div>
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. 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 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"). 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 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. 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. 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, Massachusetts20 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. 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. Boston, Massachusetts18 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. 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. Boston, Massachusetts14 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.
Charlestown, MA30+ days ago Under the general supervision of MADRC leadership, the Clinical Research Lead is responsible for conducting study visits and managing specific aspects of protocols and policies for the Center's Longitudinal Cohort Study (aka The Memory Study). 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. Cambridge, MA30+ days ago p>If applicable liaise with Regional Clinical Operations team to execute any co-monitoring activities defined for SP oversight and/or set up regular meetings with MSLs (Medical Science Liaison) at LMA (Local Medical Affairs) who may be able to support Clinical Operations at various steps (site qualification, site recruitment). Knowledge & Experience: Significant and relevant experience of pharmaceutical drug development (Ph2, Ph3) including project management of national and international programs OR significant and relevant experience in RWE/HEOR, NIS studies, including project management of national and international programs. p>As the Senior Manager, Clinical Operations- Cardiology at Iterative Health you will serve as a strategic advisor to sponsors, CROs, and research sites, translating operational challenges into scalable solutions that improve study execution, accelerate activation timelines, and drive patient recruitment performance. By combining deep clinical research expertise with a consultative approach, this individual will help strengthen sponsor relationships, elevate site performance across the network, and contribute directly to Iterative Health''s mission of bringing innovative therapies to patients faster. 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. |