Clinical Research

• Devising the clinical pharmacology and model informed drug development strategy via application of quantitative methods to integrate knowledge of nonclinical data (e.g., metabolism, BCS classification, pharmacology, safety), PK, PD (e.g., biomarker, efficacy, and/or safety), patient characteristics, disease states, competitive landscape, and drug interactions to influence go/no go decisions, support sub-population, dose and dosage regimen selection, and optimize study designs throughout drug development.
• Translate quantitative knowledge into strategic opportunities to influence development along the model-informed drug development principles.
• Planning and performing, or providing oversight, for appropriate analyses (e.g., non-compartmental, population and/or modelling and simulation analysis of PK and/or PD data) of preclinical-clinical translation and dose/exposure-response relationships, to guide dose regimen and optimize study design.
• Planning, summarization and interpretation of results of PK and PK/PD analyses with respect to their impact on a development program and clinical use.
• Planning and delivery of scientifically robust and efficient clinical pharmacology strategies for development candidates.
• Carries out functional responsibilities in accordance with applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles.
• Planning, conducting, and/or providing oversight of PK and PK/PD analyses and reporting.
• Devising clinical pharmacology strategy including design of Phase I clinical pharmacology studies and/or use of alternate modeling approaches, consistent with regulatory guidelines.
• Managing and/or supervising elements of CPP studies.
• Developing key product differentiation strategies based on a compound’s key attributes and relevant therapeutic landscape.
• Defining regulatory strategy for CPP and prepare CP contributions to regulatory documents including IBs, IND’s, briefing books, submission packages, responses to health authority questions, and other regulatory documents.
• Represent CP in relevant external regulatory meetings (e.g., End of Phase 2, pre-NDA / MAA, Advisory Committee meetings).
• Participating in the evaluation of potential business development opportunities.
• Contributing to the knowledge of clinical pharmacology, model informed drug development, analysis methodology and overall drug development process, including regulatory guidance, and methods in modelling and simulation by engaging with the scientific community (e.g., publishing, presenting at meetings, participating in special interest groups within professional societies, etc.) and identify new opportunities for applied scientific and technical advancement within the department.
• Working effectively in team environments, managing CP deliverables in accordance with timelines and overall project goals.

Principal Scientist, Clinical Pharmacology – Pharmacometrics

• Works with Medical Director to develop medical plans
• Engages with outside experts/consultants/advisors
• Performs regular and ad-hoc medical review of data listings
• Authors medical data queries
• Partners with Medical Directors for medical data review meetings
• Manages project scope of work
• Collaborates with study team members

Clinical/Medical Scientist – Oncology – Gynecologic Malignancies

• Support the execution of clinical trial protocols of the clinical development plan, ensuring compliance with scientific, organizational, and regulatory standards.
• Support end-to-end delivery of clinical trial protocols, including study design, initiation, medical data monitoring, data dissemination, and closeout activities.
• Co-manage and coordinate trial activities with internal, cross-functional and external (e.g., vendors, clinical sites) partners to ensure timely execution of clinical trials and to ensure the quality and integrity of data is critical to the evaluation of study endpoints.
• Support providing training on study protocol, disease evaluation criteria, and other essential components to enhance the understanding of clinical development processes.
• Support the review, interpretation, and reporting of clinical trial data, assisting with ensuring accuracy and integrity for health authority submissions.
• Contribute to the preparation of documents for reporting clinical trial data (e.g. clinical study reports, patient narratives, investigator brochures, and periodic safety updates).
• Contribute to the medical data monitoring activities in partnership with the Study Responsible Physician, including the evaluation, documentation, and reporting of ongoing clinical trial data per defined medical data review plan.
• Contribute to process improvements and implementation of best practices in clinical trial execution.
• Collaborate with cross-functional partners to support clinical strategies with overall product development goals.
• Contribute to the preparation and presentation of the results of clinical research in internal department/ management meetings.
• May also support the preparation of materials for external expert engagements.
• Develop and maintain relationships with internal and external stakeholders, including senior management, cross-functional trial teams, and external partners/vendors (e.g. CRO).

Clinical Scientist, Manager – Translational Science and Medicine, Immunology

• Support the execution of clinical trial protocols of the clinical development plan, ensuring compliance with scientific, organizational, and regulatory standards.
• Support end-to-end delivery of clinical trial protocols, including study design, initiation, medical data monitoring, data dissemination, and closeout activities.
• Co-manage and coordinate trial activities with internal, cross-functional and external (e.g., vendors, clinical sites) partners to ensure timely execution of clinical trials and to ensure the quality and integrity of data is critical to the evaluation of study endpoints.
• Support providing training on study protocol, disease evaluation criteria, and other essential components to enhance the understanding of clinical development processes.
• Support the review, interpretation, and reporting of clinical trial data, assisting with ensuring accuracy and integrity for health authority submissions.
• Contribute to the preparation of documents for reporting clinical trial data (e.g. clinical study reports, patient narratives, investigator brochures, and periodic safety updates).
• Contribute to the medical data monitoring activities in partnership with the Study Responsible Physician, including the evaluation, documentation, and reporting of ongoing clinical trial data per defined medical data review plan.
• Contribute to process improvements and implementation of best practices in clinical trial execution.
• Collaborate with cross-functional partners to support clinical strategies with overall product development goals.
• Contributes to the preparation and presentation of the results of clinical research in internal department/ management meetings.
• May also support the preparation of materials for external expert engagements.
• Develop and maintain relationships with internal and external stakeholders, including senior management, cross-functional trial teams, and external partners/vendors (e.g. CRO).

Clinical Scientist – Manager, Translational Science and Medicine – Immunology

• Key member of an early development team, providing leadership in designing and executing early clinical development strategy
• Development and execution of early clinical strategy for novel therapeutics including authoring initial clinical and biomarker plans for Lead Optimization programs
• Development and execution of studies to validate clinical platforms utilizing established and novel biomarkers
• Provide clinical expertise for identification and validation of novel targets
• Safe and timely execution of Phase I studies
• Provide clear, timely communication and interpretation of study results to therapeutic area governance
• Contribute to assessment of internal and external opportunities identified by Business Development and Licensing
• Interface broadly with key functions throughout research sites around the world

Principal Scientist, Clinical Research

• Serve as the CSS therapeutic area lead for the vaccine and infectious disease (VID) projects
• Provide statistical leadership and support to the Risk Management and Safety Teams (RMSTs) in the strategic planning and execution of compound level safety evaluation across product life cycle in vaccine and drug programs
• Design, develop and implement innovative statistical methods and tools for safety evaluation
• Partner with Clinical Safety Risk Management, Early/Late Development Statistics, Epidemiology, Programming, and other RMST functions to plan and execute on aggregate safety evaluation in vaccine and drug projects
• Ensure safety deliverables meet analysis requirements, relevant SOPs and regulatory guidance
• Communicate safety-analysis results and recommendations to teams, management, regulators, and investigators
• Develop processes, job aids, statistical methods, and tools for safety evaluation that address scientific and business needs

Principal Scientist, Biostatistics – Clinical Safety Statistics

• Help develop individual clinical studies according to the clinical development plan within the assigned therapeutic area
• Provide scientific input for the safe and efficient execution of assigned studies, ensuring the highest quality and full compliance of all outputs
• Help develop high-quality program and study level documents and training materials aligned with project plans (e.g. clinical development plan, IB, protocols, eCRF, ICF, study reference manuals, investigator trainings, clinical study report and regulatory submission documents) in compliance with federal regulations, GCP and good medical practice
• Provide clinical science input into design and review of eCRF, SAP, and TLFs
• Support the scientific data analysis and interpretation and help write clinical study reports, internal and external scientific meeting presentations, and publications
• Support the medical monitoring and oversight of individual clinical studies with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, including ongoing review of blinded data, use of data visualization tools and programmed reports
• Identify clinical data trends, issue and resolve corresponding queries, ensure consistency of medical coding and other important data and identification of cases for medical review
• Ensure all questions / issues requiring medical oversight are brought to the attention of the Medical monitor
• Manage the processes and partnerships required to support external study oversight committees (e.g. Steering committee, independent data monitoring committee, clinical events committee)
• Collaborate with internal and external partners to ensure translation of the clinical protocol into operational deliverables, serve as primary contact for protocol guidance, provide training to the clinical execution team

Senior Clinical Scientist

• Contribute to the development and creation of clinical trial protocols following high scientific and clinical standards and applicable regulations
• Contribute to the identification, formulation and implementation of amendments to the clinical protocol, in close collaboration with clinical lead
• Contribute to the creation of study-level documents, including preparation of clinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updates and submission dossiers
• Contribute to the review and writing of clinical trial documents for CTR activities, and publications (as applicable)
• Support pharmacovigilance activities (e.g. contributing to creation and review of aggregate reports, patient narratives and attendance of pharmacovigilance monitoring meetings)
• Support regulatory activities (preparation of meetings with regulatory agencies)
• Produce training materials, share best practices and provide training to the broader clinical trial teams
• Support preparation and (if applicable) participate in study level meetings (i.e. - Investigator Meetings, Data Monitoring meetings, and others)
• Support and guide the development of data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study (across countries/ sites)
• Includes support for Case Report Form (CRF) development, and implementation of data capture tools
• Deep expertise to perform in depth and high-quality clinical data review, to identify clinical data insights through ongoing patient level review and trends analysis to support Interim Analysis, Database and Post Lock activities and resolution of scientific & medical issues throughout the study lifecycle
• Work to improve the quality of reviews and insights with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review
• Provide insights to and facilitate data review process improvements by identification of redundant reports, implementation of innovative data analysis processes and tools, and their continuous improvement
• For all these tasks, work in close collaboration and alignment with clinical development lead
• Ensure all questions / issues requiring medical oversight are brought to the attention of the clinical development lead

• publish content on external website (dcri.org) and intranet (Pulse) using content management systems (Drupal and SharePoint, respectively)
• create graphics for social media, external websites, and intranet
• determine requirements for instructional audiovisual media and coordinate production of slide series, films, videotapes and other media materials for use
• works both independently and collaboratively with internal Shared Services department, Production Designers and Marketing Managers on a wide mix of creative initiatives
• manage calendar of DCRI’s scientific conferences, researching Duke-related presentations at each show
• for scientific conferences at which DCRI has an exhibit booth, coordinate the marketing collateral needed for the booth
• prepares layouts, designs, artwork and formats for use in publication and/or exhibition design
• contribute to editorial planning by suggesting content ideas, target channels and audiences, and appropriate project timelines
• compile weekly internal newsletter in MS Outlook
• create quarterly external-facing newsletters using Constant Contact
• occasional content development for DCRI-owned external and internal channels
• serve as backup manager of DCRI’s social media channels (Twitter and LinkedIn)
• assist in the shooting and production of video and audio projects
• develop a broad knowledge of research conducted at the DCRI

Clinical Research Comm Specialist III

• Manage and oversee local trial management services throughout the study
• Execution of local milestones from feasibility through study close out
• Resourcing of country-level roles in collaboration and agreement with the study Functional Manager (FM)
• Close collaboration with assigned Local Trial Manager(s), Lead Site Manager, Site Managers, Clinical Trial Associates, and Site Contract Managers
• Inspecting Readiness and AQR at the country level
• Country level ad hoc meetings to address unexpected circumstances that might impact country or study level deliverables
• Provide updates, discuss hurdles, timelines/resources, and potential risks with the study FM
• Assist with necessary documentation for leadership

Clinical Trial Manager

• Works independently or with minimal supervision to oversee the day-to-day activities of a clinical trial in accordance with Good Clinical Research Practice (GCP)
• Runs portions of clinical trials from startup to closeout, including protocol coordination (screening, recruiting, enrolling, consenting), feasibility planning, data management, biological specimen management, preparation for monitoring visits, and regulatory and/or IRB document preparation
• Ensures all study procedures are conducted according to the protocol and applicable regulations
• Assists with the orientation and training of new staff
• Maintains accurate subject log, tracks expense, submits appropriate documentation to Grant Administrator on a monthly basis for payment due for visits on all studies
• Organizes and maintains documentation of all patient data

Senior Clinical Research Coordinator

• Manage studies to provide safety and efficacy data for regulatory approval of drugs
• Ensure high-quality clinical trials integrating state-of-the-art technology and rigorous ethical standards
• Primary responsibility for planning and directing clinical research activities in Thoracic Oncology
• Manage the entire cycle of clinical development including strategy, study design, execution, monitoring, analysis, and reporting
• Provide scientific leadership and collaborate with cross-functional teams
• Interact externally with key opinion leaders and maintain awareness of scientific developments

Distinguished Scientist, Clinical Research, Thoracic Malignancies

• responsible for the planning and directing of clinical research activities involving new or marketed medicines in the Oncology therapeutic area, Hematology section
• manage and oversee the entire cycle of late-stage clinical development from Phase 2 to Phase 5
• lead cross-functional product development teams that oversee program strategy and execution
• provide internal scientific leadership for cross-functional areas supporting clinical trials
• interact externally with key scientific leaders
• evaluate pre-clinical and translational work for the purpose of generating early clinical development plans and Investigational New Drug (IND) applications
• develop clinical development strategies for investigational or marketed medicines
• monitor and manage the conduct of ongoing or new clinical trials for investigational or marketed medicines
• act as an integration of cross-functional input and expertise
• analyze and summarize the clinical findings from studies to support decisions regarding safety and efficacy

Executive Director, Product Development Team Leader, Clinical Research – Hematology, Lymphoma

• Oversees the execution and regulatory compliance of clinical studies
• Conducts and oversees all aspects of clinical studies, ensuring strict compliance with regulatory standards (ISO, GCP, FDA) and Philips procedures
• Optimizes study efficiency and data quality through process improvements
• Collaborates with Clinical, Medical, Biostatistics, Data Management, Regulatory, Quality, R&D, and other internal teams
• Monitors study progress against milestones, timelines, and budgets; proactively identifies risks and resolves issues

Clinical Study Manager

• planning and directing of clinical research activities involving new or marketed Oncology medicines
• manage the entire cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication
• evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications
• developing of clinical development strategies for investigational or marketed Oncology drugs
• planning clinical trials (design, operational plans, settings) based on these clinical development strategies
• monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Oncology drugs
• analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication
• participating in internal and joint internal/external research project teams relevant to the development of new compounds and the further study of marketed compounds

Senior Principal Scientist, Clinical Research, GI

• Provide strategic HCC leadership, oversight and execution of the G lobal Health Care Compliance program for R& D, Clinical Research, Medical Affairs, and related activities.
• Act as a compliance partner and trusted advisor to G lobal R&D, Clinical Research and Medical Affairs teams, providing timely , practical guidance on clinical trials, investigator and site interactions, advisory boards, and scientific exchange.
• Assist in identifying , assessing, and mitigating compliance risks associated with clinical research activities and medical engagement models.
• Support compliance risk assessments, issue management, and monitoring activities related to R&D, Clinical Research and Medical Affairs.
• Collaborate with Legal, Privacy, Quality, Finance, and other assurance functions to deliver coordinated compliance support and risk mitigation.
• Contribute to the development, implementation, and maintenance of policies, procedures, and training materials related to R&D, Clinical Research and Medical Affairs compliance.
• Support responses to internal inquiries, audits, monitoring activities, and regulatory requests related to clinical and medical compliance topics.

Clinical Research Manager, Medical Affairs

• Overseeing the administrative responsibilities and project management of TELA Bio’s clinical operations activities
• Supporting the execution of company sponsored studies, investigator-initiated activities, and day-to-day clinical operation tasks
• Support the set-up and have operational responsibility for the maintenance of the local electronic Trial Master File (eTMF) including document tracking in accordance with ICH-GCP and local requirements
• Collaborate with Clinical Project Managers (CPM) during the document collection process
• Maintain study documents ensuring template and version compliance
• Ensure important documents under their responsibility are of quality and uploaded in a timely manner
• Liaison/collaborate with Clinical Project Manager, Investigational Sites, Legal and Compliance to expedite and finalize contracts and amendments
• Create, prepare, and deliver reports to various departments
• Organize meetings and meeting schedules
• Perform clerical duties, such as filing, faxing, answering phone calls, and responding to emails

Clinical Research Coordinator

• Work in collaboration with Research Team Leaders and Principal Investigators with initiating study procedures for new IITs and industry-sponsored clinical trials
• Manage all aspects of Phase I – IV clinical trials
• Work directly with physicians to design, set-up and execute clinical trials
• Assist in analyzing data to determine response and clinical outcomes
• Develop and maintain ongoing communication with the clinical teams including laboratory, infusion, radiology, and others
• Care for participants in all age groups from young adult through geriatrics
• Administer or provide oversight of administration of medications and treatment agents
• Maintain clinical trial databases and update study records in real-time
• Provide coverage and support to other research nurses and coordinators to meet departmental/organizational staffing needs

Clinical Research Nurse – C/D

• Work in collaboration with Research Team Leaders and Principal Investigators with initiating study procedures for new IITs and industry-sponsored clinical trials
• Manage all aspects of Phase I – IV clinical trials
• Participate in the conduct of audits by study sponsors, CROs, the FDA, the Eastern Oncology Group, the University of Pennsylvania’s CTSRMC, and other groups
• Work directly with physicians to design, set-up and execute clinical trials
• Assist in analyzing data to determine response and clinical outcomes
• Provide ongoing service education updates to all investigators and HUP staff that have eligible participants for clinical research trials
• Care for participants in all age groups from young adult through geriatrics
• Establishes nursing plan of care in collaboration with the PI and study team and in accordance with research guidelines and GCP.

Clinical Research Nurse C/D

• Assist with manuscript preparation and submission.
• Organize and review study data.
• Draft and edit manuscript content.
• Coordinate revisions with investigators and ensure accuracy.

Clinical Research jobs in Pennsylvania

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Principal Scientist, Clinical Pharmacology – Pharmacometrics

Clinical/Medical Scientist – Oncology – Gynecologic Malignancies

Clinical Scientist, Manager – Translational Science and Medicine, Immunology

Clinical Scientist – Manager, Translational Science and Medicine – Immunology

Principal Scientist, Clinical Research

Principal Scientist, Biostatistics – Clinical Safety Statistics

Senior Clinical Scientist

Senior Clinical Scientist

Clinical Research Comm Specialist III

Clinical Trial Manager

Senior Clinical Research Coordinator

Distinguished Scientist, Clinical Research, Thoracic Malignancies

Executive Director, Product Development Team Leader, Clinical Research – Hematology, Lymphoma

Clinical Study Manager

Senior Principal Scientist, Clinical Research, GI

Clinical Research Manager, Medical Affairs

Clinical Research Coordinator

Clinical Research Nurse – C/D

Clinical Research Nurse C/D

Temporary Clinical Research Coordinator