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.
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Bridgewater, MA5 days ago
This position coordinates effective administration of SOT services as further described below and provides administrative guidance and support to site SOT staff, reporting to the Director of Sex Offense Specific Program Services. VitalCore Health Strategies (VCHS), an industry leader in Correctional Health Care has an opening for a Full-Time Clinical Director in our Sex Offender Treatment Program at the Massachusetts Treatment Center in Bridgewater, MA.
Project Manager and team members with all phases of clinical research, including Trial Initiation, Coordination, Implementation, Maintenance, and Close-out. System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America.
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.
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.
strong>Key Responsibilities- Lead the day-to-day operations, supervision, and development of the Clinical Research team, ensuring staff have the training, resources, and support needed to successfully recruit participants and execute study activities across a portfolio of research studies.
- Provide ongoing performance management, coaching, and guidance to clinical research staff while ensuring adherence to study protocols, institutional policies, and regulatory requirements; collaborate closely with Principal Investigators to address study needs and priorities.
p>The Clinical Research Coordinator II (CRC II) supports all phases of the study lifecycle, conducts patient recruitment, consenting, administers questionnaires, abstracts medical records, procures, processes and ships research specimens, 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. The CRC-II procures, processes and ships research specimens and conducts patient recruitment/consenting, 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.
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.
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. experience with site management, study management, IRBs, and federal regulations regarding clinical research compliance requiredExperience in the coordination of intergroup or multi-site clinical studies preferred.
These positions, in collaboration with the program's Clinical research Managers physicians and research nursing staff, are responsible for assisting with the design, implementation and evaluation of their program's clinical research activities, related regulatory oversight, and will provide day to day supervision of their program's clinical research staff as needed. This Assistant Clinical Research Manager (ACRM) position will work within the Breast Oncology clinical research program and assist in the management of the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator.
Cambridge, MA30+ days ago
The position combines strong digital and AI domains with function-level business and transformation leadership, requiring the ability to produce decision-grade insights for CSO leadership, translate complex technology and regulatory constraints into strategic value hypotheses, and steer outcomes across highly matrixed, regulated environments. Direct and validate: Competitive and technology intelligence to inform strategic positioning, function-level business needs and value hypotheses, prioritization of business-driven requirements shaping product and roadmap decisions & gaps analysis against existing solutions and operating models.
For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions.
Performs office-related duties such as answering phones, picking up and delivering mail, storing and distributing office supplies, handling faxes, scanning, filing, photocopying, collating materials, maintaining the update of policy manuals, etc. 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.
This position will work both independently and collaboratively with a variety of personnel at all levels, including faculty and study team members of BMC/BU and other external institutions, cooperative groups, clinical trials experts, representatives from the pharmaceutical industry, federal agencies, and other research organizations. Contributing to a culture of compliance, the RC works interactively with CHCRP clinical research staff, leadership, the Office for Human Research Studies (OHRS), BMC Clinical Trial Office, ancillary departments supporting CHCRP clinical trials, and is responsible for the proactive initiation and fulfilment of regulatory compliance within CHCRP.
As needed, provide age specific care to pediatric and adult patients with or without diabetes mellitus in a collaborative practice, by using competencies in history taking, physical examination, assessment and interpretation of laboratory and related diagnostic tools for purposes of screening and safety assessments of participants participating in clinical research studies. The Joslin Clinic Research Center Manager is a practitioner who provides care as well as supervision, management, and leadership to support the daily operations and future direction of the Joslin Clinical Research Center (CRC).
p>As the Senior Manager, Clinical Operations- GI 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. We built a leading performance-driven network of 100+ sites across the US, Europe, India, and Australia, conducting research directly in the communities where care is delivered across gastrointestinal, hepatology, obesity, and cardiology.
p>We are seeking an expert Senior Program Manager of Clinical Research Operations to provide high-level operational, regulatory, and strategic management across multiple active research projects. With the pay range(s) shown above, the starting salary will depend on several factors, which may include your education, experience, location, knowledge and expertise, and skills as well as a pay comparison to similarly-situated employees already in the role.
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.
div class="content-pay-transparency">New York pay range
$140,000—$165,000 USD
At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves.
As the Senior Manager, Clinical Operations- GI 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.
Boston, Massachusetts30+ days ago
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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. Cambridge, MA30+ days ago The CES Ops portfolio is dynamic in nature; study types include, but are not limited to, less complex data transfer agreements, retrospective sample/data acquisition studies to more complex prospective studies including sample/data acquisition, biomarker/technology/method validation, genotypic/phenotypic call back studies, and challenge/screening studies. A typical day in this role looks like: - Leads the cross-functional study team responsible for clinical study/research collaboration delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study.
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"). 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. p>The CRA I will perform the following data management duties under general supervision by the Clinical Research Manager: 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>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>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. 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. 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. 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>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. 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. 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. 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:
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, 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. Somerville, Massachusetts17 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. 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. 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. |