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.
Providence, RI30+ days ago
The core Success Factors include: Instill Trust and Value Differences Patient and Community Focus and Collaborate RESPONSIBILITIES: Provides assistance to Principal Investigators to coordinate clinical research activities related to department 's field of study and investigators specific study. Using pre-packaged software and according to needs of research supervisor, performs computer-assisted statistical analysis such as multiple antecedent variables, linear regression, frequencies, cross tabulations and the like.
Providence, RI23 days ago
The core Success Factors include: Instill Trust and Value Differences Patient and Community Focus and Collaborate RESPONSIBILITIES: Provides assistance to Principal Investigators to coordinate clinical research activities related to department's field of study and investigators specific study. Using pre-packaged software and according to needs of research supervisor, performs computer-assisted statistical analysis such as multiple antecedent variables, linear regression, frequencies, cross tabulations and the like.
Providence, RI30+ days ago
The core Success Factors include: Instill Trust and Value Differences Patient and Community Focus and Collaborate RESPONSIBILITIES: Provides assistance to Principal Investigators to coordinate clinical research activities related to department's field of study and investigators specific study. Using pre-packaged software and according to needs of research supervisor, performs computer-assisted statistical analysis such as multiple antecedent variables, linear regression, frequencies, cross tabulations and the like.
East Providence, RI9 days ago
The core Success Factors include: Instill Trust and Value Differences Patient and Community Focus and Collaborate RESPONSIBILITIES: Provides assistance to Principal Investigators to coordinate clinical research activities related to department's field of study and investigators specific study. Using pre-packaged software and according to needs of research supervisor, performs computer-assisted statistical analysis such as multiple antecedent variables, linear regression, frequencies, cross tabulations and the like.
li>Follow relevant SOPs and regulations, has an excellent understanding of and complies with applicable trainings, seeks opportunities to further improve quality and efficiency of clinical procedures; leads or actively participates in portfolio- and enterprise level workgroups aimed at optimizing PFE clinical development procedures; may be a subject matter expert or business process owner for a relevant SOP or procedure.
Author protocols, study level informed consent documents, and contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; supports preparations for Health Authority meetings, participates as appropriate.
Massachusetts30+ days ago
div>By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.
Massachusetts30+ days ago
div>By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use.
Drives a fit-for-use global Quality framework that elevates the business units and the affiliate capabilities and enables the affiliates to deliver their clinical research and pharmacovigilance related regulated activities (including evidence generation studies, patient access programs, IIR, collaborative research, RWE/RWD) with high compliance and agility.
The organization partners with healthcare professionals, research teams, and sponsors to deliver high-quality clinical research while maintaining a strong focus on patient safety and regulatory compliance. Candidates who apply for roles through the Atrium website will be added to our candidate pool and may be considered for additional roles of a similar title.
p>If you require reasonable accommodations during the recruitment process, please let us know or submit a request here. Visit our careers site to read more about the benefits ICON offers.
Within 6 months of start date, for positions that perform immunizations or medication administrations in accordance with Rhode Island Board of Pharmacy Rules and Regulations or the Commonwealth of Massachusetts, must possess and maintain an American Council for Pharmacy Education (ACPE) approved Immunization Certification and American Heart Association Basic Life Support (BLS) Certification. Conducts pharmacy practice research, clinical research, and data-related research in alignment with Brown University Health’s mission, goals, and priorities; authors original research-based abstracts, scientific, and scholarly papers and submits for publication and/or presentation in accordance with departmental policies and procedures.
The core Success Factors include: Instill Trust and Value Differences Patient and Community Focus and Collaborate RESPONSIBILITIES: Provides assistance to Principal Investigators to coordinate clinical research activities related to department's field of study and investigators specific study. Using pre-packaged software and according to needs of research supervisor, performs computer-assisted statistical analysis such as multiple antecedent variables, linear regression, frequencies, cross tabulations and the like.
Using pre-packaged software and according to needs of research supervisor, performs computer-assisted statistical analysis such as multiple antecedent variables, linear regression, frequencies, cross tabulations and the like. Brown University Health employees are expected to successfully role model the organization's values of Compassion, Accountability, Respect, and Excellence as these values guide our everyday actions with patients, customers and one another.
The core Success Factors include: Instill Trust and Value Differences Patient and Community Focus and Collaborate RESPONSIBILITIES: Provides assistance to Principal Investigators to coordinate clinical research activities related to department’s field of study and investigators specific study. Using pre-packaged software and according to needs of research supervisor, performs computer-assisted statistical analysis such as multiple antecedent variables, linear regression, frequencies, cross tabulations and the like.
strong>____ About URI The University of Rhode Island enrolls approximately 17,000 students across its graduate and undergraduate programs and is the States flagship public research university as well as the land grant and sea grant university for the state of Rhode Island. ____ Department Information Department: Pharmacy Practice and Clinical Research Contacts Please note: Job applications must be submitted directly online only at https://jobs.uri.edu
Foxborough, MA30+ days ago
p>The Clinical Research Coordinator II (CRC II) will work within the Dana-Farber Foxborough Satellite 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(s) and the DFCI disease programs. Responsible for data reporting and management, collection of source documents, use of case report forms, adverse events reporting, filing and archiving of study records, and resolution of data queries for all studies at the Satellite site(s).
li>Follow relevant SOPs and regulations, has an excellent understanding of and complies with applicable trainings, seeks opportunities to further improve quality and efficiency of clinical procedures; leads or actively participates in portfolio- and enterprise level workgroups aimed at optimizing PFE clinical development procedures; may be a subject matter expert or business process owner for a relevant SOP or procedure.
Author protocols, study level informed consent documents, and contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; supports preparations for Health Authority meetings, participates as appropriate.
li>Follow relevant SOPs and regulations, has an excellent understanding of and complies with applicable trainings, seeks opportunities to further improve quality and efficiency of clinical procedures; leads or actively participates in portfolio- and enterprise level workgroups aimed at optimizing PFE clinical development procedures; may be a subject matter expert or business process owner for a relevant SOP or procedure.
Author protocols, study level informed consent documents, and contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; supports preparations for Health Authority meetings, participates as appropriate.
div>By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.
Providence, RI30 days ago
Three years of progressively more responsible post-graduate experience, preferably gained in a similarly diverse and operationally complex health system with robust ambulatory care pharmacy servicesORBoard certification in specialty or Pharmacotherapy in conjunction with five years of progressively more responsible post-graduate experience, preferably gained in a similarly diverse and operationally complex health system with robust ambulatory care pharmacy services. Provides accurate communication, both written and verbal as appropriate.109820397Maintains knowledge of, and expertise in, leading edge developments in pharmacotherapeutics, pharmacoeconomic principles, and pharmaceutical care concepts,Serves as a subject matter expert and real-time go to resource in area of specialty.
Provides clinical guidance to the development of the clinical data collection strategy, instruments, and data review plan, ensuring alignment with the protocol and SAP, optimized data collection principles, and clinical data review best practice; sets the clinical data review strategy and leads the team in the review of emerging clinical data and trends; reviews and queries data; presents data to internal and external stakeholders; partners with site-facing colleagues in support of data issue resolution; ensures all clinical queries are appropriately addressed in support of database lock. Provides clinical guidance to the development of the Safety Review Plan and Safety Narrative Plan; reviews safety data and ensures clinical documents are updated in response to emerging safety profile; tracks and reconciles Serious Adverse Events; leads clinical safety data discussion during Safety Review Team meetings in collaboration with Medically Qualified Individual(s); reviews safety narratives.
Provides clinical guidance to the development of the clinical data collection strategy, instruments, and data review plan, ensuring alignment with the protocol and SAP, optimized data collection principles, and clinical data review best practice; sets the clinical data review strategy and leads the team in the review of emerging clinical data and trends; reviews and queries data; presents data to internal and external stakeholders; partners with site-facing colleagues in support of data issue resolution; ensures all clinical queries are appropriately addressed in support of database lock. Provides clinical guidance to the development of the Safety Review Plan and Safety Narrative Plan; reviews safety data and ensures clinical documents are updated in response to emerging safety profile; tracks and reconciles Serious Adverse Events; leads clinical safety data discussion during Safety Review Team meetings in collaboration with Medically Qualified Individual(s); reviews safety narratives.
Assesses scientific, medical, and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner/acquisition companies during DD visits and alliance negotiations, and representing clinical science on internal assessment teams in conjunction with TPNA/TPEU/TPC. By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use.
Assesses scientific, medical, and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner/acquisition companies during DD visits and alliance negotiations, and representing clinical science on internal assessment teams in conjunction with GPLS & Business Units. By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use.
div>By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use.
Provides leadership in meetings and negotiations with key opinion leaders, establishment of strategy for assigned compounds, and the direction of clinical scientists involved in developing documents required to outline the Company positions on research programs or regulatory applications (e.g.
li>Serves as a member of the clinical study team and as a biomarker subject matter expert for executing clinical study setup & conduct, contributing to the study protocol development and review, clinical development plans, preparing submissions, addressing regulatory queries, developing commercial differentiation strategies, implementing biomarker bioanalytical strategies & assays, and delivering regulatory compliant data and reports within program timelines.
Contributes to and reviews clinical protocols, clinical development plans, bioanalytical plans and report documents, biomarker statistical analysis plans, budgeting and invoicing, health agency submissions, lab manuals, CRF and data transfer specifications, commercial differentiation strategies and informed consent language document sections specific to biomarkers in compliance with clinical SOPs & policies, and regulatory guidance.
Provides clinical guidance to the development of the clinical data collection strategy, instruments, and data review plan, ensuring alignment with the protocol and SAP, optimized data collection principles, and clinical data review best practice; sets the clinical data review strategy and leads the team in the review of emerging clinical data and trends; reviews and queries data; presents data to internal and external stakeholders; partners with site-facing colleagues in support of data issue resolution; ensures all clinical queries are appropriately addressed in support of database lock. Provides clinical guidance to the development of the Safety Review Plan and Safety Narrative Plan; reviews safety data and ensures clinical documents are updated in response to emerging safety profile; tracks and reconciles Serious Adverse Events; leads clinical safety data discussion during Safety Review Team meetings in collaboration with Medically Qualified Individual(s); reviews safety narratives.
Woonsocket, RI30+ days ago
The Vice President, Data Strategy & Clinical Intelligence, will report to the EVP, Chief Medical Officer of CVS Health, will create a high-performing analytics team, forge productive partnerships with the enterprise Data & Technology team, establish the frameworks and infrastructure to measure Medical Affairs' contribution to enterprise goals, and serve as the medical affairs representative to enterprise AI governance, with specific responsibility for clinical safety and quality of AI applications. Partner with business units, Digital, Data & Technology, and Finance to establish rigorous, enterprise-accepted definitions for critical clinical metrics-including prior authorization burden, decision quality, days spent at home, clinical outcomes by care journey, total cost of care attributable to clinical initiatives, and safety outcomes.
p>To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on
Pfizer Careers.
Experience applying AI, machine learning, or advanced analytics in clinical development or research (e.g., protocol design and optimization, site selection and feasibility assessment, query management and workflow automation, data cleaning, anomaly detection, and signal identification, safety risk prediction and proactive mitigation).
p>Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act.
Providence, RI23 days ago
The core Success Factors include: Instill Trust and Value Differences Patient and Community Focus and Collaborate In addition, our leaders will demonstrate an aptitude for: Ensure Accountability and Build Effective Teams Drive Vision and Purpose and Optimize Work Processes By applying core and leadership competencies, leaders help Brown University Health achieve its strategic goals. Brown University Health employees are expected to successfully role model the organization's values of Compassion, Accountability, Respect and Excellence, as these values guide our everyday actions with patients, customers and one another.
Duties include but are not limited to oversight of all research-related activities, screening and evaluation of prospective trial patients, clinical follow-up of enrolled trial patients, correspondence and coordination with the Institutional Review Board and trial sponsors. Nestled in local communities, Southcoast Health provides inclusive, ethical workplaces where our highly skilled caregivers offer world-class, comprehensive healthcare close to home.
The core Success Factors include: Instill Trust and Value Differences Patient and Community Focus and Collaborate In addition, our leaders will demonstrate an aptitude for: Ensure Accountability and Build Effective Teams Drive Vision and Purpose and Optimize Work Processes By applying core and leadership competencies, leaders help Brown University Health achieve its strategic goals. Brown University Health employees are expected to successfully role model the organization’s values of Compassion, Accountability, Respect and Excellence, as these values guide our everyday actions with patients, customers and one another.
Provides clinical input to the development of the clinical data collection strategy, instruments, and data review plan, ensuring alignment with the protocol and SAP, optimized data collection principles, and clinical data review best practice; performs clinical data review; may present data to internal and external stakeholders; partners with site-facing colleagues in support of data issue resolution; ensures all clinical queries are appropriately addressed in support of database lock. Provides clinical input to the development of the Safety Review Plan and Safety Narrative Plan; reviews safety data and may update clinical documents in response to emerging safety profile; tracks and reconciles Serious Adverse Events; participates in clinical safety data discussion during Safety Review Team meetings in collaboration with Medically Qualified Individual(s); reviews safety narratives.
We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.