Collecting information
Organizing data
The Clinical Research Nurse, ensures that the health and safety of research participants and the integrity and quality of clinical trials, are maintained and conducted in accordance with federal, state, IRB, departmental, and institutional regulations, policies and procedures. The Clinical Research Nurse will primarily provide nursing expertise and care to research study patient management with primary focus on bone marrow transplantation and cellular therapy clinical trial protocols. They will serve as a liaison and work closely with investigators, department members, study sponsors, IRB and the institution, to support administration of compliance, financial, personnel and other related aspects of all ongoing clinical studies. Minimum 2 years’ experience in Pediatric Bone Marrow Transplant/Hematology-Oncology nursing required.. Knowledge of Institutional Review Board (IRB) policies and procedures
The Nurse Manager (Patient Care Manager) is a Registered Nurse who provides unit leadership and works in partnership with nursing, the healthcare team, hospital/system leaders to develop a quality practice setting that support professional nursing and quality patient care.. The Nurse Manager is accountable for the effective delivery of competent, compassionate, and efficient patient care on a 24-hours a day, seven days a week basis.. Responsibilities include coordination of patient care; supervision of a professional team that includes multiple nursing and other staff as appropriate; administrative and budget management; troubleshooting of problem areas; organizational change management; ensuring compliance with accreditation and regulatory standards; quality assurance/quality improvement; safety and risk management requirements as well as actualization of hospital and unit policies, goals and objectives.. Employees must abide by all Joint Commission Requirements including but not limited to sensitivity to cultural diversity, patient care, patient rights and ethical treatment, safety and security of physical environments, emergency management, teamwork, respect for others, participation in ongoing education and training, communication and adherence to safety and quality programs, sustaining compliance with National Patient Safety Goals, and licensure and health screenings.. Salary within our ranges may also be determined by your education, experience, knowledge, skills, location, and abilities, as required by the role, as well as internal equity and alignment with market data.
Medicare Reimbursement Manager.. A leading healthcare organization is seeking a Medicare Reimbursement Manager to oversee reimbursement processes related to Medicare, Medicaid, Tricare, and other government cost reports for multiple facilities. Manage and review Medicare, Medicaid, and Tricare cost reports, ensuring accuracy and compliance. Act as a financial liaison on reimbursement matters, compliance, and charge master oversight. Knowledge of IME, GME, Transplant, DSH, and Wage Index is a plus.
A leading clinical research organization dedicated to advancing healthcare through patient-centric clinical trials and studies is looking for a Business Development Director to join the team. A dynamic sales professional with experience in clinical research business development is sought for a full-time, remote role (with occasional travel). This individual will drive new business growth, build strategic partnerships, and expand clinical trial opportunities. Secure new business opportunities in site-based, hybrid, and fully decentralized clinical trials. Proven sales experience in clinical research, with a track record of closing deals.
Medica's Lead Analyst, Healthcare Analytics provides reporting and analytical support to strategic employer group partners.. 3+ years' experience using SQL, SAS or Snowflake programming experience. Strong proficiently in data analysis tools and visualization techniques/software (e.g. QlikSense, Power BI, Tableau). John Hopkins ACG Grouper, Milliman HCG Grouper, Symmetry ETG Grouper. Frequency is determined by business need as decided by leadership and may be up to 2-3 days a week.
The Director, Regulatory Strategy is responsible for the assigned brand programs and all strategic decisions to include providing regulatory pathway for the development, preview of clinical, non-clinical and CMC development as needed, act as US agent and communicate with the agency, interact suitably with CROs and all other stakeholders as applicable.. Provide strategic, tactical, and operational direction and guidance for product’s pipeline and key regulatory milestones.. that could have an impact on product development to assess approval pathways and issues.. The Regulatory Strategist/Lead should always be the point of contact and lead this interaction.. Ensure that communication that is documented per established procedure should be distributed within the Global Regulatory Affairs team and any other external department that is directly affected by the communication.
This individual will partner with CMC, Clinical, Regulatory Affairs, and other corporate stakeholders to ensure Company’s clinical and commercial products follow cGMP framework and guidelines.. The Associate Director, Quality Assurance will be based in our Northern New Jersey, offices 1 - 2 days a week (flexible schedule for the ideal candidate).. Key Responsibilities Provide quality leadership, strategy, and compliance oversight to CDMOs, CMO, CRO, CPO, Third Party Vendors.. ·Performs disposition activities for manufactured products in support of clinical products, including MBR, EBR review, and approval and review of CoA. Responsible for Management and maintenance of the Veeva Quality Docs System, including document drafting/Authoring, reviewing, approving, and finalizing internal quality documents (SOPs, Wis, Policies, Forms, etc.). Ideal candidate will have extensive CMC (Organic and/or Analytical chemistry) experience with at least 10 years in CMC-QA leadership roles.
Voyager Therapeutics, Inc. (Nasdaq: VYGR) is a biotechnology company dedicated to leveraging the power of human genetics to modify the course of – and ultimately cure – neurological diseases.. Many of our programs are derived from our TRACER™ AAV capsid discovery platform, which we have used to generate novel capsids and identify associated receptors to potentially enable high brain penetration with genetic medicines following intravenous dosing.. Some of our programs are wholly owned, and some are advancing with partners including Alexion, AstraZeneca Rare Disease; Novartis Pharma AG; Neurocrine Biosciences, Inc.; and Sangamo Therapeutics, Inc. For more information, visit www.. Develop and implement document templates, style standards, reference library, reviewer guidelines, SOPs and quality control checklists, to ensure consistent and high-quality deliverables. Responsible for clinical trial transparency and disclosures, including clinical trials results posting on clinicaltrials.gov, EudraCT, and similar databases worldwide, in collaboration with Regulatory Affairs and Clinical Operations
Pay Rate: $50 - $55/Hour FUNCTION: Clinical Operations Biomarker and Bioanalytical Operations POSITION OVERVIEW: Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all therapeutic areas.. EXAMPLE RESPONSIBILITIES: Leads or manage components of Phase I, II or III studies Assists Biomarker Sciences, Clinical Virology, and/or Clinical Pharmacology in vendor selection and coordinates all interactions and deliverables from vendors.. Participates in the functional review of study protocol and other study related documents such as clinical sample management plan, study communication plan, or presentations for Investigator and/or Study Kick-Off meeting.. MINIMUM EDUCATION & EXPERIENCE: MA/ MS / PharmD / PhD with 2 + years relevant clinical or related experience in life sciences.. Complete knowledge of Food & Drug Administration (FDA) and European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, Good Clinical Practice (GCP) and key Clinical Operations principles, concepts, practices, standards, processes and tools.
Job Title: Clinical Research Coordinator Job Description The Clinical Research Coordinator, under limited supervision, plans, coordinates, evaluates, and performs the care of participants and collects data for assigned research projects.. The CRC-II (Non-RN) follows study-specific protocol guidelines, communicates with Principal Investigators (PI), Sub-Investigators (Sub-I), Clinical Research Lead, and clinical research support staff.. The CRC advocates for the patient while adhering to industry-sponsored and investigator-initiated clinical trials in accordance with trial protocols, FDA regulations, and ICH/GCP guidelines.. Requirements 1+ years oncology experience RN License Required Soft Skills Positive interpersonal communication skills Effective communication with healthcare team Patient advocacy Independent work Timely documentation Environment This is a fully on-site position in Orlando, Florida.
This individual will partner with CMC, Clinical, Regulatory Affairs, and other corporate stakeholders to ensure Company’s clinical and commercial products follow cGMP framework and guidelines.. The Associate Director, Quality Assurance will be based in our Northern New Jersey, offices 1 - 2 days a week (flexible schedule for the ideal candidate).. Key Responsibilities Provide quality leadership, strategy, and compliance oversight to CDMOs, CMO, CRO, CPO, Third Party Vendors.. ·Performs disposition activities for manufactured products in support of clinical products, including MBR, EBR review, and approval and review of CoA. Responsible for Management and maintenance of the Veeva Quality Docs System, including document drafting/Authoring, reviewing, approving, and finalizing internal quality documents (SOPs, Wis, Policies, Forms, etc.). Ideal candidate will have extensive CMC (Organic and/or Analytical chemistry) experience with at least 10 years in CMC-QA leadership roles.
As part of Mercer, the Government Human Services Consulting (GHSC) team offers its expertise within a small business atmosphere We will count on you to: ·Be a client-facing consultant with expertise in Medicaid facility reimbursement design and rate setting and implementation, with a focus on nursing facility reimbursement.. ·Guide clients in all areas of a reimbursement methodology design, such as: rate setting design and development, Medicaid/Medicare cost report collection, stakeholder partnering, State implementation and operations and establishment of strategic plans/goals, data validation and analysis, and regulation implementation.. ·Some level of nursing home or hospital administration experience.. Mercer, a business of Marsh McLennan (NYSE: MMC), is a global leader in helping clients realize their investment objectives, shape the future of work and enhance health and retirement outcomes for their people.. Marsh McLennan is a global leader in risk, strategy and people, advising clients in 130 countries across four businesses: Marsh, Guy Carpenter, Mercer and Oliver Wyman.
This individual will partner with CMC, Clinical, Regulatory Affairs, and other corporate stakeholders to ensure Company’s clinical and commercial products follow cGMP framework and guidelines.. The Associate Director, Quality Assurance will be based in our Northern New Jersey, offices 1 - 2 days a week (flexible schedule for the ideal candidate).. Key Responsibilities Provide quality leadership, strategy, and compliance oversight to CDMOs, CMO, CRO, CPO, Third Party Vendors.. ·Performs disposition activities for manufactured products in support of clinical products, including MBR, EBR review, and approval and review of CoA. Responsible for Management and maintenance of the Veeva Quality Docs System, including document drafting/Authoring, reviewing, approving, and finalizing internal quality documents (SOPs, Wis, Policies, Forms, etc.). Ideal candidate will have extensive CMC (Organic and/or Analytical chemistry) experience with at least 10 years in CMC-QA leadership roles.
Description The Adjunct Professor, Healthcare Administration (AAS) is a part-time, faculty position responsible to the Department Chair, Healthcare Administration and Dean, School of Nursing &Health Sciences.. Meeting all the needs for the online course or hybrid course(depending on what is assigned).. Informing students of course objectives, performance objectives, class procedures, and grading policies at the beginning of each semester.. Qualifications Bachelor’s degree in Health Information Technology, Healthcare Administration or Business Management.. Proficiency in interpersonal verbal and non-verbal communication and diplomacy.
Description West Virginia University Research Corporation is seeking applications for a Clinical Research Specialist with the Rockefeller Neuroscience Institute (RNI) About the Opportunity The Rockefeller Neuroscience Institute at West Virginia University is seeking applications for a Clinical Research Specialist for the translational clinical trials team.. Current research includes the role of MR guided focused ultrasound, transcranial magnetic stimulation, deep brain stimulation and blood-brain-barrier disruption in the diagnosis and treatment of Alzheimer’s disease, Parkinson’s disease, tremor, substance use disorder, dementia and other neurodegenerative disorders.. As a Clinical Research Specialist, you will drive progress with the multidisciplinary WVU Rockefeller Neuroscience Institute’s Innovation Center team.. In this role, your efforts will provide research support related to neuroimaging to the multidisciplinary scientific team in order to advance rapidly evolving work of a four year old Institute which has seen exponential growth in publications, grants, and IP for work that provide a foundation to improve lives of people in West Virginia and around the globe.. Human subjects' protection and related issues - knowledge of professional principles (GCP and IRB guidelines), legal and/or reporting requirements affecting grants and contracts and adheres to industry and government standards.
As a Moffitt Clinical Research Coordinator, you’ll bring hope to patients by delivering tomorrow’s cancer treatments today!. Associate Clinical Research Coordinator: Associates degree required, in lieu of Associates degree 2 years of relevant experience with a high school diploma or GED. Experience with data entry, good oral and written communication skills and organizational skills.. Clinical Research Coordinator II: Bachelor's degree with 2 years clinical trials coordination experience.. Clinical Research Coordinator III: Bachelor’s degree with 4 years of experience in clinical trials coordination.. CCRP/CCRC certification required Clinical Research Coordinator Sr.: Bachelor's degree with 6 years of experience in clinical trial coordination.
As a not-for-profit organization, Mass General Brigham is committed to supporting patient care, research, teaching, and service to the community. Therefore, we invite and welcome applicants from traditionally underrepresented groups in healthcare — people of color, people with disabilities, LGBTQ community, and/or gender expansive, first and second-generation immigrants, veterans, and people from different socioeconomic backgrounds – to apply. 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; conducting literature reviews; completing IRB applications, and contributing to manuscript preparation, writing, and publishing of studies related to homelessness and mental illness. Recruiting patients for clinical trials, conducts phone. Assists with regulatory binders and QA/QC Procedures.
The Clinical Research Coverage Analyst is responsible for providing assistance to departments in the development of budgets for clinical trials based on coverage determinations and educates departments regarding proper research patient care billing process.. This position reports to the Associate Director - ORA Clinical Research.. Work closely with the School of Medicine Institutional Review Board to ensure research patient care costs are identified and informed consents are consistent with clinical research protocols and commercial contracts if applicable.. Serve as liaison to external auditing activities by the federal government, the Universitys external auditor, or third-party insurers as related to research patient care billing.. Diversity and Inclusion The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the.
The Vice President (VP) of Global Clinical Operations is responsible for the strategic leadership, planning, and execution of global clinical trials across all phases of drug development.. Partner with Regulatory Affairs, Medical Affairs, and Biostatistics to ensure alignment between clinical development and regulatory strategies.. Lead inspection readiness efforts and provide oversight for regulatory submissions (IND, NDA/BLA, MAA).. Proven leadership experience managing global clinical trials across multiple therapeutic areas (preferably Ophthalmology and Nephrology).. PYC is currently conducting early-stage clinical trials with PYC-003, a treatment that could arrest the disease course of ADPKD and enable regeneration and restoration of kidney function.
The Director of Biostatistics provides leadership and guidance as the statistical expert on a project team or within a therapeutic area.. This position is for a qualified statistician/biostatistician to support Clinical Biostatistics within Global Development.. The incumbent will lead and/or oversee the efforts of the Biostatistics department with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints and frame statistical approaches to address those questions, design clinical experiments and interventional studies to generate and analyze the resulting data, and work with teams to appropriately interpret the results and make decisions.. Interacts with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, Medical Writing, and others to design and analyze clinical trials, as well as ensure the clinical program is appropriately designed.. Knowledge of drug discovery and development and ability to integrate statistical concepts into drug discovery and development strategies.