administrative assistant

clinical research coordinator i Jobs in Boston

clinical research coordinator i

clinical research coordinator Jobs in Boston

clinical research coordinator

clinical research coordinator ii Jobs in Boston

clinical research coordinator ii

clinic/practice assistant ii Jobs in Boston

clinic/practice assistant ii

clinical trial assistant project manager

The General Hospital Corporation

<div>Site: The General Hospital Corporation<p></p><p><br>
Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.</p><p></p><p><b><br>
Job Summary</b></p>
Expectations for All Employees: Supports the organization&rsquo;s missions, vision and values by exhibiting the following behaviors; excellence and competence, collaboration, innovation, respect, personalization, commitment to our community, and accountability and ownership Position Summary: Assists with coordination of CTNI-managed clinical trials
<br>
<br>
Competencies Required:
<br>
Excellent communication skills
<br>
Sound interpersonal skills and the ability to supervise others
<br>
Ability to work independently and display initiative to introduce innovations to research study
<br>
Ability to prepare/monitor budgets
<br>
Ability to identify problems and develop solutions
<br>
Ability to prioritize tasks and set deadlines
<br>
<br>
Primary Duties as Assistant Project Manager of a Clinical Trial:
<br>
1. Schedule SAFER interviews with sites
<br>
2. Obtain interview results from doctors, track results, and communicate results to sites and sponsors
<br>
3. Manage Rater Training using Excel, MGH LMS and RedCap
<br>
4. Manages creation of study deliverables, including SAFER Implementation Plan, Rater Training Plan, etc.
<br>
5. Organize and attend conference calls and distribute minutes accordingly
<br>
6. Attend Investigator and Sponsor Meetings as necessary
<br>
7. Submit study protocols, protocol amendments, and study staff certifications to the IRB
<br>
8. Coordinate and respond to audits by study sponsors
<br>
<br>
Other Tasks, As Required:
<br>
Verifies accuracy of study forms
<br>
Updates study forms per protocol
<br>
Prepares data for analysis and data entry
<br>
Assists with formal audits of data
<br>
Assists with study regulatory submissions
<br>
Verifies subject inclusion/exclusion criteria
<br>
Maintains research data, patient files, regulatory binders and study databases Performs data analysis and QA/QC data checks
<br>
May develop systems for QA/QC
<br>
Acts as study resource for sites
<br>
Prepares for FDA and IRB annual reviews
<br>
Recommends protocol changes and may assist with writing protocols and manuscripts
<br>
Works with PIto prepare complete study reports
<br>
Responsible for quality control
<br>
Designs research protocols in conjunction with PI
<br>
Assists in the selection of study sites
<br>
Tracks and analyzes trends across studies, study sites, and CTNI clinicians Invoices sponsors and processes payments to vendors
<br>
Orders supplies, handles computer and telephone issues, and communicates with property management
<br>
Participates in regular meetings with operations and clinical teams
<br>
Facilitates any rater communication with study sites as requested Creates/distributes study reminders
<br>
Acts as general resource for study information
<br>
<br>
Work Schedule: Monday through Friday, 9:00AM to 5:30PM
<br>
<br>
Working Relationships: Must be able to communicate well both verbally and in writing with internal and external clients<p></p><div><div><div><div><div><div><div><p><b><br>
Qualifications</b></p></div></div></div></div></div></div></div>
Requirements: BA or BS Minimum of 1-3 years of work experience, clinical research experience helpful Must be knowledgeable about computers and data management systems and familiar with common software packages (Word, Excel, PowerPoint, Access, Outlook) and Internet communication Familiarity with statistical packages (SPSS, SAS) desirable Must have the capability of prioritizing multiple competing tasks and seek supervisory or administrative assistance when appropriate<p></p><div><div><div><div><div><div><div><p><b><br>
Additional Job Details (if applicable)</b></p></div></div></div></div></div></div></div><p></p><div><div><div><div><div><div><div><p><b><br>
Remote Type</b></p></div></div></div></div></div></div></div>
Hybrid<p></p><div><div><div><div><div><div><div><p><b><br>
Work Location</b></p></div></div></div></div></div></div></div>
15 New Chardon Street<p></p><div><div><div><div><div><div><div><p><b><br>
Scheduled Weekly Hours</b></p></div></div></div></div></div></div></div>
40<p></p><div><div><div><div><div><div><div><p><b><br>
Employee Type</b></p></div></div></div></div></div></div></div>
Regular<p></p><div><div><div><div><div><div><div><p><b><br>
Work Shift</b></p></div></div></div></div></div></div></div>
Day (United States of America)<p></p><p><b><br>
Pay Range</b></p>
$63,252.80 - $102,596.00/Annual<p></p><p><b><br>
Grade</b></p>
7<br>
<p></p>
At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.<p></p><div><div><div><div><div><div><div><p><b><br>
EEO Statement:</b></p></div></div></div></div></div></div></div>
1200 The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran&rsquo;s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.<p></p><h2 class="jobSectionHeader"><b><br>
Mass General Brigham Competency Framework</b></h2><div><div><p>
At Mass General Brigham, our competency framework defines what effective leadership &ldquo;looks like&rdquo; by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.</p></div></div></div>

Clinical Trial Assistant Project Manager

Dana-Farber Cancer Institute

<div><div><div><div>Job Ref:</div><div>
JR-3898</div></div><br>
<div><div>Location:</div><div>
450 Brookline Ave, BOSTON, MA 02215</div><br>
</div>
<div><div>Category:</div><div>
Clinical Research</div></div><br>
<div><div>Employment Type:</div><div>
Full time</div></div><br>
<div><div>Work Location:</div><div>
Remote: 100% off site</div></div><br>
<div></div><div><div>Salary/Pay Rate:</div><div>
$70,000.00 - $85,300.00 per year</div>
</div></div><p><b>Overview</b></p>
<p></p><div><div>This Assistant Clinical Research Manager (ACRM) position will work within the Breast Oncology clinical research program and assist in the management of the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator. These positions, in collaboration with the program&rsquo;s Clinical research Managers physicians and research nursing staff, are responsible for assisting with the design, implementation and evaluation of their program&rsquo;s clinical research activities, related regulatory oversight, and will provide day to day supervision of their program&rsquo;s clinical research staff as needed.<p>
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.</p><p><b><br>
Clinical Trials Operations
</b></p><ul><li><p>Assistant Clinical Research Managers (ACRM) will be responsible for assisting the Clinical Research Manager with the oversight of their disease group&rsquo;s clinical trial portfolio and all related regulatory and compliance requirements.</p></li><li><p>
The ACRM will assist the CRM will all aspects of study start up, active and close out activities for the group&rsquo;s portfolio. They will be responsible for the required tracking of all protocol development, submission, review and approval milestones.</p></li><li><p>
The ACRM will assist with the oversight of subject enrollment, protocol treatment and follow-up care processes for protocol patients.</p></li><li><p>
Assist with the oversight of registration of protocol patients, study group registrar and pharmaceutical company as outlined in protocol.</p></li></ul><p><b>
Regulatory &amp; Compliance
</b></p><ul><li><p>Assists in the responsibility for essential document compliance for entire portfolio. Implements systems to monitor and ensure regulatory document collection and maintenance compliance.</p></li><li><p>
Assists in the responsibilities for all clinical trial reporting requirements; safety event, annual approval, deviations etc. May implement systems to monitor portfolio compliance.</p></li><li><p>
Assists the study team to be maintain an &ldquo;audit ready&rdquo; research environment
</p></li></ul><p><b>Data Management &amp; Clinical Trial Monitoring
</b></p><ul><li><p>Assists CRM with responsibility for data management and compliance for entire portfolio. Maintains schedules and procedures necessary for timely and complete data collection.</p></li><li><p>
Regularly reports data compliance status to key stakeholders; i.e. DFCI PI, study Sponsor, DFCI CTO. Helps to implement corrective action to maintain data compliance when necessary.</p></li><li><p>
Submits required &ldquo;progress / tracking &ldquo;reports to key stakeholders, when applicable.</p></li></ul><p><b>
Staff Training &amp; Development</b></p><ul><li><p>
Will assist the CRM with the recruitment and oversight of coordinator staff as well as ensures that staff have completed mandatory training in a timely manner.</p></li><li><p>
Will help implement program specific on-boarding and orientation process and may participate in annual performance evaluations and competency assessments of research staff as needed.</p></li></ul><p><b>
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
</b></p><ul><li><p>Must be able to perform day-to-day responsibilities independently with minimal supervision from managers.</p></li><li><p>
Has the ability to identify regulatory scenarios that require consultation.</p></li><li><p>
Has a good understanding of clinical trials start-up, active and close out phases.</p></li><li><p>
Has a good understanding of clinical research, local policy and federal regulation.</p></li><li><p>
Knowledge of cancer as a disease process, cancer treatment modalities, and the clinical trial process.</p></li><li><p>
In addition, has experience in protocol development, data compilation and analysis.</p></li><li><p>
The ACRM will have a good understanding of the various tracking systems used to ensure timely data management by the clinical research staff.</p></li><li><p>
They will also understand Federal and State regulations as they relate to research. Strong interpersonal, organizational and communication skills are required.</p></li><li><p>
Must have computer skills including the use of Microsoft Office.</p></li></ul><p><b>
MINIMUM JOB QUALIFICATIONS:
</b></p><ul><li><p>Bachelor&rsquo;s Degree required.</p></li><li><p>
Minimum of 3 plus years of related experience preferred.</p></li><li><p>
Must have the ability to function independently, think critically and with good professional judgment.</p></li></ul><p><b>
License/Certification/Registration:</b> N/A</p><p><b>
SUPERVISORY RESPONSIBILITIES:</b> No direct report</p><ul><li><p>
Will provide day to day supervision for study management staff, including clinical research coordinators, students, volunteers, and other research assistants as needed.</p></li></ul><p><b>
PATIENT CONTACT: </b>May have contact with patients of all ages and populations.</p><p>
At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and when it comes to hiring the most dedicated and compassionate professionals, neither do we. If working in this kind of organization inspires you, we encourage you to .</p><p>
Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.
</p><h3 class="jobSectionHeader"><b>EEO Poster</b></h3>
.<p>
Pay Transparency Statement</p><p>
The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate&rsquo;s relevant experience, skills and qualifications.</p><p>
For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA).</p>
$70,000.00 - $85,300.00</div></div></div><p></p>

Assistant Clinical Research Manager - Breast Oncology Clinical Trials

<div><div><div><div>Job Ref:</div><div>
JR-3297</div></div><br>
<div><div>Location:</div><div>
450 Brookline Ave, BOSTON, MA 02215</div><br>
</div>
<div><div>Category:</div><div>
Clinical Research</div></div><br>
<div><div>Employment Type:</div><div>
Full time</div></div><br>
<div><div>Work Location:</div><div>
Onsite: 100% onsite</div></div><br>
<div></div><div><div>Salary/Pay Rate:</div><div>
$48,100.00 - $54,400.00 per year</div>
</div></div><p><b>Overview</b></p>
<p></p><div><div>The CRC (Clinical Research Coordinators) work within the clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator and the Clinical Research Manager. The CRC will be responsible for the primary data collection and management of patient clinical information as it pertains to participation in clinical trials. Ensures timely facilitation of trial assessments per protocol and collection of protocol related samples including shipment to outside entities as required. Will support and maintain participant/subject trial binders and may maintain regulatory binders, to ensure study compliance with all state, federal, and IRB requirements. May be responsible for pertinent IRB protocol submissions. This individual may also screen patients for protocol eligibility, obtain informed consent for non-treatment trials, and register study participants with the clinical trials management system, ONCORE. Some travel may be required.<br>
<br>
This position is considering 2026 bachelor&rsquo;s degree graduates.<p>
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.</p><br>
<ul><li>
Oversight of the clinical trials start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities.</li><li>
Responsible for data reporting and management, collection of source documents, use and development of case report forms, adverse events reporting, filing, and archiving of study records, and resolution of data queries.</li><li>
May prepare and or complete regulatory related reports and IRB submissions. Maintain and organize study participant/subject trial binder and regulatory binders, enter all required study data on an ongoing basis and as applicable.</li><li>
Ensure all study related samples are collected, properly prepared, and shipped according to the protocol requirements and IATA/DOT regulations.</li><li>
Collaborate with other departments such as Protocol Scheduling, Materials Management, the Clinical Research Laboratory, Pharmacy, Research Nursing, and other departments, as needed per the requirements of the clinical trial.</li><li>
Responsible for organizing and preparing for both internal and external auditing and study monitoring visits.</li><li>
Coordination and management of clinical trials throughout the trial life cycle, including communication with sponsors and regulatory authorities.</li><li>
Close-out of clinical trials, including contributing to research articles, audit preparation, and communication with regulatory agencies and other disciplines involved.</li><li>
Interact with study participants as directed/required by the protocol and/or study team.</li><li>
May be responsible for tissue sample collection per trial requirements.</li><li>
Responsible for data entry of Subject Visit Tracking information into Clinical Trial Management System contemporaneously with medical visits, assessments, and other subject-specific information.</li><li>
Responsible for data entry of time and effort spent on study-specific activities and other administrative tasks into Clinical Trial Management System contemporaneously with work completed.</li><li>
Responsible for data entry of study-specific activity, including but not limited to monitor visits, external site enrollment, amendments, receipt of Safety Reports, etc. into Clinical Trial Management System contemporaneously with activity completed.</li></ul><p><b>
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:</b></p><ul><li>
Excellent organization and communications skills required.</li><li>
Strong interpersonal skills &ndash; ability to effectively interact with all levels of staff and externals contacts.</li><li>
Must be detail oriented and have the ability to follow-through.</li><li>
Ability to effectively manage time and prioritize workload.
</li><li>Must practice discretion and adhere to hospital confidentiality guidelines at all times.</li><li>
Must have computer skills including the use of Microsoft Office.</li></ul><p><b>
MINIMUM JOB QUALIFICATIONS:
</b></p><ul><li>Bachelor&rsquo;s Degree or 1 year of Dana-Farber Associate Clinical Research Coordinator experience required. 0-1 years of experience working in a medical or scientific research setting or comparable technology orientated business environment preferred.
</li></ul><p><b>SUPERVISORY RESPONSIBILITIES: None</b></p><p><b>
PATIENT CONTACT:
</b></p><p><b>All positions: </b>May have contact with Adult and Pediatric patients of all ages and populations. May distribute protocol schedules, quality of life surveys or other study-related questionnaires, subject diaries, and/or conduct follow-up communication with patients</p><p>
At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and when it comes to hiring the most dedicated and compassionate professionals, neither do we. If working in this kind of organization inspires you, we encourage you to .</p><p>
Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.
</p><h3 class="jobSectionHeader"><b>EEO Poster</b></h3>
.<p>
Pay Transparency Statement</p><p>
The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate&rsquo;s relevant experience, skills and qualifications.</p><p>
For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA).</p>
$48,100.00 - $54,400.00</div></div></div><p></p>

Clinical Research Coordinator - GU Oncology

<div><div><div><div>Job Ref:</div><div>
JR-1785</div></div><br>
<div><div>Location:</div><div>
450 Brookline Ave, BOSTON, MA 02215</div><br>
</div>
<div><div>Category:</div><div>
Clinical Research</div></div><br>
<div><div>Employment Type:</div><div>
Full time</div></div><br>
<div><div>Work Location:</div><div>
Onsite: occasional remote</div></div><br>
<div></div><div><div>Salary/Pay Rate:</div><div>
$48,100.00 - $54,400.00 per year</div>
</div></div><p><b>Overview</b></p>
<p></p><div><div>The Clinical Research Coordinator (CRC) will work within the Breast Oncology clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator. The CRC will be responsible for the primary data collection and management of patient clinical information as it pertains to participation in clinical trials. Ensures timely collection of protocol related samples including shipment to outside entities as required. Maintains regulatory binders and ensures study compliance with all state, federal, and IRB requirements. May be responsible for IRB protocol submissions (amendments, continuing reviews, and minimal risk protocols). This individual may also screen patients for protocol eligibility, obtain informed consent, and register study participants with the Quality Assurance Office for Clinical Trials (QACT). Some travel may be required.<p>
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.</p><br>
<ul><li>
Oversight of the clinical trials start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities.</li><li>
Responsible for data reporting and management, collection of source documents, use and development of case report forms, adverse events reporting, filing, and archiving of study records, and resolution of data queries.</li><li>
May prepare and or complete regulatory related reports and IRB submissions. Maintain and organize study participant/subject trial binder and regulatory binders, enter all required study data on an ongoing basis and as applicable.</li><li>
Ensure all study related samples are collected, properly prepared, and shipped according to the protocol requirements and IATA/DOT regulations.</li><li>
Collaborate with other departments such as Protocol Scheduling, Materials Management, the Clinical Research Laboratory, Pharmacy, Research Nursing, and other departments, as needed per the requirements of the clinical trial.</li><li>
Responsible for organizing and preparing for both internal and external auditing and study monitoring visits.</li><li>
Coordination and management of clinical trials throughout the trial life cycle, including communication with sponsors and regulatory authorities.</li><li>
Close-out of clinical trials, including contributing to research articles, audit preparation, and communication with regulatory agencies and other disciplines involved.</li><li>
Interact with study participants as directed/required by the protocol and/or study team.</li><li>
May be responsible for tissue sample collection per trial requirements.</li><li>
Responsible for data entry of Subject Visit Tracking information into Clinical Trial Management System contemporaneously with medical visits, assessments, and other subject-specific information.</li><li>
Responsible for data entry of time and effort spent on study-specific activities and other administrative tasks into Clinical Trial Management System contemporaneously with work completed.</li><li>
Responsible for data entry of study-specific activity, including but not limited to monitor visits, external site enrollment, amendments, receipt of Safety Reports, etc. into Clinical Trial Management System contemporaneously with activity completed.</li></ul><p><b>
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:</b></p><ul><li>
Excellent organization and communications skills required.</li><li>
Strong interpersonal skills &ndash; ability to effectively interact with all levels of staff and externals contacts.</li><li>
Must be detail oriented and have the ability to follow-through.</li><li>
Ability to effectively manage time and prioritize workload.
</li><li>Must practice discretion and adhere to hospital confidentiality guidelines at all times.</li><li>
Must have computer skills including the use of Microsoft Office.</li></ul><p><b>
MINIMUM JOB QUALIFICATIONS:
</b></p><ul><li>Bachelor&rsquo;s Degree or 1 year of Dana-Farber Associate Clinical Research Coordinator experience required. 0-1 years of experience working in a medical or scientific research setting or comparable technology orientated business environment preferred.
</li></ul><p><b>SUPERVISORY RESPONSIBILITIES: None</b></p><p><b>
PATIENT CONTACT:
</b></p><p><b>All positions: </b>May have contact with Adult and Pediatric patients of all ages and populations. May distribute protocol schedules, quality of life surveys or other study-related questionnaires, subject diaries, and/or conduct follow-up communication with patients</p><p>
At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and when it comes to hiring the most dedicated and compassionate professionals, neither do we. If working in this kind of organization inspires you, we encourage you to .</p><p>
Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.
</p><h3 class="jobSectionHeader"><b>EEO Poster</b></h3>
.<p>
Pay Transparency Statement</p><p>
The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate&rsquo;s relevant experience, skills and qualifications.</p><p>
For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA).</p>
$48,100.00 - $54,400.00</div></div></div><p></p>

Clinical Research Coordinator - Breast Oncology

Alliance for Clinical Trials in Oncology

<div>
 <p>
  The Alliance for Clinical Trials in Oncology Foundation (Foundation) is a foundation created to enhance and expand the ability of the Alliance for Clinical Trials in Oncology (Alliance) to conduct cancer clinical research and address important treatment questions through large-scale clinical trials. Through efforts of the Foundation in support of the Alliance, clinical trials and laboratory research are conducted to discover new or improved ways to prevent, treat, and cure many types of cancer, including leukemia and lymphoma, and cancers of the breast, prostate, lung, and gastrointestinal (GI) tract, and help educate the medical community on methods of cancer diagnosis, treatment, and prevention.
 </p>
 <p>
  In May 2014, the Foundation created the Alliance Foundation Trials, LLC (AFT), respectively, a wholly-owned subsidiary of the Foundation. AFT was also created to conduct cancer clinical research and address medical care and treatment through large-scale clinical trials involving various industry-related partners.
 </p>
 <p>
  The Alliance Foundation Trials (AFT) is seeking a Clinical Research Associate (CRA) to support the management and execution of clinical trial operations across AFT studies. This role is responsible for key site management and study start-up activities, including feasibility assessments, site selection support, maintenance of trial master files (eTMF), and oversight of clinical trial systems such as CTMS. The CRA will collaborate closely with CROs, vendors, and investigative sites to ensure studies are conducted in compliance with ICH GCP guidelines and organizational standards, while supporting studies from start-up through ongoing maintenance. Come join an organization full of passionate, team-oriented professionals driven to change the face of cancer.
 </p>
 <p>
  Benefits of working at the Alliance for Clinical Trials in Oncology Foundation{{:}}
 </p>
 <ul>
  <li>
   8 weeks of paid time off (including PTO, sick, and holidays) during year one
  </li>
  <li>
   Medical, Dental &amp; Vision plans with a 100% employer-paid option for employees
  </li>
  <li>
   Tuition reimbursement stipends
  </li>
  <li>
   Continuing Education
  </li>
  <li>
   3% employer match for retirement investments
  </li>
  <li>
   Annual Employee Performance Bonus Program
  </li>
  <li>
   Annual Cost of Living Adjustment
  </li>
  <li>
   50% commuter reimbursement
  </li>
  <li>
   Healthy Work/Life balance and flexibility
   <br/>
  </li>
 </ul>
 <p>
  <strong>
   ROLE AND RESPONSIBILITIES
  </strong>
 </p>
 <p>
  &bull; Assist operations team in supporting the Alliance member sites and escalate site related issues when necessary.
 </p>
 <p>
  &bull; Send, track, and review study-specific and global feasibility questionnaires.
 </p>
 <p>
  &bull; Assist with site selection and recruitment by generating site identification reports (e.g., site accrual); collecting, reviewing and tracking site feasibility/credentialing documentation and follow-up on site accruals accordingly.
 </p>
 <p>
  &bull; Track training information and issue trainings for sites and contacts.
 </p>
 <p>
  &bull; Collection of essential documents related to study start-up and review IP release packages.
 </p>
 <p>
  &bull; Prepare for and execute Investigator meetings and other site training programs.
 </p>
 <p>
  &bull; Assist with creation of start-up plans and templates.
 </p>
 <p>
  &bull; Ensure proper and timely filing of all relevant study documents into the eTMF on an ongoing basis to ensure compliance with applicable work instructions, SOPs and ICH GCP guidelines and AFT expectations.
 </p>
 <p>
  &bull; Perform routine review of filing procedures to ensure adherence to current quality guidelines at all times.
 </p>
 <p>
  &bull; Accurately enter and manage data within the Clinical Trial Management System (CTMS) by{{:}} tracking completed training information that could carry over to other studies; maintaining site information and rosters; reviewing monitoring reports to identify deficiencies, reviewing adequacy of issue escalation and issue resolution; and provide feedback to appropriate CRO contacts.
 </p>
 <p>
  &bull; Participate in co-monitoring activities.
 </p>
 <p>
  &bull; Communicate with CROs, vendors, and/or study sites as necessary to support the study, which includes monitoring email accounts related to studies.
 </p>
 <p>
  &bull; Conduct regulatory review of ICF changes and coordinate review by Executive Officer and contracts team
 </p>
 <p>
  &bull; Coordinate study related meetings; take detailed minutes at meetings on decisions and action items and distribute to the team, as assigned.
 </p>
 <p>
  &bull; Other related duties as assigned to meet departmental and company objectives.
  <br/>
  <br/>
 </p>
 <strong>
  Requirements
  <br/>
  <br/>
 </strong>
 <p>
  <strong>
   QUALIFICATIONS AND EDUCATION REQUIREMENTS
  </strong>
 </p>
 <p>
  &bull; A minimum of a BA/BS degree is required.
 </p>
 <p>
  &bull; Degree in a health or science major preferred.
 </p>
 <p>
  &bull; 2 - 4 years relevant experience in biotech, pharma, and/or CRO, including 1 year of clinical research industry experience.
 </p>
 <p>
  &bull; Working knowledge of clinical monitoring responsibilities and procedures.
 </p>
 <p>
  &bull; Previous experience with eTMF, CTMS, and IRT clinical trial systems is strongly preferred.
 </p>
 <p>
  &bull; Proficient in Microsoft Office Suite, especially Word and Excel.
 </p>
 <p>
  <strong>
   PREFERRED SKILLS
  </strong>
 </p>
 <p>
  &bull; Strong organizational skills and ability to prioritize workload to meet tight deadlines in a fast-paced and dynamic work environment.
 </p>
 <p>
  &bull; Strong interpersonal, written, and verbal communication skills.
 </p>
 <p>
  &bull; Flexible and adaptable to a small business workplace environment.
 </p>
</div>


Clinical Research Associate

Boston Children's Hospital

<p>84924BR<br/></p><p>Urology<br/></p><p>Job Posting Description<br/></p><p>Position Summary:<br/>Under direction of the Principal Investigator and/or designee, independently carries out studies. Responsible for screening patients for trial participation, enrolling patients, monitoring protocol implementation, completing required forms, reporting results and regulatory submission. Creates study-specific data collection and statistical and analytical reports. Responsible for managing and coordinating the clinical studies as members of the research team and will work closely with multidisciplinary teams and participate in subject research activities throughout the studies. May assist in writing articles and summarizing papers for submission.<br/></p><p>Key Responsibilities:<br/>Responsible for daily operations of the study. Implements processes and procedures to meet study goals and protocol requirements. May participate in training Clinical Research Assistants and prepare study related training materials as needed in collaboration with the Principal Investigator and/or designee.<br/>Consents and enrolls patients for studies by providing detailed information on the clinical study to prospective participants and families. Is responsible for understanding and adhering to all policies and procedures and responds to all inquiries. Evaluates the suitability of study candidates and makes selections based on clinical knowledge of each study. Provides input for updates of SOPs and drafting of new quality documentation.<br/>Coordinates and prepares with minimal supervision the necessary documentation for Institutional Review Board (IRB) and external stakeholders on submissions and track progress to review and approval.<br/>May prepare, monitor, and justify project budgets according to hospital and funding agency specifications. Monitors expenses and identifies and resolves errors or discrepancies. May maintain financial records and prepare related reports. For multi-center studies, performs subrecipient monitoring to ensure timely invoicing and progress according to schedule.<br/>Serves as liaison between local study sites and Clinical Coordinating Center regarding study procedures and operations and protocol interpretation. Ensures on site and subcontract operations are consistent with overall study requirements for database maintenance, coding, completion and computer input of study forms, deadlines and other related issues. Maintains regulatory binders and all study documentation, monitors adverse events and reporting thereof, handles protocol amendments and continuing reviews.<br/>Creates tracking systems and assist with developing processes to enhance efficiency and effectiveness of study operations and data management, such as patient appointment scheduling, and completion and tracking of study data and forms.<br/>Create and prepare data collection statistical reports and analytical summaries for distribution to the study research team for review and analysis. May write articles and summaries of studies for submission. May present study results at local and national meetings.<br/>Assists PIs in preparing new applications for research funding and in developing, implementing, and managing ancillary study grants. Assists in preparing scientific abstracts and manuscripts for publication in academic journals.<br/></p><p>Minimum Qualifications<br/>Education:<br/>A Bachelor&rsquo;s Degree is required, Master&rsquo;s Degree preferred.<br/>Experience:<br/>A minimum of 2 years of relevant experience is required.<br/>Experience with RedCap and EPIC is preferred.<br/></p><p>Status<br/></p><p>Full-Time<br/></p><p>Regular, Temporary, Per Diem<br/></p><p>Regular<br/></p><p>Standard Hours per Week<br/></p><p>40<br/></p><p>Pay Range<br/></p><p>$44657.60-$69773.60 Annual<br/></p><p>Office/Site Location<br/></p><p>Boston<br/></p><p>Job Posting Category<br/></p><p>Research<br/></p><p>Remote Eligibility<br/></p><p>Part Remote/Hybrid<br/></p>

Clinical Research Coordinator

Joslin Diabetes Center

<div>Overview:
<div>
The<b> Clinical Research Coordinator</b>&rsquo;s responsibilities may be associated with one or more clinical research project(s). The Coordinator works directly with pediatric patients and their families, and is responsible for coordinating assigned study/studies.</div><div></div><div><i><br>
As a health care organization, we have the responsibility to do everything in our power to care for and protect our patients, our colleagues and our communities. We require that all staff be vaccinated against influenza (flu) as a condition of employment.</i></div>
Responsibilities:
<ul><li>In all activities, adhere to Good Clinical Practice guidelines and maintain patient confidentiality per HIPAA regulations</li><li>
Identify potentially eligible participants using appropriate data sources</li><li>
Assess eligibility of potential study participants</li><li>
Become familiar with relevant content of all relevant study protocols</li><li>
Communicate clinical trial updates to other team members</li><li>
Describe studies to potential participants, explain rationale for and details of participation</li><li>
Obtain informed consent and assent, when appropriate</li><li>
Schedule study visits and prepare relevant materials for each visit (tubes, paperwork, etc.)</li><li>
Arrange participant travel, as applicable</li><li>
Collect primary data from study participants and their guardians</li><li>
After completing training, measure vital signs and perform other relevant procedures and tests</li><li>
Ensure that study visits and source documents are completed in accordance with study protocols, including verifying the work of other staff members</li><li>
Enter data into electronic data capture forms and respond to queries</li><li>
Process laboratory samples and ship to central laboratories</li><li>
Ensure timely reporting of abnormal findings to investigator and participants</li><li>
Document and communicate all serious adverse events and other safety reports to the study team and investigator</li><li>
Maintain up-to-date inventory of study supplies and place orders</li><li>
Modify study documents, such as informed consent form and recruitment materials, when needed</li><li>
Prepare documents for submission to IRB&mdash;may include initial protocol submissions, protocol amendments, annual continuing review, etc.</li><li>
Maintain all regulatory and subject binders in audit-ready condition</li><li>
Correspond with study sponsors, contract research organizations, and other collaborators, as applicable</li><li>
Assist with study start-up and close-out activities, as relevant</li><li>
Participate in study teleconferences, attend team meetings, and attend national meetings and/or investigator meetings, as relevant (may involve travel)</li><li>
Participate in occasional off-site recruitment events (requires some schedule flexibility)</li><li>
Other duties as assigned.</li></ul>
Qualifications:
<ul><li>Bachelor&rsquo;s degree (in a relevant field of study preferred)</li><li>
1-2 years of relevant post-graduate experience preferred</li><li>
Fluency in written and spoken English</li><li>
Spoken Spanish preferred</li><li>
Basic knowledge of Microsoft Office Suite and ability to navigate at a basic level within various web-based applications.</li><li>
Graphic design/layout skills (to design brochures, flyers, etc.) desirable</li><li>
Ability to follow general instructions and procedures, as provided.</li><li>
Strong interpersonal, organizational and communication skills (communicate clearly and effectively via verbal and written instruction).</li><li>
Meticulous attention to detail</li><li>
Professional and warm in demeanor, especially when relating to study participants and their families</li><li>
Ability to maintain confidentiality</li><li>
Ability to prioritize responsibilities &ndash; through completion.</li><li>
Ability to work independently and with others in the team - to interact respectfully with other employees, professional staff and/or external contacts.</li><li>
Excellent critical thinking and problem-solving abilities</li><li>
Ability to learn sophisticated concepts and detailed protocols quickly</li><li>
Ability to work with minimal oversight, after training period</li><li>
Ability to manage administrative complexity arising from multiple concurrent studies</li><li>
Flexible schedule as necessary to accommodate study patients and recruitment activities</li></ul><div></div><div><br>
The pay range listed for this position is the base hourly wage range the organization reasonably and in good faith expects to pay for this position at this time. Actual compensation is determined based on several factors, that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other applicable factors permissible by law. Compensation may exceed the base hourly rate depending on shift differentials, call pay, premium pay, overtime pay, and other additional pay practices, as applicable to the position and in accordance with the law.</div>
(Min): USD $21.64/Hr. (Max): USD $24.37/Hr.</div>

Clinical Research Coordinator I

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