clinical research supervisor

Children's Hospital Colorado

<div><h2 class="jobSectionHeader"><b>Job Overview</b></h2>
<div>
<div><div><div><p><b>SUMMARY</b></p><p>
The Supervisor Clinical Research is responsible for managing day-to-day operations of assigned clinical research programs and/or studies conducted by Principal Investigators (PIs) at the University of Colorado Anschutz Medical Campus. Achieves research program and/or study objectives while ensuring team effectiveness, including but not limited to, with definition of best practices and developing subject recruitment strategies, identifying enrollment barriers and implementing appropriate interventions.</p><p></p><p><b><br>
SHIFT</b></p><p>
CCHRI department - supporting the Multidisciplinary 3.0 team</p><p>
Monday - Friday</p><p>
8:00 a.m. - 4:30 p.m.</p><p>
Hybrid eligible</p><p></p><p><b><br>
ESSENTIAL FUNCTIONS</b></p><p><i>
An employee in this position may be called upon to do any or all of the following essential functions. These examples do not include all of the functions which the employee may be expected to perform.</i></p><br>
<p></p><ul><li>
Develops work plans used to achieve research program and/or study goals and performance metrics. Provides oversight and reporting on team finances.</li><li>
Evaluates team performance and assists with the definition and maintenance internal processes. Fulfills customer service standards and participates in the resolution of operational and customer service escalations. Serves as a champion of enterprise-wide culture, influencing culture change to support divisional objectives.</li><li>
Assists with the facilitation of communications to the organization on research related projects and topics. Maintains effective working relationships with peers, stakeholders and leadership across the organization.</li><li>
Assigns and reviews work, provides work instruction to on-the-job or formal training, and develops a minimum of seven (7) team members. Evaluates performance of team members, providing continuous feedback. Manages discipline and performance issues. Hires and terminates team members. Identifies resource needs and develops recommendations for meeting such needs.</li><li>
Contributes to and/or manages resource allocation, budgets and financial performance for assigned programs and/or studies.</li><li>
Oversees the collection, compilation, documentation, review and quality assurance of clinical research data. Serves as a subject matter expert to internal and external stakeholders regarding protocol requirements, problem-solving programs, processes and best practices.</li><li>
Plans and manages research-related activities and ensures work is performed according to research protocol as defined per contract, sponsor, organizational standards, and/or Institutional Review Board (IRB) guidelines.</li><li>
Accountable for the development, implementation, maintenance and adherence of program- and/or study-specific strategies, policies, procedures and best practices. Monitors overall compliance with all applicable regulatory bodies.</li><li>
Contributes to the development, maintenance and delivery of technical orientation and ongoing training. Accountable for ensuring credentialing requirements of team members are met and maintained.</li></ul><p></p><p><b><br>
MINIMUM QUALIFICATIONS</b></p><p><b>
Education:</b><b> </b>Bachelor&rsquo;s degree in a related field is required.</p><p><b>
Experience:</b><b> </b>Minimum of four (4) years of clinical research related experience is required.</p><p><b>
Equivalency:</b><b> </b>Minimum of seven (7) years of clinical research related experience may be considered in lieu of minimum education and experience requirements.</p><p><b>
Certification(s):</b></p><p><b>
Licensure(s):</b> None</p><p><b><br>
Salary Information</b><br>
Pay is dependent on applicant's relevant experience.<br>
<br>
Annual Salary Range (Based on 40 hours worked per week): $84,558.69 to $126,838.03<br>
<br>
<b>Benefits Information</b><br>
Here, you matter. As a Children&rsquo;s Hospital Colorado team member, you will receive a competitive pay and benefits package designed to take care of your needs that includes base pay, incentives, paid time off, medical/dental/vision insurance, company provided life and disability insurance, paid parental leave, 403b employer match (retirement savings), a robust wellness program, and access to professional development tools, including an education benefit to help you advance your career.</p><p>
As part of our Total Rewards package, Children's Colorado offers an annual employee bonus program that rewards eligible team members based on organizational performance. If organizational goals are met for the year, the bonus is paid out the following April.</p><p>
Children&rsquo;s Colorado delivers annual base pay increases to eligible team members based on their performance over the previous year.<br>
<br>
<b>EEO Statement</b><br>
It is our intention that all qualified applicants be given equal opportunity and that selection decisions be based on job-related factors. We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, or any other status protected by law or regulation. Be aware that none of the questions are intended to imply illegal preferences or discrimination based on non-job-related information. The position is expected to stay open until the posted close date. Please submit your application as soon as possible as the posting is subject to close at any time once a sufficient pool of qualified applicants is obtained.<br>
<br>
Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of attendance at or graduation from an educational institution. You will not be penalized for redacting or removing this information.</p></div></div></div></div></div>

Clinical Research Supervisor

University of California - San Francisco

<p></p><div><div><div><div>Under the supervision of the Clinical Research Manager, Clinical Research Coordinators (CRC) support the clinical trial management of investigator-sponsored, pharmaceutical-sponsored, and/or other types of consortium trials programs as assigned/needed. Responsibilities include communicating with the Clinical Trial manager to ensure aspects of study initiation of protocols are developed after regulatory and budgetary approval, and report study progress to the appropriate PI. The CRC will support 2-3 active studies and 1-2 follow-up studies, depending on the complexity of the patients and procedures. Independently, the CRC maintains protocol files, data collection and subject source records, develops project management documents and electronic data forms for each assigned study. The CRC supports the investigator in research study project management to assure compliance with the Code of Federal Regulations and the ICH Guidance on Good Clinical (Research) Practice as well as UCSF Institutional policies and IRB protocols. The CRC also supports the research team with additional duties as assigned (e.g., obtaining archived biospecimens or data for ongoing studies).
<br>
<br>
The Clinical Research Coordinator will perform independently or with general direction at the fully operational journey level of the series to execute, manage, and coordinate research protocols, as directed by the Clinical Research Supervisor and/or Principal Investigator (PI); may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies.<br>
<br>
The duties may include, but will not be limited to supporting the management and coordinating the tasks of single or multiple clinical research studies, depending on their size and complexity; act as intermediary between services and departments while overseeing data and specimen management; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; coordinate staff work schedules, assist with training of Assistant CRCs, and assist Clinical Research Supervisor and/or PI with oversight of other research staff; manage Investigator&rsquo;s protocols in the Committee on Human Research online system, as well as renewals and modifications of protocol applications and the implementation of new studies; participate in the review and writing of protocols to ensure institutional review board approval within University compliance; help assure compliance with all relevant regulatory agencies; oversee study data integrity; implement and maintain periodic quality control procedures; interface with departments to obtain UCSF approval prior to study initiation; maintain all regulatory documents; report study progress to investigators; participate in any internal and external audits or reviews of study protocols; and perform other duties as assigned.<br>
<br>
The Department of Urology in the School of Medicine educates medical students, residents, and clinical and postdoctoral fellows in urology; conducts basic science, clinical, and epidemiological research, including clinical trials; and provides professional patient care services. The Department conducts its teaching, research, and patient care activities at five major sites: the Parnassus campus, Mission Bay, San Francisco General Hospital (SFGH), the San Francisco Veterans Administration Medical Center (SFVAMC), and the UCSF Benioff Children&rsquo;s Hospital Oakland.<br>
<br>
<b>Note</b>: The work schedule will be Wednesday (8 hours); remote Tuesday 8hrs via zoom Bayne TH clinic, remaining days, 8 hours a week but can be remote with occasional in-person as needed.<p><br>
The final salary and offer components are subject to additional approvals based on UC policy.</p><p>
Your placement within the salary range is dependent on a number of factors including your work experience and internal equity within this position classification at UCSF. For positions that are represented by a labor union, placement within the salary range will be guided by the rules in the collective bargaining agreement.</p><p>
The salary range for this position is $34.32 - $55.19 (Hourly Rate).</p><p>
To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html</p></div>
</div><div><p><b>Department Description</b></p>
<div>The Department of Urology in the School of Medicine (SOM) educates medical students, residents, and clinical and postdoctoral fellows in urology; conducts basic science, clinical, and epidemiological research, including clinical trials; and provides professional patient care services. The Department conducts its teaching, research, and patient care activities at five major sites: the Parnassus campus, Mission Bay, Zuckerberg San Francisco General (ZSFG), the San Francisco Veterans Administration Medical Center (SFVAMC), and the UCSF Benioff Children&rsquo;s Hospital Oakland.</div>
</div><div><p><b>Required Qualifications</b></p>
<div><ul><li>HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.</li><li>
Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions; and the ability to multi-task in a fast-paced environment while working with a diverse subject population.</li><li>
Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines.</li><li>
Possess strong skills for multitasking, meeting competing deadlines, prioritizing and supporting PIs for multiple departments.
</li><li>Outstanding communication skills</li><li>
Ability to learn new tasks quickly and apply good judgement in unexpected situation</li></ul></div>
</div><div><p><b>Preferred Qualifications</b></p>
<div><ul><li>Fluency in the usage of Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols through this system.</li><li>
Knowledge/experience with research regulatory process</li><li>
Knowledge/experience with in RedCAP database, Oncore</li><li>
Knowledge/experience in submitting protocol to Institutional Review Board (IRB or CHR)</li><li>
Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation.</li><li>
Experience with EPIC medical record system or other electronic medical records.</li><li>
Previous UC experience</li><li>
4yrs college graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.</li><li>
Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.); knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, database building/analysis, and data management within some of the following: Access, Stata, SASS/ SPSS, and Teleform programming platforms.</li><li>
Experience applying the following regulations and guidelines:<ul><li>
Good Clinical Practice Guidelines</li><li>
Health Information and Accountability Act (HIPAA)</li><li>
The Protection of Human Research Subjects</li><li>
CHR regulations for recruitment and consent of research subjects</li><li>
Effective Cash Handling Procedures</li><li>
Environmental Health and Safety Training</li><li>
Fire Safety Training</li></ul></li></ul></div>
</div><div><p><b>About UCSF</b></p>
<div>The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences. We bring together the world&rsquo;s leading experts in nearly every area of health. We are home to five Nobel laureates who have advanced the understanding of cancer, neurodegenerative diseases, aging and stem cells.</div>
</div><div><p><b>Pride Values</b></p>
<div>UCSF is a diverse community made of people with many skills and talents. We seek candidates whose work experience or community service has prepared them to contribute to our commitment to professionalism, respect, integrity, diversity and excellence &ndash; also known as our PRIDE values.
<br>
<br>
In addition to our PRIDE values, UCSF is committed to equity &ndash; both in how we deliver care as well as our workforce. We are committed to building a broadly diverse community, nurturing a culture that is welcoming and supportive, and engaging diverse ideas for the provision of culturally competent education, discovery, and patient care. Additional information about UCSF is available at diversity.ucsf.edu
<br>
<br>
Join us to find a rewarding career contributing to improving healthcare worldwide.</div>
</div><div><p><b>Equal Employment Opportunity</b></p>
<div>The University of California is 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, age, protected veteran status, or other protected status under state or federal law.</div>
</div><div><p><b>Organization</b></p>
<div>Campus</div>
</div><div><p><b>Job Code and Payroll Title</b></p>
<div>009335 CLIN RSCH CRD
</div></div><div><p><b>Job Category</b></p>
<div>Research and Scientific</div>
</div><div><p><b>Bargaining Unit</b></p>
<div>University Professional Technical Employees &ndash; Research Support Professionals Unit (UPTE-RX)
</div></div><div><p><b>Employee Class</b></p>
<div>Career</div>
</div><div><p><b>Percentage</b></p>
<div>60%</div>
</div><div><p><b>Location</b></p>
<div>Oakland, CA, San Francisco, CA</div>
</div><div><p><b>Campus</b></p>
<div>Benioff Children's Hospital, Mission Bay (SF), Parnassus Heights (SF)</div>
</div><div><p><b>Work Style</b></p>
<div>Fully On-Site</div>
</div><div><p><b>Shift</b></p>
<div>Days</div>
</div><div><p><b>Shift Length</b></p>
<div>6 Hours
</div></div><div><p><b>Additional Shift Details</b></p>
<div>Monday - Friday</div></div></div></div><div></div>

Part-Time Clinical Research Coordinator

University of California, San Francisco

<div>
 Urology
 <br/>
 <br/>
 Full Time
 <br/>
 <br/>
 88471BR
 <br/>
 <br/>
 <strong>
  Job Summary
  <br/>
  <br/>
 </strong>
 Under the supervision of the Clinical Research Manager, Clinical Research Coordinators (CRC) support the clinical trial management of investigator-sponsored, pharmaceutical-sponsored, and/or other types of consortium trials programs as assigned/needed. Responsibilities include communicating with the Clinical Trial manager to ensure aspects of study initiation of protocols are developed after regulatory and budgetary approval, and report study progress to the appropriate PI. The CRC will support 2-3 active studies and 1-2 follow-up studies, depending on the complexity of the patients and procedures. Independently, the CRC maintains protocol files, data collection and subject source records, develops project management documents and electronic data forms for each assigned study. The CRC supports the investigator in research study project management to assure compliance with the Code of Federal Regulations and the ICH Guidance on Good Clinical (Research) Practice as well as UCSF Institutional policies and IRB protocols. The CRC also supports the research team with additional duties as assigned (e.g., obtaining archived biospecimens or data for ongoing studies).
 <br/>
 <br/>
 The Clinical Research Coordinator will perform independently or with general direction at the fully operational journey level of the series to execute, manage, and coordinate research protocols, as directed by the Clinical Research Supervisor and/or Principal Investigator (PI); may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies.
 <br/>
 <br/>
 The duties may include, but will not be limited to supporting the management and coordinating the tasks of single or multiple clinical research studies, depending on their size and complexity; act as intermediary between services and departments while overseeing data and specimen management; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; coordinate staff work schedules, assist with training of Assistant CRCs, and assist Clinical Research Supervisor and/or PI with oversight of other research staff; manage Investigator&rsquo;s protocols in the Committee on Human Research online system, as well as renewals and modifications of protocol applications and the implementation of new studies; participate in the review and writing of protocols to ensure institutional review board approval within University compliance; help assure compliance with all relevant regulatory agencies; oversee study data integrity; implement and maintain periodic quality control procedures; interface with departments to obtain UCSF approval prior to study initiation; maintain all regulatory documents; report study progress to investigators; participate in any internal and external audits or reviews of study protocols; and perform other duties as assigned.
 <br/>
 <br/>
 The Department of Urology in the School of Medicine educates medical students, residents, and clinical and postdoctoral fellows in urology; conducts basic science, clinical, and epidemiological research, including clinical trials; and provides professional patient care services. The Department conducts its teaching, research, and patient care activities at five major sites: the Parnassus campus, Mission Bay, San Francisco General Hospital (SFGH), the San Francisco Veterans Administration Medical Center (SFVAMC), and the UCSF Benioff Children&rsquo;s Hospital Oakland.
 <br/>
 <br/>
 <strong>
  Note
 </strong>
 : The work schedule will be Wednesday (8 hours); remote Tuesday 8hrs via zoom Bayne TH clinic, remaining days, 8 hours a week but can be remote with occasional in-person as needed.
 <br/>
 <br/>
 The final salary and offer components are subject to additional approvals based on UC policy.
 <br/>
 <br/>
 Your placement within the salary range is dependent on a number of factors including your work experience and internal equity within this position classification at UCSF. For positions that are represented by a labor union, placement within the salary range will be guided by the rules in the collective bargaining agreement.
 <br/>
 <br/>
 The salary range for this position is $34.32 - $55.19 (Hourly Rate).
 <br/>
 <br/>
 To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html
 <br/>
 <br/>
 <strong>
  Department Description
  <br/>
  <br/>
 </strong>
 The Department of Urology in the School of Medicine (SOM) educates medical students, residents, and clinical and postdoctoral fellows in urology; conducts basic science, clinical, and epidemiological research, including clinical trials; and provides professional patient care services. The Department conducts its teaching, research, and patient care activities at five major sites: the Parnassus campus, Mission Bay, Zuckerberg San Francisco General (ZSFG), the San Francisco Veterans Administration Medical Center (SFVAMC), and the UCSF Benioff Children&rsquo;s Hospital Oakland.
 <br/>
 <br/>
 <strong>
  Required Qualifications
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
  </li>
  <li>
   Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions; and the ability to multi-task in a fast-paced environment while working with a diverse subject population.
  </li>
  <li>
   Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines.
  </li>
  <li>
   Possess strong skills for multitasking, meeting competing deadlines, prioritizing and supporting PIs for multiple departments.
  </li>
  <li>
   Outstanding communication skills
  </li>
  <li>
   Ability to learn new tasks quickly and apply good judgement in unexpected situation
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Preferred Qualifications
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Fluency in the usage of Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols through this system.
  </li>
  <li>
   Knowledge/experience with research regulatory process
  </li>
  <li>
   Knowledge/experience with in RedCAP database, Oncore
  </li>
  <li>
   Knowledge/experience in submitting protocol to Institutional Review Board (IRB or CHR)
  </li>
  <li>
   Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation.
  </li>
  <li>
   Experience with EPIC medical record system or other electronic medical records.
  </li>
  <li>
   Previous UC experience
  </li>
  <li>
   4yrs college graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
  </li>
  <li>
   Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.); knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, database building/analysis, and data management within some of the following: Access, Stata, SASS/ SPSS, and Teleform programming platforms.
  </li>
  <li>
   Experience applying the following regulations and guidelines:
  </li>
  <ul>
   <li>
    Good Clinical Practice Guidelines
   </li>
   <li>
    Health Information and Accountability Act (HIPAA)
   </li>
   <li>
    The Protection of Human Research Subjects
   </li>
   <li>
    CHR regulations for recruitment and consent of research subjects
   </li>
   <li>
    Effective Cash Handling Procedures
   </li>
   <li>
    Environmental Health and Safety Training
   </li>
   <li>
    Fire Safety Training
    <br/>
   </li>
  </ul>
 </ul>
 <strong>
  About UCSF
  <br/>
  <br/>
 </strong>
 The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences. We bring together the world&rsquo;s leading experts in nearly every area of health. We are home to five Nobel laureates who have advanced the understanding of cancer, neurodegenerative diseases, aging and stem cells.
 <br/>
 <br/>
 <strong>
  Pride Values
  <br/>
  <br/>
 </strong>
 UCSF is a diverse community made of people with many skills and talents. We seek candidates whose work experience or community service has prepared them to contribute to our commitment to professionalism, respect, integrity, diversity and excellence &ndash; also known as our PRIDE values.
 <br/>
 <br/>
 In addition to our PRIDE values, UCSF is committed to equity &ndash; both in how we deliver care as well as our workforce. We are committed to building a broadly diverse community, nurturing a culture that is welcoming and supportive, and engaging diverse ideas for the provision of culturally competent education, discovery, and patient care. Additional information about UCSF is available at diversity.ucsf.edu
 <br/>
 <br/>
 Join us to find a rewarding career contributing to improving healthcare worldwide.
 <br/>
 <br/>
 <strong>
  Equal Employment Opportunity
  <br/>
  <br/>
 </strong>
 The University of California is 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, age, protected veteran status, or other protected status under state or federal law.
 <br/>
 <br/>
 <strong>
  Organization
  <br/>
  <br/>
 </strong>
 Campus
 <br/>
 <br/>
 <strong>
  Job Code and Payroll Title
  <br/>
  <br/>
 </strong>
 009335 CLIN RSCH CRD
 <br/>
 <br/>
 <strong>
  Job Category
  <br/>
  <br/>
 </strong>
 Research and Scientific
 <br/>
 <br/>
 <strong>
  Bargaining Unit
  <br/>
  <br/>
 </strong>
 University Professional Technical Employees &ndash; Research Support Professionals Unit (UPTE-RX)
 <br/>
 <br/>
 <strong>
  Employee Class
  <br/>
  <br/>
 </strong>
 Career
 <br/>
 <br/>
 <strong>
  Percentage
  <br/>
  <br/>
 </strong>
 60%
 <br/>
 <br/>
 <strong>
  Location
  <br/>
  <br/>
 </strong>
 Oakland, CA, San Francisco, CA
 <br/>
 <br/>
 <strong>
  Campus
  <br/>
  <br/>
 </strong>
 Benioff Children's Hospital, Mission Bay (SF), Parnassus Heights (SF)
 <br/>
 <br/>
 <strong>
  Work Style
  <br/>
  <br/>
 </strong>
 Fully On-Site
 <br/>
 <br/>
 <strong>
  Shift
  <br/>
  <br/>
 </strong>
 Days
 <br/>
 <br/>
 <strong>
  Shift Length
  <br/>
  <br/>
 </strong>
 6 Hours
 <br/>
 <br/>
 <strong>
  Additional Shift Details
  <br/>
  <br/>
 </strong>
 Monday - Friday
</div>


Solace Clinical Research

<p><b>Job Summary</b><br/>We are seeking a dynamic and highly organized Clinical Research Site Manager to lead and oversee the daily operations of our clinical trial site. In this pivotal role, you will coordinate all aspects of clinical trials, ensuring compliance with regulatory standards, maintaining high-quality documentation, and fostering a patient-centered environment. Your leadership will drive the successful execution of research studies, facilitate effective communication among team members, and uphold the integrity of data collection and management. This position offers an exciting opportunity to contribute to groundbreaking medical research while supporting the advancement of healthcare solutions.</p><p><b>Responsibilities</b></p><ul><li>Supervise and coordinate the activities of clinical research staff, including nurses, coordinators, and laboratory personnel, ensuring seamless trial operations</li><li>Manage patient recruitment, screening, enrollment, and ongoing monitoring to ensure adherence to study protocols and regulatory requirements</li><li>Oversee data collection processes, review source documents for accuracy, and ensure proper documentation in accordance with ICH GCP standards and FDA regulations</li><li>Maintain compliance with HIPAA regulations and ensure confidentiality of patient information throughout all trial activities</li><li>Review clinical documentation such as case report forms (CRFs), laboratory results, vital signs, and adverse event reports for completeness and accuracy</li><li>Monitor clinical laboratory procedures including blood sampling, phlebotomy, and specimen handling to ensure quality standards are met</li><li>Utilize electronic medical record (EMR) systems and statistical software for data management, analysis, and reporting purposes</li><li>Ensure adherence to CDISC standards for data formatting and reporting in clinical trials</li><li>Conduct regular site audits to verify compliance with protocol requirements and regulatory guidelines</li><li>Facilitate training sessions on Good Clinical Practice (GCP), FDA regulations, and study-specific procedures for staff members</li></ul><p><b>Qualifications</b></p><ul><li>Proven supervising experience in a clinical research environment or healthcare setting</li><li>Strong knowledge of clinical trials management, including patient monitoring and data collection techniques</li><li>Familiarity with medical terminology, clinical laboratory procedures, and blood sampling techniques</li><li>Experience with EMR systems, statistical software, and data management tools used in clinical research</li><li>In-depth understanding of FDA regulations, ICH GCP guidelines, HIPAA compliance, and CDISC standards</li><li>Certification in Good Clinical Practice (GCP) from a recognized issuer for CA or equivalent is required; additional certifications such as an ICH GCP certificate are preferred</li><li>Background in nursing or clinical laboratory work is advantageous</li><li>Excellent analysis skills with attention to detail for reviewing documentation and ensuring protocol adherence</li><li>Ability to lead teams effectively while maintaining a positive work environment</li></ul><p>Join us in advancing innovative healthcare solutions by managing impactful clinical research studies. Your expertise will help shape the future of medicine while supporting a collaborative team dedicated to excellence in clinical development.</p><p>Pay: $20.00 - $38.00 per hour</p><p>Benefits:</p><ul><li>401(k)</li><li>Health insurance</li><li>Paid time off</li></ul><p>Work Location: In person</p>

Clinical Research Site Manager

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: $100,000-$110,000</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>
The candidate will be an integral member of the senior leadership team within the Clinical Protocol &amp; Data Management (CPDM) Office of the Herbert Irving Comprehensive Cancer Center (HICCC). Responsibilities include but are not limited to: coordinating the data management activities of the CPDM, while providing supervision and delegation of work assignments and evaluation of the CPDM Clinical Research Coordinators (CRCs) and Data Coordinators(DCs); creating and promoting professional development opportunities (both internally and externally) for staff; implementing processes and that improve, streamline, and stimulate the work environment; continually assessing trial complexity/workload and resource allocation to ensure patient safety and clinical research excellence; ensuring and promoting positive relationships and outcomes with private industry and other external agencies.</p>
<p>
The Clinical Research Manager reports directly to the Assistant Director, Clinical Research Operations.</p>
<p>
Subject to business needs, we may support flexible and hybrid work arrangements. Options will be discussed during the interview process.</p>
<p></p>
<p>Responsibilities</p>
<p><b>
STAFFING</b></p>
<ul>
<li>Posts/justifies new and replacement positions, screens applicants</li>
<li>On-boards and trains staff (protocol, university, departmental training)</li>
<li>Liaises with the HICCC HR representative for scheduling medical surveillance, JCAHO, and other HR-related functions</li>
<li>Makes appropriate salary recommendations for new and existing staff based on prior experience and conducts annual staff performance reviews (including establishing and continually monitoring FY goals)</li>
</ul>
<p><b>SUPERVISION</b></p>
<ul>
<li>Monitors, directs, and supervises staff in a manner that facilitates efficient level of operations</li>
<li>Determines CRC and DC workloads and protocol assignments</li>
<li>Assures the subject data collected by the CRCs is organized and submitted in a timely manner</li>
<li>Develops quality control mechanisms to ensure accurate data reporting</li>
<li>Assists with CRF development, accuracy, and implementation for investigator initiated trials</li>
<li>Ensures CRC&rsquo;s are adequately prepared for and successfully manage all monitoring and/or auditing visits
</li>
</ul><p><b>PROTOCOL/DISEASE BASE TEAM MANAGEMENT</b></p>
<ul>
<li>Provides protocol management and research expertise by participating in discussions at disease team and collaborative research meetings, ensuring operational feasibility, compliance, and strategic alignment with CPDM and Cancer Center goals.</li>
<li>Leads ongoing assessment of trials within the portfolio to evaluate feasiblity, accrual trends, and resource utilization. Implements priority scoring and portfolio review processes to ensure staffing and support are aligned with institutional priorities and study performance.</li>
Organizes and coordinates project activities, collaborating with multidisciplinary teams - including investigators, research nurses, coordinators and regulatory staff <li>- to ensure timely completion of study start-up, activation, and conduct.</li>
<li>Represents the department at conferences and meetings, maintaining effective communication channels between clinical, research, and administrative stakeholders to promote consistent study management, issue resolution, and operational best practices.</li>
</ul>
<p><b>FINANCE MANAGEMENT</b></p>
<ul>
<li>Prepares and reviews study budgets for submission, negotiation, and ongoing financial monitoring to ensure accuracy, compliance, and alignment with departmental standards.</li>
<li>Monitors, reports, and interprets variances to approved budgets. Collaborates with the Assistant Director to develop and execute action plans that address financial gaps and optimize resource utilization. Uses forecasting tools to project financial outcomes and proactively identify risks and opportunities.</li>
<li>Implements strategies to support financial stability and operatinal efficiency across assigned studies and departmental functions. Ensures financial practices align with institutional priorities, long-term sustainability goals, and portfolio management objectives.</li>
</ul>
<p><b>DEPARTMENT INITIATIVES</b></p>
<ul>
<li>Assist the CPDM Leadership Team in developing, implementing, and executing departmental Standard Operating Procedures (SOPs).</li>
<li>Develop standardized forms, study tools, and promote cross-coverage with CPDM Leadership to ensure coverage, provide appropiate staff updates, in-services, trainings, etc.</li>
</ul>
<p><b>OTHER</b></p>
<ul>
<li>Performs other related duties as assigned.</li>
</ul>
<p></p><p>Minimum Qualifications</p>
<ul>
<li>Bachelor&rsquo;s Degree or equivalent in education, training and experience, plus 4 years of related experience.</li>
</ul>
<p></p><p>Preferred Qualifications</p>
<ul>
<li>Certification as a Clinical Research Professional through a national accrediting body such as ACRP and/or SoCRA.</li>
</ul>
<p></p><p>Other Requirements</p>
<ul>
<li>Minimum one year of supervisory experience.</li>
<li>Experience in clinical research setting necessary, including a thorough understanding of ICH-GCP and CFR guidelines.</li>
<li>Excellent interpersonal and organizational skills.</li>
<li>Computer skills, proficiency with MS Office products (Word, Excel, PowerPoint).</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>

Clinical Research Manager

University Of Cincinnati

<p></p><div><p><b>Current UC employees must apply internally via </b><b><i>SuccessFactors</i></b></p><div></div><p><b><br>
Next Lives at the University of Cincinnati</b></p><p></p><div><br>
Founded in 1819, the University of Cincinnati ranks among the nation&rsquo;s best urban public research universities. Home to more than 53,600 students, 12,000 faculty and staff, and over 360,000 living alumni, UC, a Carnegie 1 institution, combines research prowess with a physical setting The New York Times has called &ldquo;the most ambitious campus design program in the country.&quot; UC's momentum has never been stronger as the anchor of the Cincinnati Innovation District, the oldest cooperative education (co-op) program in the country with students earning $94 million annually through paid experiences, an academic health system, and as a member of the Big 12 Conference. The university contributes $10.6 billion in economic impact to the city and $22.7 billion to the state of Ohio. At UC, next is all of us. Learn more at uc.edu.</div><div></div><div><br>
UC is a mission-driven organization where we are committed to student success and positively transforming the community through scholarship and service. We thrive on innovation, making an impact, and fostering an environment where staff and faculty are key contributors to UC&rsquo;s success.</div><div></div><div><br>
</div><div><div><div><h2 class="jobSectionHeader"><b>Job Overview</b></h2></div><div><p>
As one of the oldest medical schools in the country, the University of Cincinnati College of Medicine (COM) has a reputation for training best-in-class health care professionals and developing cutting-edge procedures and research that improves the health and clinical care of patients. In partnership with the UC Health academic healthcare system and Cincinnati Children&rsquo;s Hospital Medical Center, the College of Medicine&rsquo;s doctors and faculty are transforming the world of medicine every day. The Department of Internal Medicine is a top-tier department with world-renowned faculty and staff. With world-class research, teaching and medical practice opportunities, why not choose the University of Cincinnati College of Medicine?</p><p></p><p><br>
The University of Cincinnati College of Medicine, Department of Internal Medicine, Division of Rheumatology, Allergy, and Immunology is seeking a Clinical Research Manager to participate, plan, and evaluate multiple, complex and/or multi-faceted research programs for one or more designated departments, programs, or central units. Duties can span a broad range of activities or be primarily focused within one or more areas of the clinical research spectrum.</p></div></div><p></p><div><div><h2 class="jobSectionHeader"><b><br>
Essential Functions</b></h2></div><div><ul><li>
Oversee the implementation of clinical research studies, including adherence to SOPs, Good Clinical Practice, and FDA regulations as applicable. Work on contracts. Assist leadership in developing strategic planning goals and initiatives for clinical research. Contribute to protocol design and logistics. Work with study sponsors, IRB, and other regulatory offices as needed.</li><li>
Interact on a daily basis with the director, research staff, and principal investigator to ensure all protocol requirements are met.</li><li>
Liaise and work efficiently in collaboration with the director and with other departments at the university to ensure adequate financial accounting regarding clinical research projects, including budget development and reconciliation.</li><li>
Provide daily management/supervision to the clinical research staff to promote maximum enrollment, safe participation and exemplary conduct, and generation of accurate and complete data of the clinical research activities.</li><li>
Serve as an informational and referral resource for the research community.</li><li>
Continually evaluate research processes for compliance and efficiency within the department and the university and contribute ideas for improvement.</li><li>
Mitigate risk through working with physicians/faculty, divisions, legal and/or other departments. Work with necessary parties to identify compliance, legal, IP and business/financial risk.</li><li>
May serve as Principal Investigator on select research projects.</li><li>
May provide direct and/or indirect supervision to exempt and non-exempt staff (i.e., hiring/firing, performance evaluations, disciplinary action, approve time off, etc.).</li><li>
Perform related duties based on departmental need. This job description can be changed at any time.</li></ul></div></div><p></p><div><div><h2 class="jobSectionHeader"><b><br>
Required Education</b></h2></div><div><ul><li>
Bachelor&rsquo;s Degree</li><li>
Nine (9) years of relevant work experience and/or other specialized training can be used in lieu of education requirement.</li></ul></div></div><p></p><div><div><h2 class="jobSectionHeader"><b><br>
Required Experience</b></h2></div><div><p>
Five (5) years related experience.</p></div></div><div><div><h2 class="jobSectionHeader"><b>
Additional Qualifications Considered</b></h2></div><div><ul><li>
Experience in an academic or clinical setting in the area of clinical specialization.</li><li>
SoCRA or ACRP certification.</li></ul></div></div><p></p><div><div><h2 class="jobSectionHeader"><b><br>
Physical Requirements/Work Environment</b></h2></div><ul><li>
Sitting - Continuously</li></ul></div></div><p></p><p><b><br>
Compensation and Benefits</b></p><p></p><p><br>
UC offers an exceptional benefits package designed to support your well-being, financial security, and work-life balance. (UC Benefits) Eligibility may vary by position and FTE status. Highlights include:</p><p></p><p><br>
Salary/Hourly Pay Rate Information:</p><p></p><p><b><br>
Comprehensive Tuition Remission</b></p><p>
UC provides tuition remission for you and your eligible dependents, covering tuition costs for nearly all undergraduate and graduate programs offered by the university.</p><p></p><p><b><br>
Robust Retirement Plans</b></p><p>
As a UC employee, you won&rsquo;t contribute to Social Security (except Medicare). Instead, you&rsquo;ll choose between state pension plans (OPERS, STRS) or an Alternative Retirement Plan (ARP), with UC contributing 14&ndash;18% of your salary based on position.</p><p></p><p><b><br>
Real Work-Life Balance</b></p><p>
UC prioritizes work-life balance with a generous time-off policy, including:</p><p>
Vacation and sick time</p><p>
11 paid holidays and additional end-of-year paid time off (Winter Season Days)</p><p>
6 weeks of paid parental leave for new parents</p><p></p><p><b><br>
Additional Benefits Include:</b></p><ul><li>
Competitive salary based on experience</li><li>
Comprehensive health coverage (medical, dental, vision, prescription)</li><li>
Flexible spending accounts &amp; wellness programs</li><li>
Professional development &amp; mentorship opportunities</li></ul><p></p><p><br>
To learn more about why UC is a great place to work, please visit our Careers Page.</p><p></p><p><br>
UC is an E-Verify employer. If hired into this position, you will be required to provide satisfactory proof of employment eligibility by providing acceptable, original forms of identification for employment verification via the Federal I-9 employment verification process. Click here for a list of acceptable documents.</p><p><br>
</p><p><b>Important</b>: To apply you must create a profile and submit a complete job application through the UC applicant portal. We are unable to consider &ldquo;easy apply&rdquo; applications submitted via other websites. For questions about the UC recruiting process or to request accommodations with the application, please contact UC HR at jobs@uc.edu.</p><p></p><p><b><br>
Equal Opportunity Employer. Building a workplace where all qualified applicants will receive consideration for employment, including Individuals with Disabilities and Protected Veterans.</b></p><p></p><p><br>
REQ: 101960</p></div>

Clinical Research Manager, Division of Rheumatology, Allergy, and Immunology

INSIGHT

<div></div><div><div><b>Job Title:</b> Clinical Research Coordinator III &ndash; Team Lead<br>
<b>Department:</b> Clinical Research Operations<br>
<b>Location:</b> On-site (Insight Hospital &amp; Medical Center Chicago)<br>
<b>Schedule:</b> Full-time, Monday through Friday (8AM-5PM) &ndash;additional flexibility required to meet job requirements</div>
<div><b>Reports To:</b> Director of Clinical Trials</div>
<p></p><div><b>Position Summary</b></div>
<div>The Clinical Research Coordinator III &ndash; Team Lead is a senior-level hybrid role responsible for leading the coordination of complex clinical trials while supervising and mentoring the on-site research team. This position functions as a &ldquo;player/coach,&rdquo; combining direct study coordination with oversight of Clinical Research Coordinators and Clinical Research Assistants. The CRC III &ndash; Team Lead ensures operational excellence, regulatory compliance, and a culture of accountability and continuous improvement.</div>
<div>This role also collaborates closely with the Patient Recruitment department to support enrollment success through candidate prescreening, outreach, and community engagement. In addition, the CRC III &ndash; Team Lead supports regulatory and quality functions directly with the team and in collaboration with centralized regulatory and quality resources.</div>
<p></p><div><b>Core Competencies</b></div>
<ul><li>Advanced knowledge of clinical trial operations, GCP, FDA regulations, and IRB processes</li>
<li>Strong leadership and coaching skills with a collaborative, solutions-oriented mindset</li>
<li>Excellent communication and interpersonal abilities across diverse stakeholders</li>
<li>High attention to detail, time management, and multitasking capabilities</li>
<li>Commitment to quality, compliance, and participant safety</li></ul><br>
<div></div><div><b>Key Responsibilities</b></div>
<div>Study Leadership and Coordination</div>
<ul><li>Serve as lead coordinator on high-priority or complex trials, managing all phases from startup to closeout</li>
<li>Provide backup coverage and operational support for other coordinators during absences or escalations</li>
<li>Ensure protocol adherence, timely data entry, and accurate documentation across assigned studies</li>
</ul><div><b>Team Supervision and Mentorship</b></div>
<ul><li>Supervise and mentor Clinical Research Coordinators I and II and Clinical Research Assistants</li>
<li>Lead onboarding, training, and ongoing development for study staff</li>
<li>Conduct regular team huddles, protocol reviews, and best practice sessions</li>
</ul><div><b>Regulatory and Quality Support</b></div>
<ul><li>Support regulatory and quality functions directly with the team and in collaboration with centralized regulatory and quality resources</li>
<li>Ensure accurate completion, review, and submission of IRB documents, amendments, and safety reports</li>
<li>Maintain essential regulatory files and sponsor communications</li>
<li>Participate in internal audits, monitoring visits, and CAPA implementation</li>
</ul><div><b>Patient Recruitment and Engagement</b></div>
<ul><li>Partner with the Patient Recruitment department to develop and execute enrollment strategies</li>
<li>Conduct candidate prescreening and outreach activities to support recruitment goals</li>
<li>Participate in community engagement efforts to raise awareness and build trust with potential participants</li>
</ul><div><b>Operational Collaboration</b></div>
<ul><li>Serve as liaison between the research team, investigators, sponsors, and institutional departments</li>
<li>Assist in resource planning, visit scheduling, and workload balancing</li>
<li>Contribute to SOP development, workflow optimization, and quality improvement initiatives</li>
</ul>
<p></p><div><b>Qualifications and Requirements</b></div>
<ul><li>Education: Bachelor&rsquo;s degree in life sciences, nursing, or a related field</li>
<li>preferred</li>
<li>Experience: Minimum 4 to 6 years of clinical research coordination experience, including leadership or mentorship responsibilities</li>
<li>Certification: Clinical research certification (e.g., ACRP, SOCRA) preferred</li>
<li>Technical Skills: Proficiency in CTMS, E-Source, E-Reg, EDC platforms, and regulatory systems; strong computer literacy (Microsoft Office Suite, electronic communication tools)</li>
<li>Knowledge Base: Advanced understanding of clinical trial operations, GCP, FDA regulations, and IRB processes</li>
<li>Communication: Excellent written and verbal communication skills; ability to interact effectively with investigators, sponsors, staff, and participants</li>
<li>Leadership: Demonstrated ability to supervise, mentor, and develop staff while fostering accountability and collaboration</li>
<li>Organizational Skills: High attention to detail, time management, and multitasking capabilities; ability to prioritize competing demands</li>
<li>Flexibility: Willingness to adjust schedule to accommodate study visits, meetings, and events that may occur earlier, later, or on weekends</li>
<li>Travel: Ability to travel to training meetings, conferences, satellite sites and other Insight Health System locations as required</li>
<li>Professional Standards: Commitment to quality, compliance, participant safety, and continuous improvement</li></ul></div>

Clinical Research Coordinator III - Team Lead

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Clinical Research Coordinator III - Team Lead