating room setting</b>.</div><div></div><div><b><br>
Essential Functions</b>
 <br>
Participate in the coordination of multi-site or large-scale clinical trials research studies conducted by a supervising principal
<br>
investigator(s) in support of activities that meet objectives of assigned research protocol(s).
 <br>
Assesses patients for protocol eligibility and communicates findings to investigator/physician.
 <br>
Coordinates the implementation of protocol procedures.
 <br>
Operates specialized equipment as needed in assigned area, if applicable.
 <br>
Assesses and monitors patient responses and adverse reactions; reports same to accountable sources.
 <br>
Provides appropriate patient and family education.
 <br>
Completes a variety of reports, documents, and correspondence for regulatory agencies, participating clinical trial sites and
<br>
for internal purposes.
 <br>
Collaborates with physicians and other healthcare staff to ensure adherence to FDA and protocol guidelines; identify
<br>
potential problems and/or inconsistencies and take action as appropriate.
 <br>
Assist in the preparation and submission of amendments to clinical trials protocols to the IRB.
 <br>
Provides educational in-services as needed.
 <br>
Promotes interdepartmental cooperation and coordination for each protocol.
 <br>
Maintains reasonably regular, punctual attendance consistent with Orlando Health policies, the ADA, FMLA and other
<br>
federal, state, and local standards.
 <br>
Maintains compliance with all Orlando Health policies and procedures.
<br>
Other Related Functions
 <br>
Assists in the development of treatment orders for active studies, to be reviewed by the treating physician.
 <br>
Assists the research team in preparing for site audits.
 <br>
Attends appropriate departmental and/or corporate meetings
 <br>
Attends study group and investigator meetings as required.
 <br>
Demonstrates ability in using computer software specific to department.
 <br>
Support the team of data managers by answering complex questions and entering information into the EDC if necessary.</div><div><b><br>
Education/Training</b>
<br>
Must meet one of the following:
 <br>
Bachelor&rsquo;s degree in health-related field (i.e., Healthcare Administrative, Nursing, Respiratory Therapy, Health &amp; Wellness
<br>
or Health Information Management); or
 <br>
Associate degree in related field (i.e., Healthcare Administration, Nursing, Respiratory Therapy, Health &amp; Wellness or Health
<br>
Information Management) and one (1) year of clinical research or healthcare experience (in addition to the requirements
<br>
listed in the Experience section); or
 <br>
Graduate of an accredited allied health program and one (1) year of clinical research or healthcare experience (in addition
<br>
to the requirements listed in the Experience section).
 <br>
If no degree, experience may be substituted at a two for one ratio and a minimum of one-year clinical research experience
<br>
required.</div><div></div><div><b><br>
Licensure/Certification</b>
 <br>
All RNs and other Clinical Research Coordinators involved in direct patient care may be required to be licensed by the
<br>
medical director.
 <br>
BLS/Healthcare Provider certification required.</div><div><b><br>
Experience</b>
 <br>
One (1) year of healthcare experience required</div></div><div></div>

Clinical Research Coordinator I - Orlando Health - Corporate - Full Time

The IMA Group

<div><div><h2 class="jobSectionHeader"><b>Clinical Research Coordinator &ndash; Austin, TX</b></h2><div>
(<b>Clinical Research - Research Coordinator - Research Assistant - Clinical Research Associate</b>)</div><div>
</div><div>
Join <b>IMA Clinical Research</b> as a <b>Clinical Research Coordinator</b> and help drive innovative <b>clinical research</b> studies that improve patient outcomes. This role is ideal for candidates experienced in <b>Research</b>, <b>Research Coordination</b>, <b>Clinical Research Associate</b> work, or <b>Research Assistant</b> responsibilities.</div><h3 class="jobSectionHeader"><b>
What You&rsquo;ll Do</b></h3></div><ul><li>
Support and coordinate clinical research trials from start to finish</li><li>
Guide patients through study visits and research procedures</li><li>
Work closely with investigators, sponsors, labs, and monitors</li><li>
Complete blood draws and clinical tasks</li><li>
Maintain accurate research documentation (ALCOA)</li></ul><div><h3 class="jobSectionHeader"><b>
What We&rsquo;re Looking For</b></h3></div><ul><li>
At least 2 years of <b>clinical research</b> experience (required)</li><li>
Phlebotomy experience (required)</li><li>
Bachelor&rsquo;s degree; Master&rsquo;s or CCRC a plus</li><li>
Strong organization skills and ability to manage multiple research studies</li></ul><div><h3 class="jobSectionHeader"><b>
What We Offer</b></h3></div><ul><li>
Fast-paced clinical research environment</li><li>
No on-call work</li><li>
Tuition support &amp; student loan assistance</li><li>
Medical, dental, vision, 401(k) match, PTO, holidays</li></ul><div><div>
</div><div>
Join our growing <b>Clinical Research</b> team and build your career as a <b>Clinical Research Coordinator</b>, <b>Research Coordinator</b>, <b>Clinical Research Associate</b>, or <b>Research Assistant</b>.</div></div><div>
</div><div></div><div><b><i>The IMA Group is an Affirmative Action/Equal Opportunity Employer</i></b>
</div><div></div><div>Our Government Services Division supports local, state, and federal agencies and delivers professional and objective medical and psychological examinations as well as ancillary services. Our Payer Services Division meets the evaluation and screening needs of Carriers, TPAs, Public Entities and Employers and includes behavioral health and physical medicine specialty services, working with a wide range of organizations within the workers' compensation, disability, liability, and auto markets. Our Clinical Research Division performs all types of Phase II-IV clinical trials in multiple therapeutic areas through a flexible nationwide network of site locations and virtual capabilities.
</div><div></div><div>#LI-EG1 #LI-ONSITE</div></div>

Clinical Research Coordinator - Growing Clinical Research Team - Austin, TX

City of Hope

<div><div><div><div><div><div><div><div><div><b>Clinical Study Coordinator - Clinical Research (On-Site-Duarte,CA)</b></div><div>
Join the transformative team at City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. City of Hope&rsquo;s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix. Our dedicated and compassionate employees are driven by a common mission: To deliver the cures of tomorrow to the people who need them today.</div><div>
Duarte Medical Center seeks a full-time, on-site Clinical Study Coordinator to support oncology clinical trials. Under the supervision of the Director, Clinical Research, this patient-facing role involves coordinating First in Human to Phase III and Investigator-Initiated Trials. Responsibilities include patient recruitment, informed consent, trial coordination, data management, and regulatory compliance. The position requires in-depth knowledge of clinical trial regulations, strong organizational skills, and the ability to collaborate with investigators and clinical staff in a fast-paced environment.</div><div><b>
As a successful candidate, you will:</b></div><ul><li>
Understand and apply federal regulations (FDA, OHRP, GCP/ICH, HIPAA) and institutional policies.</li><li>
Follow and execute clinical trial protocols and procedures.</li><li>
Coordinate participant recruitment, informed consent, and care.</li><li>
Communicate with participants, investigators, and sponsors to ensure clear understanding and compliance.</li><li>
Monitor and document participant eligibility, safety, and protocol adherence, and report adverse events promptly.</li><li>
Pursue continuous education and training opportunities, staying updated with the latest clinical research information, and maintain necessary certifications and licensure.</li></ul></div></div></div></div></div></div></div><div></div><div><div><div><b>
Your qualifications should include:</b></div><ul><li>
Bachelor&rsquo;s degree in Science, Health or related field from an accredited university; 3 additional years of experience plus the minimum experience requirement may substitute for minimum education.</li><li>
Minimum of 2 years research or relevant clinical experience</li><li>
ACRP or SOCRA certification within 1 year of employment</li><li>
International Air Transport Association (IATA) within 1 month of employment</li><li>
Good Clinical Practice (GCP) within 1 month of employment</li><li>
Human Subjects Protection (HSP) within 1 month of employment</li><li>
Basic Life Support (BLS) within 1 month of employment</li></ul><div><b>
City of Hope is an equal opportunity employer. To learn more about our commitment to diversity, equity, and inclusion, please </b><b>click here</b><b>.</b></div><div><b>
To learn more about our Comprehensive Benefits, please </b><b>CLICK HERE</b><b>.</b></div></div></div></div>

Clinical Study Coordinator

Sarasota Memorial Health Care System

<div>
 <strong>
  Job Description
  <br/>
  <br/>
 </strong>
 <strong>
  Department
  <br/>
  <br/>
 </strong>
 Research Institute
 <br/>
 <br/>
 <strong>
  Job Summary
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   This position is fully on-site, no option for remote*
   <br/>
   <br/>
  </li>
 </ul>
 Responsible for the coordination and conduct of clinical trials, under the direction of the Principal Investigator and the Manager/Director, in accordance with the standards of good clinical practice and FDA regulations.
 <br/>
 <br/>
 This position at our state of the art instutute is perfect for a well rounded clinical individual.
 <br/>
 <br/>
 <strong>
  Required Qualifications
  <br/>
  <br/>
 </strong>
 Require graduate of an accredited school of nursing or a diploma program. For new hires after 2012, Bachelor of Science Degree in nursing (BSN) is required within specified timeframe as outlined in the New Hire BSN Agreement policy (126.045).
 <br/>
 <br/>
 <ul>
  <li>
   Require certification as a Clinical Research Coordinator within one (1) year of eligibility.
  </li>
  <li>
   Require appropriate training in Human Subject Protection and Safe Shipping/Handling of Bio-Hazardous Specimens (must be completed within thirty (30) days of hire.
  </li>
  <li>
   Require a valid driver's license and the ability to drive to off-site locations.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Preferred Qualifications
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Prefer knowledge of commonly used computer applications.
  </li>
  <li>
   Prefer experience in a clinical research and/or a medical/surgical or critical care setting.
  </li>
  <li>
   Prefer ability to initiate work without supervision.
  </li>
  <li>
   Prefer demonstrated proficiency in interpersonal skills with staff, subjects, families, physicians, and sponsor/auditors of clinical trials.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Required License And Certs
  <br/>
  <br/>
 </strong>
 BLS: Basic Life Support/CPR
 <br/>
 <br/>
 FL RN: FL Registered Nurse License
 <br/>
 <br/>
 <strong>
  Employment Screening Requirements
  <br/>
  <br/>
 </strong>
 As part of Sarasota Memorial Health Care System&rsquo;s commitment to keeping people safe, all individuals providing care to vulnerable populations are required to undergo background screening through The Florida Care Provider Background Screening Clearinghouse. https://info.flclearinghouse.com/
</div>


Clinical Research Nurse (*on site position - no remote)*

MaineHealth

<div><p><b>Description</b><br>
</p><p><br>
Management/Leadership<br>
Req #: 59494</p><p></p><p><br>
Summary:</p><p>
This position is for someone interested in joining a hands-on team at the MaineHealth Institute for Research. This Research Nurse Coordinator Supervisor will work at the direction of the Manager, Clinical Trials Office, playing a key role in the delivery of our Oncology therapeutic clinical trials mission to provide the highest quality research conduct and the best experience possible to our research participants. This role will serve as an educational resource to nurses conducting clinical research studies, supervising staff, overseeing training and ongoing operational support of Oncology Research Nurse Coordinators.</p><p>
A hybrid work schedule from our Scarborough, Maine location is available for this position. A resume or CV AND Cover Letter are required to be considered for this position.</p><p>
Learn more about the MaineHealth Institute for Research in this short video!</p><p></p><p>
Required Minimum Knowledge, Skills, and Abilities (KSAs)</p><p></p><ul><li><b>
Education: </b>See &quot;License/Certifications&quot;</li><li><b>
License/Certifications: </b>Current license to practice as a Registered Nurse in the State of Maine. Current Clinical Research Coordinator Certification (ACRP or SOCRA) required.</li><li><b>
Experience: </b>5+ years of research experience is required. MH research experience is preferred. Thorough knowledge of theory, practice, principles, processes and issues of nursing usually acquired through 2-3 years of clinical experience.</li><li><b>
Additional Skills/Requirements Required: </b>Demonstrated ability to serve in a role as a leader or a mentor. Ability to manage complex projects through all phases of development, implementation, and follow-up.</li><li><b>
Additional Skills/Requirements Preferred: </b>N/A</li></ul><br>
<p></p><br>
<br>
Additional Information<br>
<br>
With a career at any of the MaineHealth locations across Maine and New Hampshire, you&rsquo;ll be working with health care professionals that truly value the people around them &ndash; both within the walls of the organization and the communities that surround it.<br>
<br>
We offer benefits that support an individual's needs for today and flexibility to plan for tomorrow &ndash; programs such as paid parental leave, a flexible work policy, student loan assistance, training and education, along with well-being resources for you and your family.<br>
<br>
MaineHealth remains focused on investing in our care team and developing an inclusive environment where you can thrive and feel supported to realize your full potential. If you&rsquo;re looking to build a career in a place where people help one another deliver best-in-class care, apply today.<p></p><p><br>
If you have questions about this role, please contact lauren.robare@mainehealth.org</p></div>

Supervisor - Research Nurse Coordinator/RN - MaineHealth Institute for Research

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