clinical research coordinator i

clinical research assistant - ibd center Jobs in Boston

clinical research assistant - ibd center

clinical research assistant-rachid lab Jobs in Boston

clinical research assistant-rachid lab

clinical research coordinator ii Jobs in Boston

clinical research coordinator ii

associate director, clinical research program - breast oncology Jobs in Boston

clinical research nurse

Fenway Health

<div>Description:
<p><b>
TFI Department:</b> Biomedical Research</p><p><b>
Work Location</b>: In-person</p><p><b>
Schedule:</b> Monday-Friday, first shift. This position may require a flexible working schedule with some evening and weekend hours.</p><p>
This position sits within The Fenway Institute (TFI), the research, education, and policy department of Fenway Health. Reporting to the Associate Medical Director and under the supervision of the Principal Investigator and other TFI Leadership, the Clinical Research Nurse (RN) supports the implementation of research studies in the Biomedical Research department.</p><p><b>
Position Funding</b></p><p>
This position is grant-funded and is dependent on the availability of continued grant support for the assigned study/studies. It is possible that the employee&rsquo;s effort will be transitioned, in whole or in part, to other research studies as needed.</p><p><b>
Representative Duties</b></p><p><b>
Provides Clinical Care for Research Protocols</b></p><ul><li>
Monitor study participants&rsquo; health before, during, and after research study visits.</li><li>
Assist study providers with adverse event monitoring and reporting</li><li>
Perform clinical procedures, in collaboration with study providers, that includes but is not limited to: obtaining vital signs, administering injections, performing symptom-directed physical exams, collecting detailed health histories, conducting sexual health risk-reduction counseling, performing electrocardiograms, and sample collection (i.e., venous blood; oral, anal, and genital cultures; and urine/stool/tissue specimens)</li><li>
Start and maintain peripheral intravenous lines</li><li>
Assist providers in assessing, interpreting, and communicating laboratory results to the participant</li><li>
Translate clinical information for non-clinical research staff (e.g., study coordinators and research associates)</li><li>
Maintain the emergency crash cart on the research floor</li></ul><p><b>
Assist the Non-Clinical Team with Participant Interaction and Data Collection</b></p><ul><li>
Obtain informed consent: Explain study procedures and risks/benefits to participants.</li><li>
Conduct study visits: Carry out research visits according to specific instructions. Schedule study visits and maintain study calendar/visit spreadsheets. Confirm participant eligibility and assist with or perform tasks like administering surveys, collecting biological samples (e.g., blood, urine), taking vitals, and scheduling follow-ups. Accurately and comprehensively complete visit notes, data collection instruments, case report forms, etc.</li><li>
Monitor participant safety: Report non-compliance, adverse events, or unanticipated problems promptly to the research leads.</li></ul><p><b>
Data Management and Documentation</b></p><ul><li>
Maintain accurate records: Ensure timely and accurate entry of data into study files, including paper files and electronic databases (e.g., REDCap, EDC systems), and keep organized and complete source document files, including signed consent forms, case report forms, and lab reports.</li><li>
Assist in data cleaning and audit preparation: Monitor the quality of collected data through routine and ad hoc quality assurance and quality improvement activities (e.g., record review, monitor visit preparation, completion of visit checklists) and respond to data queries.</li><li>
Use best research practices, as defined by Good Clinical Practice (GCP), TFI standard operating procedures, study specific procedures, and the research protocol and follow all established guidelines of confidentiality and ethical accountability.</li></ul><p><b>
Communication and Collaboration</b></p><ul><li>
Liaise with internal and external teams: Communicate with investigators, sponsors, IRBs, and study monitors. Share study information to Fenway Health staff, patients, and community.</li><li>
Attend team and departmental meetings: Provide updates and help resolve logistical or compliance issues.</li><li>
Support training and onboarding: Help train research staff on vital signs, phlebotomy, and other clinical support tasks</li></ul><p><b>
Administrative and Logistical Support</b></p><ul><li>
Coordinate Clinic-based Studies: Depending on interest, assist or lead the coordination of research protocols, especially those that require integration with the Fenway Health clinic team.</li><li>
Manage supplies and equipment: Track, maintain, and order study-specific materials.</li><li>
Develop and share understanding of research context: Monitor and track institutional, state level and federal level policies impacting participant population and research; develop knowledge of field by completing pertinent trainings, attending didactics, reading academic journals, articles and other relevant publications, attending conferences, seminars, forums, trainings and other presentations.</li></ul><p><b>
Meets Agency Participatory Expectations</b></p><ul><li>
Adheres to all agency and departmental policies and procedures</li><li>
Identifies potential or actual unsafe situations in the environment and takes measures to rectify the situation</li><li>
Attends all required meetings, in-services and professional trainings</li><li>
Maintains professional competence necessary to perform job responsibilities; maintains and provides agency with records of continuing education activities</li><li>
Serves on agency committees and in professional organizations when requested</li><li>
Work harmoniously and effectively with colleagues, patients, clients and vendors across the spectrum of diversity, including but not limited to race, ethnicity, color, gender identity, sexual orientation, age, socio-economic status, national origin and immigrant status, religious or spiritual identity, disability (physical, mental, emotional and developmental), veteran status, and/or limited English proficiency.</li></ul>
Requirements:
<ul><li>Current licensure as a Registered Nurse in the Commonwealth of Massachusetts</li><li>
Current BLS certification</li><li>
Bachelor&rsquo;s degree in a health-related field</li><li>
Demonstrated ability to work respectfully and effectively with individuals from a wide range of backgrounds, perspectives, and life experiences. This includes engaging constructively with colleagues, patients, clients, and vendors in a manner that reflects professionalism, empathy, and cultural awareness, without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, or other protected characteristics as defined by applicable law.</li></ul><p><b>
Preferred Qualifications</b></p><ul><li>
Bachelor of Science in Nursing preferred</li><li>
1-2 years in a clinical setting</li><li>
Phlebotomy and IV placement experience</li><li>
Excellent health history and physical assessment skills</li><li>
Working knowledge of HIV and STI pathophysiology, prevention, and treatment</li><li>
Experience and comfort working with gender, racial, and sexual diverse populations as well as with people who use substances, including people living with HIV</li></ul><p><b>
Position Restrictions</b></p><p>
Due to the nature of TFI research, anyone currently participating in a TFI intervention/interaction study cannot work within the research department, or for one year after the study has concluded.</p><p><b>
Physical Requirements:</b></p><ul><li>
Requires being able to work a 7.5 hour day, the majority of it sitting (&gt;70%)</li><li>
Requires handling average-weight objects up to 15-20 pounds, assisting with patients&rsquo; standing and/or walking when necessary</li><li>
May work with blood or blood-borne pathogens</li><li>
Work environment involves exposure to potentially dangerous materials and situations that require following extensive safety precautions and may include the use of protective equipment</li></ul>
We offer competitive salaries, and for those who qualify, an excellent benefits package; including comprehensive medical and dental insurance plans, and a retirement plan with employer match. We also provide 12 paid holidays, paid vacation, and more.<b>LGBTQIA+ identified persons, Black, Indigenous, and other people of color (BIPOC), and individuals from other historically underrepresented communities are strongly encouraged to apply.</b><i>This is a union position in a Fenway Health bargaining unit represented by 1199 SEIU United Healthcare Workers East.</i></div>

Clinical Research Nurse

Tufts University

<div>Overview:
<div>The USDA-Human Nutrition Research on Aging (HNRCA) is one of six USDA human research centers created to study the effect of human nutrition on health. The HNRCA mission is to conduct state-of-the-art research on human nutrition and aging.<br>
<br>
The Metabolic Research Unit (MRU) is comprised of Volunteer Services, Nursing Services, and Dietary Services. The MRU&rsquo;s Volunteer Services Division maintains a database from which they can recruit. In addition, potential study participants are recruited for a variety of population, longitudinal, metabolic, and free-living nutrition studies through use of social media, advertisements, and mailing lists. Research nurses and support staff implement research protocols and continually assess and monitor free-living study participants. Registered dietitians and dietary support staff develop and implement the dietary component of research protocols, which includes strict feeding protocols created in the MRU research kitchen with careful food intake monitoring throughout the duration of each study. All human research studies carried out in the MRU are reviewed and approved by the Tufts Medical Center and Tufts University Health Sciences Institutional Review Board (IRB).</div>
What You'll Do:
<div><b>This is a part-time position at 21 hours per week. This is also a grant-funded position and is not eligible for severance pay.</b></div><div>
</div><div>
The Clinical Research Nurse is a registered professional nurse, who manages the clinical course of research volunteers throughout a study. The primary function of the Clinical Research Nurse is to conduct human research protocols, in a carefully monitored, controlled, yet dynamic environment to achieve quality outcomes for data and volunteer safety to support the HNRCA research goals. The Clinical Research Nurse is responsible for knowledge of Federal Regulations (45CFR46) and the FDA Regulations (21CFR50, 56), policies and procedures of the TMC-IRB, and all other guidance documents for the conduct of human clinical trials and human subject protection. The Clinical Research Nurse utilizes the nursing process-assessment, planning, implementation, evaluation and documentation to attain volunteer safety and data integrity.</div><p></p><div><br>
<ul><li>
Protocol Execution/data collection:<ul><li>
Responsible for assessing prospective volunteers for study eligibility and conducting review of subject health history for multiple studies. Responsible for reviewing HNRCA/Tufts and USDA, building regulations and federal regulations governing conduct on federal property.</li><li>
Admits study subjects and obtains informed consents.</li><li>
Executes intra-study informed consents for multiple studies. Assesses changes in health and eligibility status throughout conduct of studies. Recognizes, documents and reports medical issues, abnormal laboratory values to study MD and tracks follow-up. Notifies PI/MD of adverse events.</li><li>
Administers investigational substances according to protocol and regulatory requirements. Uses the following nursing skills for data collection: phlebotomy, IV (insertion and maintenance), volumetric infusion pump use, gastric tube placement and sampling, resting metabolic rates, EKG, assists with protocol procedures e.g. fat biopsy, muscle biopsy, etc.</li><li>
Assesses protocol tolerance and compliance.</li><li>
Collects and documents participant health and research data.</li><li>
Assesses subject future study eligibility status.</li><li>
Delivers professional nursing care.</li><li>
Conducts self in a competent and compassionate manner.</li><li>
Sets priorities in consultation with supervisor using time and resources effectively.</li><li>
Maintains and provides documentation (written and electronic) in the research record. Follows HNRCA best practices for data collection, data retention and data QC procedures.</li><li>
Informs PI/MD of pertinent clinical issues and adverse events.</li><li>
Initiates medical emergency system as needed.</li>
May need to provide evening, weekend, and/or overnight coverage as indicated by protocol and unit needs.<br>
<li>
</li></ul></li><li>
Protocol Development:<ul><li>
Implements regulatory requirements of the TMC Investigational Review Board for Human Studies and Good Clinical Practice.</li><li>
Perform risk management assessment of protocol requirements to insure volunteer safety.</li><li>
Implements, coordinates and monitors the safe and accurate collection of protocol- specific clinical data on the MRU and occasionally offsite.</li><li>
Maintains a thorough knowledge of MRU protocols.</li><li>
Confirms IRB approval of research protocols with principal investigators prior to study initiation; tracks modifications of protocols and subsequent IRB approvals, and communicates modifications of protocols to the nursing staff.</li><li>
Interprets and communicates research protocol requirements and takes steps to clarify and/ or resolve issues pertaining to protocol execution.</li><li>
Oversees the administration of informed consent to human subjects in accordance with procedure approved by the Tufts University Medical Center IRB.</li><li>
Develops, revises/updates data collection procedures based on regulations and guidance documents; determines and secures equipment and supplies (to include pharmaceuticals).</li><li>
Documents and maintains all assigned study-related procedures, processes and events.</li><li>
As protocol nurse, participates in protocol meetings and ongoing collaboration with the study team. Plans and designs all study- specific forms and documents. Plans nursing staff study orientation and serves as a resource person for staff for assigned protocols.</li></ul></li><li><ul><li>
Maintains skills in CPR, AED and Human Protection Certification.</li><li>
Also is knowledgeable of the HNRCA fire and safety procedures, biohazard and radiation safety requirements.</li><li>
Participates in professional development.</li></ul></li></ul></div>
What We're Looking For:
<div><b>Basic Requirements:</b><br>
<i>Knowledge and experience typically acquired by:</i><ul><li>
Graduate of an accredited nursing program.</li><li>
Three to five years of acute clinical experience</li><li>
Proficient with Microsoft Office software suite, email, web search.</li><li>
Must be willing to attend external IV training within the first year of employment</li><li>
Ability to complete CITI and NIH GCP training in the protection of human research subjects (required prior to interacting with human subjects), CPR and AED certification within 2 weeks of hire.</li><li>
Ability to lift 25lbs with or without accommodations.</li><li>
Ability to maintain professional and technical knowledge.</li><li>
Must be a licensed Massachusetts Registered Nurse and maintain current licensure to practice.</li></ul></div><div>
</div><div><b>
Preferred Qualifications:</b><ul><li>
Experience in clinical research</li><li>
IV and phlebotomy skills and experience</li><li>
Ability to learn and utilize new software and database programs, including REDCap for electronic data capture</li><li>
Demonstrated ability to work with a diverse multicultural group of study subjects and colleagues</li><li>
Ability to work effectively in a team environment</li></ul></div>
Salary Range: Minimum $79,600.00, Midpoint $99,600.00, Maximum $119,500.00</div>

Clinical Research Nurse - Human Nutrition Research Center on Aging

Whittier Street Health Center

<p><b>Compensation &amp; Benefits Include:</b></p><ul><li>$42.00&ndash;$48.00 hourly</li><li>Health, dental, and vision insurance</li><li>Employer-funded pension &amp; life insurance</li><li>403(b) retirement plan</li><li>Paid time off and holidays</li><li>CME reimbursement and licensure support</li></ul><p><b>The Opportunity:</b></p><p>Whittier Street Health Center is seeking a full-time Clinical Programs Nurse to join our Center for Health Equity Research. In this role, you will support the coordination and delivery of clinical programs, working closely with care teams and patients to manage chronic conditions, support preventive initiatives, and contribute to research-related activities.</p><p>The Center for Health Equity Research advances equitable health outcomes through community-centered care and clinical research. By integrating preventive care, specialty clinics, and evidence-based interventions, the Center works to address chronic disease disparities, improve access, and enhance long-term outcomes for the communities we serve.</p><p><b>Key Responsibilities:</b></p><ul><li>Coordinate clinical program activities including Remote Patient Monitoring, specialty clinics, and prevention initiatives</li><li>Identify and engage eligible patients through outreach, referrals, and registry review</li><li>Provide patient education on chronic disease management, screening, and follow-up care</li><li>Support clinical research activities including recruitment, enrollment, and data collection</li><li>Ensure compliance with IRB protocols, regulatory standards, and Good Clinical Practice (GCP)</li><li>Coordinate referrals and support navigation to specialty and supportive services</li><li>Document patient interactions and maintain accurate clinical and research data</li><li>Collaborate with care teams to improve workflows, program outcomes, and quality initiatives</li></ul><p><b>Qualifications:</b></p><ul><li>Licensed Registered Nurse in the Commonwealth of Massachusetts</li><li>3&ndash;5 years of RN experience, preferably in primary care, population health, or research settings</li><li>Experience with phlebotomy required</li><li>Experience with EMR systems required; EPIC strongly preferred</li><li>Proficiency in Microsoft Office and standard computer applications</li><li>Strong communication, organizational, and time-management skills</li><li>Ability to work effectively in multidisciplinary and multicultural environments</li><li>Current Basic Life Support (BLS) certification</li></ul><p><b>Join Our Team!</b></p><p>Whittier Street Health Center is dedicated to advancing health equity and delivering high-quality, culturally responsive care. We are committed to building a diverse, inclusive workplace where every team member contributes to improving the health and well-being of our community. If you&rsquo;re ready to make a meaningful impact, we&rsquo;d love to hear from you.</p><p>#indlp</p><p>Pay: $42.00 - $48.00 per hour</p><p>Benefits:</p><ul><li>403(b)</li><li>Continuing education credits</li><li>Dental insurance</li><li>Disability insurance</li><li>Employee assistance program</li><li>Flexible spending account</li><li>Health insurance</li><li>Health savings account</li><li>Life insurance</li><li>Paid time off</li><li>Referral program</li><li>Retirement plan</li><li>Tuition reimbursement</li><li>Vision insurance</li></ul><p>Application Question(s):</p><ul><li>How many years of experience do you have working as a Registered Nurse?</li><li>Are you currently licensed as a Registered Nurse in Massachusetts?</li><li>Do you have experience performing phlebotomy?</li></ul><p>Ability to Commute:</p><ul><li>Boston, MA 02120 (Required)</li></ul><p>Work Location: In person</p>

Clinical Programs Nurse | Center for Health Equity Research | Boston

Dana-Farber Cancer Institute

<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-3474</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 Head &amp; Neck 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 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.<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>
Oversight of the clinical trials start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities.</p></li><li><p>
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.</p></li><li><p>
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.</p></li><li><p>
Ensure all study related samples are collected, properly prepared, and shipped according to the protocol requirements and IATA/DOT regulations.</p></li><li><p>
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.</p></li><li><p>
Responsible for organizing and preparing for both internal and external auditing and study monitoring visits.</p></li><li><p>
Coordination and management of clinical trials throughout the trial life cycle, including communication with sponsors and regulatory authorities.</p></li><li><p>
Close-out of clinical trials, including contributing to research articles, audit preparation, and communication with regulatory agencies and other disciplines involved.</p></li><li><p>
Interact with study participants as directed/required by the protocol and/or study team.</p></li><li><p>
May be responsible for tissue sample collection per trial requirements.</p></li><li><p>
Responsible for data entry of Subject Visit Tracking information into Clinical Trial Management System contemporaneously with medical visits, assessments, and other subject-specific information.</p></li><li><p>
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.</p></li><li><p>
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.</p></li></ul><p><b>
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:</b></p><ul><li><p>
Excellent organization and communications skills required.</p></li><li><p>
Strong interpersonal skills &ndash; ability to effectively interact with all levels of staff and externals contacts.</p></li><li><p>
Must be detail oriented and have the ability to follow-through.</p></li><li><p>
Ability to effectively manage time and prioritize workload.
</p></li><li><p>Must practice discretion and adhere to hospital confidentiality guidelines at all times.</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 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.
</p></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 - Center for Head and Neck 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>
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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

Tufts Medical Center

<div><div><p><b>Job Overview:</b></p><p>
This position will assist the Principal Investigators (PIs) and Cardiovascular Director of Clinical Research in planning and implementing clinical research studies as assigned.</p><p></p><p><b>
Job Profile</b><b> Summary</b></p></div><div><p>
This role focuses on performing work related to research and development of new products, innovation, and improvement of products and processes. In addition, this role focuses on performing the following Research Programs and Projects duties: Supports the development of new products and innovation. Includes Clinical roles focused on research projects. Positions in this family perform basic, translational, and/or clinical research towards solving a specific problem for an entity or community. A professional individual contributor role that may direct the work of other lower level professionals or manage processes and programs. The majority of time is spent overseeing the design, implementation or delivery of processes, programs and policies using specialized knowledge and skills typically acquired through advanced education. An entry level role that applies broad theoretical job knowledge typically obtained through advanced education. May require the following proficiency: work is closely supervised, problems faced are not typically difficult or complex, and explains facts, policies and practices related to job area.</p></div><p></p><div><p><b><br>
Job Description</b></p></div><div><p><b>
Minimum Qualifications:</b></p></div><div><p>
1. Bachelor&rsquo;s degree OR High School Diploma or equivalent <b>AND</b> Four (4) years of related experience.</p></div><div><p>
2. Basic Life Support (BLS) certification may be required based on specific role requirements.</p><p>
3. Two (2) years in research related activities.</p></div><p></p><div><p><b><br>
Preferred Qualifications:</b></p></div><div><p>
1. Five (5) years in research related activities.</p></div><div><p>
2. Previous experience in clinical trials.</p><div><p>
3. IATA Hazardous Good Shipping certification.</p></div><div><p>
4. CITI Human Research Protection certification.</p></div></div><p></p><div><p><b><br>
Duties and Responsibilities</b><b>:</b> The duties and responsibilities listed below are intended to describe the general nature of work and are not intended to be an all-inclusive list. Other duties and responsibilities may be assigned.</p></div><p></p><div><p><br>
1. Responsible for assisting in the recruitment of study participants.</p></div><div><p>
2. Organizes strategies for recruiting study participants, and screening study participants for eligibility on the telephone, in the clinic and other settings as required.</p></div><div><p>
3. Completes follow up with study participants in prescribed settings as required.</p></div><div><p>
4. Completes record abstraction of source documents, conducting required study measurements and completing study Case Report Forms in accordance with best practice methods.</p></div><div><p>
5. Complies with all institutional policies and government regulations pertaining to human subjects&rsquo; protections.</p></div><div><p>
6. Responsible for assisting with Institutional Review Board (IRB) requirements for each study including meeting institutional educational requirements, submitting documents for review, adverse event reporting and annual reviews.</p></div><div><p>
7. Performs basic laboratory activities as needed.</p></div><div><p>
8. Maintains patient confidentiality per HIPAA regulations and keeps study information in a safe and secure location. Adheres to FDA Good Clinical Practice Guidelines.</p></div><div><p>
9. Identifies and resolves problems with protocol compliance by notifying investigator and as necessary with the protocol sponsor.</p></div><div><p>
10. Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator.</p></div><div><p>
11. Performs necessary tests as needed and as appropriate to level of training such as EKGs, Walk tests, etc.</p></div><div><p>
12. Organizes and participates in site visits with the study sponsor to review completeness and accuracy of study documentation.</p></div><div><p>
13. Maintains inventory of all study supplies.</p></div><div><p>
14. Assesses potential patients and eligibility for inclusion in a particular protocol based on protocol requirements.</p></div><div><p>
15. Reviews all eligibility and ineligibility criteria in the patient&rsquo;s record.</p></div><div><p>
16. Verifies information with the physician. Interviews patients to obtain information for eligibility assessment, explain the study, and obtains signature for the informed consent form.</p></div><div><p>
17. Conducts a QC check of completed CRFs prior to submission for data entry.</p></div><div><p>
18. Coordinates resolution of all data queries.</p></div><div><p>
19. Completes data entry as warranted.</p></div><div><p>
20. Maintains regulatory binders, case report forms, source documents, and other study documents.</p></div><div><p>
21. Monitors the occurrence of clinical adverse events, reporting any to the (PI), the study sponsor and Institutional Review Board.</p></div><p></p><div><p><b><br>
Physical Requirements:</b></p></div><div><p>
1. Typical clinical and administrative office setting.</p></div><p></p><div><p><b><br>
Skills &amp; Abilities:</b></p></div><div><p>
1. High degree of organizational talents, data collection and analysis skills.</p></div><div><p>
2. Requires meticulous attention to detail.</p></div><div><p>
3. Excellent computer skills including word processing.</p></div><div><p>
4. Ability to prioritize quickly and appropriately.</p></div><div><p>
5. Excellent communication and interpersonal skills.</p></div><div><p>
6. Systematic record-keeping.</p></div><p></p><p><br>
At Tufts Medicine, we want every individual to feel valued for the skills and experience they bring. Our compensation philosophy is designed to offer fair, competitive pay that attracts, retains, and motivates highly talented individuals, while rewarding the important work you do every day.</p><p></p><p>
The base pay ranges reflect the minimum qualifications for the role. Individual offers are determined using a comprehensive approach that considers relevant experience, certifications, education, skills, and internal equity to ensure compensation is fair, consistent, and aligned with our business goals.</p><p></p><p>
Beyond base pay, Tufts Medicine provides a comprehensive Total Rewards package that supports your health, financial security, and career growth&mdash;one of the many ways we invest in you so you can thrive both at work and outside of it.</p><p></p><p><b><br>
Pay Range</b><b>:</b></p><br>
<p></p>
$47,924.24 - $59,894.75</div>

Clinical Research Coordinator II - CardioVascular

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