Promote good clinical practices in the conduct of clinical investigations by possessing an in-depth knowledge of federal regulations and K2 Medical Research guidelines (SOPs) for the enrollment and maintenance of subjects in clinical trials, and by collecting, recording, and maintaining source and sponsor documentation. Job DescriptionJob Description
At K2 Medical Research, we are transforming healthcare by delivering tomorrow’s treatments today.
p>The clinical practice includes excellence in a number of key areas including an amyloidosis and myeloma program, an autologous and allogeneic bone marrow transplant program, active CAR-T trials and protocols for malignant and non – malignant conditions, an Adolescent and Young Adult Survivor Program, and patient navigation specifically to address the needs of the Boston Chinatown and Asian language communities. The Division Chief will provide strategic leadership across all missions—clinical care, research, and education—with a particular emphasis on:
This is an opportunity to provide clinical leadership in developing RNAi therapeutics in client's rapidly expanding portfolio, which spans the areas of rare genetic diseases, cardio-metabolic diseases, neuroscience, hematology and hepatology. The Senior Director, Clinical Research, will work in a matrix organization across Regulatory, Biostatistics, Clinical Operations, Preclinical, Commercial & QA teams to ensure fully harmonized and integrated development strategies.
This is an opportunity to provide clinical leadership in developing RNAi therapeutics, rapidly expanding portfolio, which spans the areas of rare genetic diseases, cardio-metabolic diseases, neuroscience, hematology and hepatology. While the primary focus responsibility will be as clinical lead physician on client's autoimmune liver disease programs, the role may support across a range of therapeutic areas and all stages of development may be required as pipeline assets evolve.
Marlborough, MA2 days ago
strong> Qualifications • B.S. or B.A. in Chemistry, preferably from an Client (American Chemical Society) accredited program • A thorough understanding of chemistry at the undergraduate level • Experience with general laboratory techniques such as distillation, filtration, closed transfer, crystallization, rotary evaporators, vacuum pumps/ovens and small/large scale glassware. • Assisting more senior chemists with their work • Perform analysis of compounds and reaction mixtures using common methods: (HPLC, GC, MS, UV/VIS, FTIR, NMR, TLC, IR, GCMS) • Involvement in process improvement and development of production and test methods • Versatility in common IT applications (Microsoft office).
li>Working closely with clinical and operational leaders across Tufts Medicine, the CVSL PE will ensure Tufts Medicine is staying at the forefront of alternative payment models and maintaining value added relationships with industry and payor partners, and in doing so, leading the service line in the development of strategies that focus on continuous quality improvement, efficient clinical delivery, and maximizing patient value. Our cardiovascular clinical and translational research mission is within in the CardioVascular Center for Research & Innovation (CVCRI), dedicated to fostering new approaches to clinical research, innovation, education and patient outcomes through an integrated cardiovascular research pipeline.
li>Received training or demonstrated ability to perform/understand relevant tools such as cause and effect diagram, driver diagram, failure modes and effects analyses, run chart & control chart, Pareto chart, PDSA worksheet, etc. With anticipated growth of academic radiology at Tufts Medical Center and system-wide radiology within the Tufts Medicine System, there will be an expansion of services and imaging volumes in the near future, allowing the VCQ to craft the Departments clinical service to be a regional, national and international leader.
p>With anticipated growth of academic radiology at Tufts Medical Center and system-wide radiology within the Tufts Medicine System, there will be an expansion of services and imaging volumes in the near future, allowing the VCO to craft the Department’s clinical service to be a regional, national and international leader. VCO will report to the Chair, and work collaboratively with Vice Chair of Quality, Section Chiefs of the Department, Executive Director, Director of Clinical Administration, Chief of Technologists, and the Radiology Residency/Fellowship leadership team.
p>VABHS maintains state-of-the-art radiology equipment across multiple campuses, including three 3T MRI units (one of which is dedicated to research), 3 additional 1.5T MRI units, and 5 CT units. Qualified individuals should also process experience in managing budgets and financial plans for the department and experience with the day-to-day operations of a radiology department, including workflow efficiency and staff supervision.
li>Assist with the design, development, and delivery of comprehensive training programs using evidence-based instructional design principles (e.g., ADDIE, backwards design, adult learning theory) for research administration staff at all levels. - Develop and deliver specialized training on the full lifecycle of sponsored research (pre-award, post-award, compliance, closeout) and translate complex federal regulations and University policies into accessible training content for central and departmental staff and faculty.
Reporting to the Director of Administration and Finance, the Assistant Director provides essential support to faculty and plays a key role in ensuring efficient and compliant research administration; leads talent management succession planning efforts while overseeing all sponsored research-related research administration functions; develops and implements financial models and strategies to enhance the efficiency of research and financial operations; serves as a trusted advisor to faculty and departmental leadership on financial and administrative aspects of sponsored research; creates and delivers clear, effective trainings and presentations; supervises and mentors research administration staff, and performs high-level financial work, including budget oversight, planning, and management; and acts as the primary liaison to MIT's central finance offices on research administration matters. ASSISTANT DIRECTOR OF RESEARCH ADMINISTRATION, Chemical Engineering, leads and oversees complex pre- and post-award financial operations and manages a team of 8-10 staff responsible for the department's full research administration portfolio at MIT.
p>Summary: Provides assistance to the Principal Investigator and Study Team in coordinating research activities that may include conducting a variety of routine experiments with established methodologies, data collection and management, and other research activities as assigned.
Site: The Brigham and Women''s Hospital, Inc.
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.
The role involves assisting with the preparation of scientific manuscripts and PowerPoint presentations, proofreading grant submissions, helping to manage the Centers grant portfolio, and general office tasks (e.g., ordering supplies, processing reimbursement, hiring, scheduling and coordinating meetings, travel arrangements, preparing expense reports, updating website). The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, training and internal pay comparison.
The Neurofibromatosis Research Initiative (NFRI) within the Division of Genetics and Genomics at Boston Children's Hospital is seeking a Clinical Research Assistant to facilitate recruitment of participants in clinical research studies related to Neurofibromatosis Type 1 (NF1). Third, we are recruiting participants with NF1 who are at higher risk of NF1-related tumors to prospectively collect blood samples that will be analyzed for early markers of tumor development (a so-called "liquid biopsy").
Boston, Massachusetts17 days ago
Summary: Provides assistance to the Principal Investigator and Study Team in coordinating research activities that may include conducting a variety of routine experiments with established methodologies, data collection and management, and other research activities as assigned. At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level.
The role involves assisting with the preparation of scientific manuscripts and PowerPoint presentations, proofreading grant submissions, helping to manage the Centers grant portfolio, and general office tasks (e.g., ordering supplies, processing reimbursement, hiring, scheduling and coordinating meetings, travel arrangements, preparing expense reports, updating website). The Center for Behavioral Science Research is hiring an research administrative assistant to support the functions of the center and its Director.
Communicating schedule of study events with research families and serve as liaison to the families/patients in the research studies, conducted at both on-site and off-site locations, guiding and advising them throughout each phase of the study. This is an exciting opportunity to work within a multidisciplinary team furthering research and bringing new treatments to rare genetic conditions and is an ideal position for someone who desires to be at the intersection of cutting-edge research and patient care.
This Clinical Research Assistant will join an established team of clinicians and researchers in Ophthalmology dedicated to understanding blinding pediatric retinal diseases and identifying those patients who may be eligible for treatment trials. Coordinates and prepares the necessary documentation for Institutional Review Board IRB and Committee on Clinical Investigations CCI submissions, in collaboration with other team members and Principal Investigator.
Research activities may involve but are not limited to regulatory submissions, data abstraction from the medical record, data and specimen coordination, study preparation, and patient screening and patient contacts both in person and by phone. The CRA in this position will interact with a variety of investigators from the Benderson Family Heart Center (Cardiology, Cardiac Surgery and Cardiovascular Nursing), and the inpatient/outpatient Cardiology Clinic.
Conducts patient recruitment, administers questionnaires, abstracts medical records, maintains patient databases, performs administrative tasks, assists in grant preparation, performs literature searches and participates with the research team in preparation of data and other reports. Recruits subjects to participate in the study by using approved methodologies, such as, reaching to healthcare providers for referrals, visiting clinics, sending mailouts, using approved advertisements, etc.
p>Position Summary: The Rosamund Stone Zander and Hansjoerg Wyss Translational Neuroscience Center (TNC) is comprised of translational investigators and clinical experts focused on neurogenetic and neurodevelopmental disorders.
Work requires well-developed communication skills in order to provide critical information to patients, effectively deal with conflicting views or issues, and the ability to mediate fair solutions.
The responsibilities of the Clinical Research Assistant (CRA) will include data collection among participants with diverse neurodevelopmental conditions, EEG and related equipment set-up and maintenance, study protocol development, data uploading and organization, and other relevant data collection tasks. Serves as liaison to the families/patients in the research studies, conducted at both on-site and off-site locations, guiding and advising them during data collection.
p>Position Summary: The Rosamund Stone Zander Hansjoerg Wyss Translational Neuroscience Center (TNC) is comprised of translational investigators and clinical experts focused on neurodevelopmental disorders. The clinical research assistant works with TNC genetic counselors, research fellows, and physicians to execute a multitude of activities related to natural history studies and translational research.
Position Summary: The Center for Advanced Intestinal Rehabilitation and Home Parenteral Nutrition Program is seeking a Clinical Research Assistant to support day-to-day study operations, participant engagement, clinical data collection and management, and collaboration with our interdisciplinary gastroenterology and surgical research teams. This position will also support two additional industry-sponsored clinical trials: A multicenter study evaluating DEFENCATH in reducing central-line associated bloodstream infections (CLABSIs) in adults receiving total parenteral nutrition through a central venous catheter.
Our team works at the intersection of research and patient care, collaborating closely with families and patient advocacy groups to advance personalized medicine. The Yu Lab at Boston Children's Hospital focuses on developing innovative therapies for rare genetic diseases, with a particular emphasis on antisense oligonucleotides (ASOs).
Assist in developing supportive study documents such as informed consent forms, monitoring templates, study subject tracking tools, monitoring forms, study manuals, and training materials, as required for a study. Serves as liaison to the families/patients in the research studies, conducted at both on site and off-site locations, guiding and advising them throughout each phase of the study.
p>The Neurobiology of Fear lab at McLean and Center for Suicide Research and Prevention at MGB/Harvard is seeking applications for 1 full-time Clinical Research Assistant (CRA) to coordinate and administer an NIMH-funded project (led by PIs Dr. Kerry Ressler and Dr. Rebecca Fortgang) aimed at using mobile devices to understand, predict, and intervene to prevent suicidal behavior among adults recently hospitalized on a psychiatric inpatient unit. The Ressler Lab in McLean's Depression & Anxiety Division seeks to advance what is known about the brain, behavior, and symptom mechanisms underlying adult mental health conditions, including suicide, non-suicidal self-injury, depression, PTSD, anxiety, and bipolar disorder.
p>Customer Service: Ability to provide a high level of customer service to patients, visitors, staff and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem solving. Extracts data on protocol subjects from hospital records, outpatient charts and private physician office records in order to complete case report forms required by specific protocols.
Burlington, MA30+ days ago
Actual compensation is determined based on several factors, that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other applicable factors permissible by law. HCM is the most common inherited heart condition with a prevalence of 1:500 globally and remains the most common cause of sudden death in young patients and a major cause of heart failure in patients of all ages.
Conducts patient recruitment, administers questionnaires, abstracts medical records, maintains patient databases, performs administrative tasks, assists in grant preparation, performs literature searches and participates with the research team in preparation of data and other reports. The Research Assistant will assist with data collection by conducting clinical interviews and administering surveys; participant scheduling and correspondence; reviewing recorded clinical interviews; and attending team meetings.
p>The Clinical Research Manager, in collaboration with the program's physicians and research nursing staff, are responsible for the design, implementation and evaluation of their program's clinical research activities (therapeutic and non-therapeutic), all related regulatory and compliance oversight, and direct supervision of their program's clinical research staff. This Clinical Research Manager (CRM) position will work within the Breast Oncology clinical research program and manage the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator and the Clinical Trials Office.
The ideal candidate will have a bachelors degree (Management Information Systems or Computer Science, preferred), will have a strong interest in issues surrounding alcohol and other drug use, and a desire to work with populations impacted by substance use. The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, training and internal pay comparison.
The CRC procures, processes and ships research specimens and conducts patient recruitment, administers questionnaires, abstracts medical records, maintains patient databases, enters data into sponsor-specific electronic data capture forms, performs administrative tasks, assists in grant preparation, and participates with the research team in preparation of data and other reports. Career Advancement/Professional Development: Access a wealth of ongoing training and development opportunities that will not only enhance your skills but also expand your knowledge base especially for individuals pursuing careers in medicine or biomedical research.
Boston, Massachusetts30+ days ago
p style="text-align:inherit"/>Responsible for screening patients for participation in clinical trials, enrolling patients onto these studies, monitoring protocol implementation, completing required forms and reporting results.
Customer Service: Ability to provide a high level of customer service to patients, visitors, staff and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem solving.
SPECIAL WORKING CONDITIONS: May require flexibility to work weekends and evenings JOB BENEFITS: Competitive pay Tuition reimbursement and tuition remission programs Highly subsidized medical, dental, and vision insurance options Career Advancement/Professional Development: Access a wealth of ongoing training and development opportunities that will not only enhance your skills but also expand your knowledge base especially for individuals pursuing careers in medicine or biomedical research. Duties include but are not limited to entering and updating data, maintaining databases, running reports, storing samples, and performing other administrative tasks in support of the clinical studies in addition to potential assisting with patient recruitment, scheduling study visits, administering questionnaires, creating and filing case report forms.
Position Summary: The Surgical Clinical Research Core at Boston Children's Hospital supports the research mission of the Department of Surgery by providing access to a wide range of research tools, collaborating with providers to develop new studies, and coordinating multiple ongoing projects. This position provides hands-on exposure to clinical research and offers opportunities to work closely with investigators, clinicians, and research staff in support of ongoing surgical research projects.
Conducts patient recruitment, consens participants, administers questionnaires, abstracts medical records, maintains patient databases, performs administrative tasks, performs literature searches and participates with the research team in preparation of data and other reports. Career Advancement/Professional Development: Access a wealth of ongoing training and development opportunities that will not only enhance your skills but also expand your knowledge base especially for individuals pursuing careers in medicine or biomedical research.
Conducts patient recruitment, administers questionnaires, abstracts medical records, maintains patient databases, performs administrative tasks, assists in grant preparation, performs literature searches and participates with the research team in preparation of data and other reports. Recruits subjects to participate in the study by using approved methodologies, such as, reaching to healthcare providers for referrals, visiting clinics, sending mailouts, using approved advertisements, etc.
The ideal candidate will have a bachelors degree, and will have a strong interest in issues surrounding alcohol and other drug use, and a desire to work with populations impacted by substance use. The primary responsibility of the Research Assistant is to screen, recruit, enroll and interview research participants for the purpose of collecting study data.
p>Responsibilities include supporting CICU investigators in all of the stages of clinical research: including research initiation, regulatory (IRB) submission, care coordination of subjects, required education of staff, maintenance and adherence to the protocol, monitoring of data, reporting to both sponsor and IRB until close-out of each study. Site: The Brigham and Women''s Hospital, Inc.
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.
May be responsible for the following activities: making independent judgment of suitability of potential participants for clinical trials, developing and implementing patient recruitment strategies, recommending changes to protocols, managing existing datasets, and overseeing the work of more entry level staff. 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.
p>The Marijuana Investigations for Neuroscientific Discovery (MIND) Program/Cognitive and Clinical Neuroimaging Core (CCNC) is dedicated to studying the relationship between substance use, cognition, and psychiatric disorders using various magnetic resonance imaging (MRI) techniques and neuropsychological, clinical, and diagnostic instruments. May be responsible for the following activities: making independent judgment of suitability of potential participants for clinical trials, developing and implementing patient recruitment strategies, recommending changes to protocols, managing existing datasets, and overseeing the work of more entry level staff.
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. 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.
Boston, Massachusetts19 days ago
p/>Responsibilities include supporting CICU investigators in all of the stages of clinical research: including research initiation, regulatory (IRB) submission, care coordination of subjects, required education of staff, maintenance and adherence to the protocol, monitoring of data, reporting to both sponsor and IRB until close-out of each study.
The Research Assistant II will be involved in coordinating the clinical research activities and quality improvement data management and analysis for the Cardiac Intensive Care Unit (CICU) of the Cardiovascular Division at Brigham and Women’s Hospital.
Equipped with extensive experience in program and system design and implementation; integration of research compliance requirements into operational workflows; formation and leadership of institutional committees and workplan initiatives; and career and cultural development, the Senior Manager, Special Projects, is adept in shifting priorities as needed, ready to take on a wide variety of institutional interests. o Recommend process and systems enhancement to Clinical Trial Office Director and collaborate with BClientHS research and non-research departments to implement changes within Client and BClientHS wide systems, including but not limited to, Epic enhancements and other affiliated system integrations.
Actual compensation is determined based on several factors, that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other applicable factors permissible by law. Compensation may exceed the base hourly rate depending on shift differentials, call pay, premium pay, overtime pay, and other additional pay practices, as applicable to the position and in accordance with the law.
Customer Service: Ability to provide a high level of customer service to patients, visitors, staff and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem solving. Extracts data on protocol subjects from hospital records, outpatient charts and private physician office records in order to complete case report forms required by specific protocols.
p>In close partnership with the Director of Research Governance & Transformation, this role ensures strategic direction is clearly defined and positioned for execution, while maintaining primary ownership of strategy development, prioritization, and decision support, and may provide guidance or informal leadership to project teams or analysts in support of strategic initiatives. POSITION SUMMARY:
The Director, System Research Planning and Performance serves as the strategic engine for research planning across Boston Medical Center Health System, responsible for defining enterprise research priorities, developing growth strategies, and shaping executive-level decision-making related to research expansion, clinical trials, financial performance, and operating model evolution.
p>Responsibilities: • Conducts patient health assessments and medication administration • Obtains IV access through peripheral IV initiation • Prepares and administers a variety of specialized intravenous or injectable pharmacological treatments • Provides study participant care by utilizing the skills of observation, assessment, nursing diagnosis, counseling, health teaching, and reporting any adverse events to immediate supervisor or required stakeholders • Performs routine nursing duties in accordance with company policies and procedures • Performs specialized nursing procedures for which recognized training and current competency have been demonstrated and completed • Observes and documents study participant conditions • Acts as a resource to other Infusion Nurses by providing support and direction as needed • Understands and implements infection prevention practices • Participates in ongoing internal and/or external continuing education activities • Adheres to Headlands EMA policies and procedures • Participates in quality activities and continuous improvement initiatives • Participates in proactive Health & Safety activities while performing all duties • Is responsible to notify immediate Supervisor of any Health & Safety risks or concerns • Maintains confidentiality of client and corporate information • Completes other tasks as requested • Maintains knowledge of study protocols, including inclusion and exclusion criteria for each study protocol in order to assist with screening potential study participants for participation as part of our recruitment process • Contact potential study participants who have requested information on our enrolling studies.
Qualifications:
• Current and unencumbered license as a Registered Nurse (RN) within British Columbia required • Previous experience in a critical care or emergency setting or with providing multiple daily infusions required • Graduated from an accredited nursing education program with a Bachelor of Science in Nursing (BSN) degree or equivalent preferred, but not required • Exceptional peripheral IV initiation skills • Exceptional clinical assessment skills • Strong communication skills • Able to manage relationships with exceptional customer service • Exceptional interpersonal skills and ability to handle difficult situations • Able to work independently and as part of an interdisciplinary team • Able to perform and prioritize multiple functions and tasks • Able to read and interpret technical instructions related to clinical care.