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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. 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. p>The CRA I will perform the following data management duties under general supervision by the Clinical Research Manager: 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. 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. Westborough, MA23 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, Massachusetts19 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. 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. 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. 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. Boston, Massachusetts17 days ago li style="margin-left:0.5in">Manage CROs, EDC vendors, central labs, imaging vendors, eCOA providers, IRT vendors, and other data providers. Review and contribute to key study documents, including data management plans, edit check specifications, CRF completion guidelines, data transfer agreements, and data review plans. 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. Boston, Massachusetts13 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. p>The Clinical Research Agreements team manages the contract negotiation of industry-sponsored clinical trial agreements, industry funded investigator-initiated clinical trial agreements, any other type of industry funded clinical research agreements, and data use agreements, regardless of the source of funding. - Drafts and negotiates written clinical research related agreements with corporate sponsors and other outside entities Conducts negotiation of complex clinical research agreements and attends to relevant terms.
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. Cambridge, Massachusetts6 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. 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 CRC (Clinical Research Coordinators) 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 and the Clinical Research Manager. 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. Andover, Massachusetts30+ days ago ul>Competencies and Personal Traits:- What We Do:
- Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work.
- Why We Do It:
- Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world.
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>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. 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. |