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clinical research coordinator ii

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associate director clinical research program breast oncology

Dana-Farber Cancer Institute

<div><div><div><div>Job Ref:</div><div>
JR-3473</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: occasional onsite</div></div><br>
<div></div><div><div>Salary/Pay Rate:</div><div>
$129,500.00 - $150,200.00 per year</div>
</div></div><p><b>Overview</b></p>
<p></p><div><div>The Associate Director, Clinical Research Program will oversee all Breast Oncology clinical trials and translational research operations, regulatory and compliance within the assigned program(s).<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><ul><li><p><br>
Oversee and organize recurring meetings for translational and clinical trials research, disease specific projects, portfolio review, and budget</p></li><li><p>
Oversee in collaboration with leadership, institutional clinical research priorities, goals and key performance indicators</p></li><li><p>
Able to act fully autonomously, to execute high level decisions independently with little or no supervision and to consistently formulate solutions to complex situations.</p></li><li><p>
Oversee Clinical Research Managers, including Translational Program Manager, Assistant Research Manager(s) and indirect supervision of Regulatory Operations Manager and support staff. Support Research Manager(s) in recruiting and hiring staff</p></li><li><p>
Support portfolio, low accrual trial monitoring system, and Workload/Resource Utilization Tool development incorporating feedback from investigators and Clinical Trials management platforms, tracker and roadmaps.</p></li><li><p>
Oversee investigator-initiated and grant funded clinical trials including development of protocols/budgets, support the contract process, and coordinate correlative sample processing</p></li><li><p>
Lead process improvement projects to increase accrual and study approval/activation timelines</p></li><li><p>
Lead process improvement projects to increase consent and collection rates</p></li><li><p>
Support for Clinical Research Manager, Regulatory Operations Manager, CTO Project Manager(s) in operationalizing the Portfolio Workload Tool with direct supervision from the CTO</p></li><li><p>
Support Clinical Research Manager, Regulatory Operations Manager, and Translational Research Manager in recruiting and hiring new Clinical Research Coordinators, Regulatory Coordinators, and Research Data Specialists</p></li><li><p>
Liaise with Clinical Research finances including federal, philanthropic, foundation, and industry funding sources</p></li><li><p>
Facilitate communication with the Research Administrators, Grants &amp; Contracts, CTBO, and other internal groups</p></li><li><p>
Engage in strategic financial planning in collaboration with department leaders</p></li><li><p>
Mentor staff program to promote growth within the research program</p></li><li><p>
Monitor clinical research staff allocations and staff satisfaction</p></li><li><p>
Support staff responsible for larger initiatives include translational coordinators and project/program managers.</p></li></ul><p><b>
MINIMUM JOB QUALIFICATIONS:
</b></p><ul><li><p>Bachelor's degree in a field relevant to research compliance required, Master&rsquo;s degree or higher preferred.</p></li><li><p>
10 years of increasing expertise and responsibility in regulatory and clinical trials required; 5 years with advanced degree.</p></li><li><p>
Previous experience in the conduct of clinical trials and research operations required.</p></li><li><p>
Experience in US drug and biologics regulations and an excellent understanding of clinical trial processes and research operations required.</p></li></ul><p><b>
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
</b></p><ul><li><p>Knowledge of ICH GCP practices and clinical trial designs.</p></li><li><p>
Full functional knowledge of FDA regulations relevant to the development and approval of new therapeutic agents, biologics, vaccines, and medical devices.</p></li><li><p>
Comprehensive knowledge of regulatory requirements (regulations, directives, and guidance/guidelines) pertaining to the development and registration of drug products in US.</p></li></ul><p><b>
SUPERVISORY RESPONSIBILITIES:</b></p><ul><li><p>
Directly supervises Clinical Research Manager, Translational Program Manager; indirectly manages and/or supports other translational and clinical research staff (e.g., Assistant Clinical Research Managers, Research Project Managers, Research Program Managers, Research Data Specialists, Clinical Research and Regulatory Operations Managers, Clinical Research Coordinators, etc.).</p></li></ul><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>
$129,500.00 - $150,200.00</div></div></div><p></p>

Associate Director, Clinical Research Program - 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

<div><div><div><div>Job Ref:</div><div>
JR-3436</div></div><br>
<div><div>Location:</div><div>
450 Brookline Ave, BOSTON, MA 02215</div><br>
</div>
<div><div>Category:</div><div>
Research Laboratory</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>
$50,500.00 - $56,700.00 per year</div>
</div></div><p><b>Overview</b></p>
<p></p><div><div>The Research Data Specialists will support the Breast Oncology clinical research program in the areas of data collection, computing, and database organization. Duties include the examination, synthesis, and evaluation of medical records; the abstraction and recording of pertinent medical information; and the monitoring of patient status. The Clinical Research Data Specialist will be responsible for the collection, management, and quality assurance review of patient clinical data.<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><ul><li><p><br>
Disease Based RDS positions:</p></li><li><p>
Responsible for reviewing and abstracting the medical records for research patients on trials they are assigned</p></li><li><p>
Entering identified clinical data points in the corresponding database</p></li><li><p>
Ensuring that data is entered within the outlined timelines for each trial</p></li><li><p>
Assisting research teams with the development, testing and implementation of Case Reports Forms for PI-Initiated clinical trials.</p></li><li><p>
CRIS RDS positions:</p></li><li><p>
Evaluating and tracking the eligibility of all patients seen in the clinic for inclusion in the study</p></li><li><p>
May assist or be responsible for consenting eligible patients in clinic</p></li><li><p>
Maintaining on-going communications with Information Services and physicians and staff for data collection needs</p></li><li><p>
Reviewing and abstracting the medical records for patients. Entering the clinical data into the Clinical Research Information Systems (CRIS)</p></li><li><p>
Accessing patient demographic and clinical information from the clinical systems. Entering information into the database</p></li><li><p>
Reviewing data for quality and completeness using reporting software</p></li><li><p>
Collaborating with principal investigators, IS staff, and clinic staff in the continued development of the CRIS system</p></li><li><p>
Assist principal investigators and staff in the creation of data reports for quality assurance measures</p></li><li><p>
Coordinates the collection, processing, organization, and storage of biological specimens including maintenance of electronic specimen tracking systems (STIP) and laboratory binders</p></li><li><p>
May be responsible for IRB and regulatory submissions and maintenance of regulatory files</p></li><li><p>
Bone Marrow Transplant (BMT) RDS positions:</p></li><li><p>
Support the clinical programs with outcomes data collection, reporting, analysis and audits</p></li><li><p>
Ensures timely reporting to internal and external outcomes data repositories, including national repositories when required by regulatory requirements and U.S. law</p></li><li><p>
Ensure case management documentation in patient medical records and other information management systems as assigned to support clinical program clinical care</p></li><li><p>
Perform QA and QC procedures to ensure optimal data reporting as assigned</p></li><li><p>
Develop knowledge of specialized data sources specific to outcomes data reporting, including routine reaching out to offsite providers to obtain information from medical records at outside sites of care</p></li></ul><p><b>
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:</b></p><ul><li><p>
Excellent organizational and communication skills required</p></li><li><p>
Strong interpersonal skills &ndash; ability to effectively interact with all levels of staff and external contacts.</p></li><li><p>
Must be detail oriented</p></li><li><p>
Ability to effectively manage time and prioritize workload</p></li><li><p>
Must practice discretion and always adhere to institutional confidentiality guidelines</p></li><li><p>
Must have computer skills including the use of Microsoft Office</p></li></ul><p><b>
MINIMUM JOB QUALIFICATIONS:</b></p><p>
The position requires a bachelor&rsquo;s degree or 1 year of experience as a Dana-Farber Associate Research Data Specialist. Experience of 0-1 years in a medical, scientific research, or technology-oriented business environment is preferred.</p><p><b>
SUPERVISORY RESPONSIBILITIES:</b> None</p><p><b>
PATIENT CONTACT:
</b></p><p>Yes, all ages.</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>
$50,500.00 - $56,700.00</div></div></div><p></p>

Research Data Specialist - Breast Oncology Clinical Trials

<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

The Brigham and Women's Hospital, Inc.

<div>Site: The Brigham and Women's Hospital, Inc.<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><br>
<p></p>
NURSE PRACTITIONER, MS/PART TIME/30 HOURS/ROTATING SHIFT/BWH ONCOLOGY INFUSION DEPARTMENT<br>
<br>
INFUSION APP JOB POSTING ADDENDEUM
<br>
The Oncology Infusion Department is seeking a part-time (30 hours/week) Nurse Practitioner to join the Infusion Center team at Brigham and Women&rsquo;s Hospital. The Infusion APP will work within our adult Oncology and Medical Infusion Center(s) to serve as an infusion first responder, promote infusion service access and efficiency and may provide urgent care/symptom management in close collaboration with longitudinal medicine providers.
<br>
<br>
The APP work location include, but not limited to Main Campus Boston, 850 Boylston in Chestnut Hill and other off-site locations, and to be determined by clinical staffing needs.
<br>
<br>
PRIMARY RESPONSBILITIES:<br>
<ul><li>The APP will work closely with oncology primary teams to engage in the care of patients with complex diagnoses, serving as a first responder for acute reactions and medical emergencies within the infusion department.
</li><li>Works collaboratively with longitudinal oncology and medical teams and nursing staff to ensure continuity of care across the care continuum</li><li>Provides consultation to both nurses and providers to maintain and improve access to infusion services</li><li>Writes, modifies and addends orders in accord with current guidelines</li><li>Maintains and practices in accord with practitioner guidelines per state and hospital regulations</li><li>Serves in appropriate intra and interdepartmental committees</li><li>Collaborates with unit staff, Providers, Professional Development Managers, APP Leader, Nurse Director and other health care professionals to meet staff and patient educational needs</li><li>Monitors patient outcomes in accordance with defined standards of patient care</li><li>Facilitates patient movement through the system and efficient use of resources through interdepartmental collaboration</li><li>Supports educational efforts to advance knowledge and promote education-based practice</li><li>Evaluates own practice and program effectiveness</li><li>Responsible for own professional growth and maintenance of required credentials</li><li>Maintains the standards and educational requirements specific to the position and licensure</li></ul><p></p><p><b><br>
Job Summary</b></p>
Summary<br>
The Nurse Practitioner is an advanced practice registered nurse who has acquired specialized knowledge and skills through completion of a nurse practitioner program. The practitioner has the credentials to function in an expanded nursing role and is responsible for the daily management of selected patients. The practitioner has responsibility for the assessment and management of patients, including diagnostic and therapeutic interventions, and the continuous implementation and evaluation of an appropriate plan of care. The Nurse Practitioner works with their collaborating physician in accordance with mutually developed practice guidelines, members of the care team, and is responsible to the Nursing Director or Executive Nursing Director for the area for issues specific to the discipline of nursing.
<br>
<br>
Satisfactory completion of an approved formal education program that has as its objective the preparation of professional nurses to practice as nurse practitioners.<br>
<br>
ANA or other appropriate nursing certification in the area of practice and authorization by the Massachusetts Board of Registration in Nursing to practice in the expanded role. DEA for prescription writing.<br>
<br>
Working Conditions - Works in a variety of patient care environments where there may be exposure to communicable disease and hazardous materials.<br>
<br>
Does this position require Patient Care? Yes<br>
<br>
Essential Functions<br>
<ul><li>Patient Care Organization</li></ul>
1. Provides direct care, counseling, and teaching to a select patient population.<br>
2. Performs physical examinations and provides preventive health measures appropriate to patient needs.<br>
3. Orders, interprets, and evaluates appropriate lab and diagnostic tests to assess patients&rsquo; clinical problems and health care needs.<br>
4. Arranges for appropriate plan of care and follow-up based on outcome of diagnostic, lab, and physical assessment findings.<br>
5. Performs laboratory tests appropriate for specific patient population.<br>
6. Orders medications and writes prescriptions according to organizational and regulatory policies and procedures.<br>
7. Records pertinent patient care findings in the medical record.<br>
8. Sets priorities for appropriate and efficient management of patient care that reflects cost effective management of time, available human resources, supplies and equipment.<br>
9. Maintains interdisciplinary approach to planning and communicating patient care information by discussing patient data with appropriate physicians and other health care professionals.<br>
10. Incorporates the concepts of health maintenance, prevention, and promotion into daily practice through patient education and counseling.<br>
11. Demonstrates awareness of community resources and assists staff, patients, and families to effectively utilize them.
<br>
<br>
<ul><li>Quality of Care</li></ul>
1. Assists in the development, implementation and revision of nurse practitioner guidelines and monitoring requirements for prescription writing in collaboration with their designated physician and Nursing Director or Executive Nursing Director.
<br>
2. Evaluates outcomes of own patients&rsquo; care and makes necessary revisions in care plans.<br>
3. Seeks and provides consultative services as required.<br>
4. Participates in departmental and organization quality improvement program.<br>
5. Utilizes quality improvement data and research findings to enhance patient care.
<br>
<br>
<ul><li>Coordination</li></ul>
1. Demonstrates appropriate collaborative and consultative relationships with other providers within the institution and community.<br>
2. Serves on Nursing and Hospital Committees and assumes responsibility for disseminating and communicating information to staff.
<br>
<br>
<ul><li>Budget</li></ul>
1. Participates in setting productivity metrics and in cost-effective management of personnel, time, supplies, and equipment in their area.<br>
2. Collaborates with the Nursing Director/Practice Manager/Executive Nursing Director in the recommendation of appropriate staffing patterns for their clinical areas.
<br>
<br>
<ul><li>Personnel Management</li></ul>
1. Participates in selection process of new employees in group or team practice as requested.<br>
2. Provides input into evaluation of other staff as appropriate.
<br>
<br>
<ul><li>Education</li></ul>
1. Acts as preceptor for nursing students and staff as requested.<br>
2. Participates in orientation of new staff.<br>
3. Participates in Departmental and organization continuing education programs.<br>
4. Identifies own learning needs and updates clinical knowledge and skills through formal and informal education and review of current literature.<br>
5. Educates lay and/or professional groups through lectures, papers, publications, and educational materials.
<br>
<br>
<ul><li>Planning</li></ul>
1. Develops annual objectives and reviews with Nursing Director or Executive Nursing Director and collaborating M.D. at time of performance review and at appropriate intervals. Completes annual credentialing process through the Nursing Department credentialing program.<br>
2. Assists in determining, evaluating, and/or implementing clinical area goals and objectives.<br>
3. Maintains interdisciplinary approach for planning and communicating information for patient care and operation of practice.<br>
4. Maintains current knowledge of legislation that may affect the health care delivery system.<br>
5. Identifies and integrates patient population and/or disease state in programmatic goals and objectives.
<br>
<br>
<ul><li>Research</li></ul>
1. Participates in nursing research at a level consistent with educational background and experience.<br>
2. Maintains understanding of current research of others in related clinical areas through review of relevant publications.<br>
3. Participates in grant writing as appropriate.
<br>
<br>
<ul><li>Supervisory Responsibilities</li></ul>
1. May assume responsibility for providing direction to designated personnel.<p></p><div><div><div><div><div><div><div><p><b><br>
Qualifications</b></p></div></div></div></div></div></div></div><p>
QUALIFICATIONS:<br>
Education/Licensure:</p><div><ul><li><p>
1. Completion of Master's, DNP or PhD Degree in Nursing required. Completion of a Master&rsquo;s or post Masters&rsquo; degree in adult or family NP program accredited by the Commission on Collegiate Nursing Educatin (CCNE) or the National League for Nursing Accrediting Commission (NLNAC) required.</p></li><li><p>
2. Current Acute Care or Adult/Geriatric or Family Nurse Practitioner Certification by an accredited APRN certifying body required.</p></li><li><p>
3. Valid prescriptive authority from both MA DPH and Federal DEA required.</p></li><li><p>
4. Current APRN license to practice in Massachusetts required.</p></li></ul><p></p><p>
Experience:</p><ul><li><p>
1. At least three years clinical Nurse Practitioner experience in oncology required.</p></li><li><p>
2. Demonstrated experience as a responding clinician/APRN to acute adverse reactions required.
</p></li><li><p>3. Prior nursing experience in oncology infusion or medical infusion preferred.</p></li></ul><p></p><p>
Other:</p><ul><li><p>
ANA or other appropriate nursing certification in the area of practice and authorization by the Massachusetts Board of Registration in Nursing to practice in an expanded role. DEA for prescription writing.</p></li></ul><p><br>
SKILL/ABILITIES/COMPETENCIES REQUIRED:</p><ul><li><p>
Expert Clinical judgement skills to function in the independent role.</p></li><li><p>
Excellent interpersonal relationship and communication skills in order to collaborate with patients&rsquo; families, staff and community health workers.</p></li><li><p>
Ability to work with frequent stress resulting from busy clinical settings and changing organizational climate.</p></li><li><p>
Ability to self-directive and demonstrate initiative in addressing responsibilities of position.</p></li><li><p>
Ability to utilize appropriate problem solving and conflict resolution skills.</p></li></ul><p></p><p>
CLINICAL STANDARDS THAT SERVE AS GUIDELINES FOR THIS PRACTICE Nurse practitioner practice conforms to generally accepted standards of care as promulgated by the American Nurses Association and other relevant professional organizations. Patient care management is based on current evidence and sound clinical judgment. Clinical references may include but are limited to: Harrison&rsquo;s Principles of Internal Medicine; Physician&rsquo;s Desk Reference; Barker, Principles of Ambulatory Medicine</p></div><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>
Onsite<p></p><div><div><div><div><div><div><div><p><b><br>
Work Location</b></p></div></div></div></div></div></div></div>
60 Fenwood Road<p></p><div><div><div><div><div><div><div><p><b><br>
Scheduled Weekly Hours</b></p></div></div></div></div></div></div></div>
30<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>
Rotating (United States of America)<p></p><p><b><br>
Pay Range</b></p>
$50.70 - $134.78/Hourly<p></p><p><b><br>
Grade</b></p>
MNA2221Z<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>
2200 The Brigham and Women's Hospital, Inc. 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>

Nurse Practitioner, Oncology Infusion, 30 Hours BWH

<div><div><div><div>Job Ref:</div><div>
JR-3406</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 Gastrointestinal (GI) Oncology Clinical Research Program at Dana-Farber Cancer Institute is seeking a Clinical Research Coordinator (CRC) to join our program. The GI Oncology Clinical Research Program supports PI initiated, industry sponsored, and cooperative group phase I - IV clinical trials across multiple GI cancers, including esophageal, stomach, liver, pancreas, colon, and neuroendocrine.<br>
<br>
The Clinical Research Coordinator 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. 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 - GI Oncology

Boston Children's Hospital

<div><div><div><div>84627BR</div>
</div><div><div>Pediatrics-Allergy and Immunology
</div></div><div><p><b>Job Posting Description</b></p>
<div><b>Position Summary/ Department Summary:</b><br>
<br>
Dr. Rima Rachid, Associate Professor of Pediatrics at Harvard Medical School and Director of the Food Allergy Program at Boston Children&rsquo;s Hospital is seeking a new Clinical Research Study Assistant (CRA) for her investigative work in the Division of Allergy &amp; Immunology. The CRA will coordinate multiple food allergy research studies, including but not limited to randomized controlled interventional trials on biologics and fecal microbiota transplantation in food allergy, a food allergy biorepository, studies on novel biomarkers in food allergy. The applicant should be communicative, highly efficient and well-organized with excellent attention to detail and ability to work independently and harmoniously with the research team.<br>
<br>
<b>Key Responsibilities:</b><ul><li>
Screening, recruiting, and consenting study subjects</li><li>
Acting as a liaison between the research team and study subjects and families to ensure continued information exchange, safety, and support.</li><li>
Managing study-related communication between multiple parties, including the Principal Investigator, nursing staff, research pharmacy, federal and corporate sponsor</li><li>
Study documentation, data management and coordinating the scheduling of patient visits.</li><li>
Document preparation and review for the Institutional Review Board (IRB)</li><li>
Processing and storing blood and stool samples in the laboratory</li><li>
Other investigative and administrative duties, as necessary</li></ul><br>
<b>
Minimum Qualifications</b><br>
<b>Education:</b><ul><li>
Bachelor Degree in STEM or Pyschology is required.</li></ul><br>
<b>
Experience:</b><ul><li>
No experience in clinical research necessary</li></ul></div>
</div><div><p><b>Status</b></p>
<div>Full-Time</div>
</div><div><p><b>Regular, Temporary, Per Diem</b></p>
<div>Regular
</div></div><div><p><b>Standard Hours per Week</b></p>
<div>40
</div></div><div><p><b>Pay Range</b></p>
<div>$41246.40-$61339.20 Annual</div>
</div><div><p><b>Office/Site Location</b></p>
<div>Boston</div>
</div><div><p><b>Job Posting Category</b></p>
<div>Research</div>
</div><div><p><b>Remote Eligibility
</b></p><div>Part Remote/Hybrid</div></div></div></div><div></div>

Clinical Research Assistant-Rachid Lab

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