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Reporting to the Clinical Research Program Manager (or local Hospital Administrator/Clinic Director) and Research Programs Office at SHC International Headquarters, the CRC provides support in accordance with SHC’s policies and procedures, SHC’s hospital regulations, the Code of Federal Regulation, and Good Clinical Practice guidelines, when applicable. Responsibilities:
The Clinical Research Coordinator, Level 2 (CRC2) is a specialized, independent research professional who ensures oversight and compliance of both system-wide and local SHC clinical research activities. The CRC I administers assists with communication with hospital teams and community partners, team meeting coordination, administrating 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 team in preparation of data and other reports. This includes education, experience, skills, and certifications/licensures as they directly relate to position requirements; as well as business/organizational needs, internal equity, and market-competitiveness. p>The CRA I will perform the following data management duties under general supervision by the Clinical Research Manager: 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 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"). Cambridge, Massachusetts5 days ago p/>We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. The scope includes the operational planning and strategy required to execute end-to-end supply management, including demand planning, label development, packaging/labeling, distribution, IRT UAT/supply management, temperature excursions, and site activations. Brookline, MA30+ days ago This role involves coordinating research studies, maintaining clinical and research databases, recruiting and enrolling participants, assisting with remote and in-person study visits, collecting and managing study data, and collaborating closely with investigators and multidisciplinary research teams. 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. The Clinical Research Coordinator will manage the day-to-day operational requirements of assigned studies, including patient enrollment, protocol adherence, data collection, and regulatory documentation. The position requires direct interaction with study participants, sponsor representatives, and institutional review boards, and demands a working knowledge of FDA regulations and Good Clinical Practice guidelines. p>The Center for Precision Psychiatry (CPP) at Mass General Hospital is seeking applications for a full-time Project Manager to work on projects led by Dr. Matthew Nock aimed at better understanding short-term suicide risk and testing innovative new interventions to prevent suicidal behavior. Ideal candidates will bring strong project management abilities, outstanding written and verbal communication skills, advanced organizational and technology skills, and the ability to work independently while building effective relationships across all levels of the organization. p>Co-authors clinical sections of protocols, clinical investigator brochures, clinical study reports, Worldwide Marketing Application/Common Technical Document (WMA/CTD) subsections, and regulatory agency update and safety reports, as well as clinical development plans, publications, and abstracts. Experience managing Immunology and/or vaccine trials with an ability to think outside of the box, explore novel ways of working and comfortably navigate ambiguity to drive results also a plus. p>You will own core transactional AR workflows, including monitoring sponsor and site-level accounts, supporting timely collections, posting cash in RealTime CTMS, and assisting with invoicing as needed. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need. p>You will own core transactional AR workflows, including monitoring sponsor and site-level accounts, supporting timely collections, posting cash in RealTime CTMS, and assisting with invoicing as needed. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need. Through the Iterative Health Site Network - a premier network of 100+ clinical research sites across the US and Europe - we help expand and expedite access to novel therapeutics for patients in need. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need. 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. The primary role of this position is to assume the responsibility for coordination of the scheduling of tissue procurement within the various clinical trial timelines and ensure that the tissue procurement and processing is carried out per clinical trial laboratory manual specifications. Boston, Massachusetts18 days ago The Clinical Research Associate I (CRA I) works under general supervision to enroll eligible patients to clinical research protocols and manage data collection and regulatory submissions for multiple cancer studies. The CRA I will perform the following data management duties under general supervision by the Clinical Research Manager: · Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria. p>With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. We are looking for a Community Clinical Research Educator II who is deeply passionate about promoting awareness and education of clinical research, and access to clinical trials., to diverse communities. p>Summary: Following established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; performing clinical tests such as phlebotomy, EKGs, etc. and maintaining and updating data generated by the study. The research coordinator's primary responsibility in the MGH Diabetes Research Center will be working on studies related to pregnancy and/or diabetes including those that use oral glucose tolerance testing and continuous glucose monitoring and collect biospecimens. p>Translational Medicine (TMed) drives early clinical development of novel therapeutics by partnering with Discovery Sciences and Late-Stage Clinical Research to translate scientific discoveries into human proof-of-concept and advance the most promising candidates through the pipeline to patients. Leads and directs teams through key study planning, development, and execution activities, including program overviews, issue escalation and mitigation, senior management presentations, cross-functional governance meetings, and advisory meeting preparation. Cambridge, MA30+ days ago p>Experience / Skills: MD or MD/PhD in a relevant scientific discipline, preferably pulmonology, with at least 2 years relevant experience in clinical development within the pharmaceutical industry, academia, or government agencies such as the NIH, FDA, or other equivalent national or international public health and regulatory organization. On Clinical Development, the CRD:
Westborough, MA22 days ago li>Deep expertise in designing and executing global clinical evidence generation programs, including protocol development, study design, endpoint strategy, clinical study report development, and integrated publication planning to support regulatory, reimbursement, scientific, and commercial objectives. In addition to leading evidence generation strategies for product development, regulatory approval, and reimbursement, this role serves as a clinical thought leader, translating complex global insights into actionable strategies that accelerate commercialization and adoption. Boston, Massachusetts12 days ago The Center for Precision Psychiatry (CPP) at Mass General Hospital is seeking applications for a full-time Project Manager to work on projects led by Dr. Matthew Nock aimed at better understanding short-term suicide risk and testing innovative new interventions to prevent suicidal behavior. Ideal candidates will bring strong project management abilities, outstanding written and verbal communication skills, advanced organizational and technology skills, and the ability to work independently while building effective relationships across all levels of the organization. Somerville, Massachusetts16 days ago Working under the guidance of Clinical Study Manager and cross-functional study teams, the SCSA contributes to study operations, documentation, regulatory compliance, and process improvement initiatives. This position often requires sitting, standing, walking, bending, twisting, reaching with hands and arms, using hands and fingers, handling, or feeling, speaking, listening, and high-level cognitive thinking. Responsibilities (including, but not limited to): Accountable for assigned project related efforts for the delivery of studies that are critical to a product's clinical development, supporting the Global Clinical Trial Manager Study Lead) to ensure that studies are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines. BA/BS degree in Health or Life Sciences required (advanced degree preferred) with 4+ years of industry experience with at least 2 of those years in clinical trial management or demonstration of equivalent capability in a Clinical Trials Manager role. 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. 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. p>Requirements: • High school diploma or GED required; Bachelors Degree preferred • Industry-sponsored trial experience strongly preferred (vaccine study experience a plus) • At least one full year of experience coordinating clinical trials phases 1-4 required • Previous hands-on clinical experience caring for patients suffering from neurodegenerative diseases highly preferred • Familiarity with electronic data capture (EDC), IVRS, and other trial platforms • Deep understanding of FDA, ICH-GCP regulations, and clinical trial procedures • Proficiency in medical terminology and clinical documentation practices • Strong interpersonal, verbal, and written communication skills • Organized, detail-oriented, and capable of managing multiple priorities • Proficient in Microsoft Office and other clinical research systems. Headlands Research Eastern Massachusetts is a leading clinical trial research site focusing on the care of patients and their families living with neurodegenerative diseases, memory and movement disorders. Cambridge, MA30+ days ago p>The Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS) Bionics Lab (https://bioniclab.seas.harvard.edu/) is seeking a highly motivated Fellow with a background in Biomedical Engineering, Mechanical Engineering, or Neural Engineering to join our interdisciplinary research team. You will work at the intersection of neuroscience, engineering, and clinical science, gaining hands-on experience with human subject research, robotics, and electrophysiological data analysis, while contributing to impactful translational research. The variety of tasks associated with this position, include, but are not limited to the following: assisting with study administrative tasks such as, IRB communications and document development, site management and startup activities, writing progress reports, scientific writing (including drafting manuscripts, abstracts, posters, and PowerPoint presentations), grant applications, medical chart review, completion of case report forms, data extraction and upload, site staff communication and patient contact for research studies, and maintain the section's OpenScholar website. Smith Center for Outcomes Research, Electrophysiology & Digital Health Section at BIDMC is seeking a highly motivated Clinical Research Coordinator to be responsible for the managing/overseeing of recruiting, screening and enrolling of patients for participation in a multiple clinical trial, ensuring compliance with federal, state and institutional guidelines. |