Clinical Research

• 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.

Temporary Clinical Research Coordinator

• Managing and directing clinical research activities involving new or marketed drugs in the Oncology Clinical Research group and in the field of Thoracic Oncology.
• Managing the entire cycle of clinical development, including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meetings.
• Provide internal scientific leadership for cross-functional areas supporting clinical trials and interact externally with key opinion leaders.
• Evaluating pre-clinical and translational work for generating early clinical development plans and Investigational New Drug applications.
• Developing clinical development strategies for investigational or marketed agents that incorporate the latest scientific developments, regulatory requirements, competitive landscape, and commercial considerations.
• Planning clinical trials based on these strategies.
• Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed agents.
• Analyzing and summarizing clinical findings to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publications.
• Participation in internal and joint research project teams relevant to the development of new compounds and the further study of marketed compounds.

Distinguished Scientist, Clinical Research, Thoracic Malignancies

• Strong ability to apply statistics in the analysis of clinical trials
• Independent leadership of the design, analysis and reporting of at least 1 complex or multiple less complex studies/projects within the Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia
• Demonstrated ability to provide sound strategic and statistical input on study/research design to meet project needs, regulatory and scientific requirements
• Demonstrated ability in presenting results and defending statistical findings, study design and analysis.
• Excellent oral and written English communication skills
• Authored a protocol, DRT/DMC charter, SAP, CSR, or Research Project Plan (RPP)
• Strong knowledge of current CDISC standards for ADaMs

Lead Biostatistician

• Senior Local Operations Manager handling site aligned E2E partner communication across stakeholders throughout trial lifecycles
• Serve as the primary communication point for sites, facilitating client teamwork for issue resolution
• Ensure consistent conduct of site qualification visits and appropriate follow-up of site qualification visit report and country feasibility report
• Collaborate with central study team and local stakeholders for final selection of sites
• Meet recruitment targets with high quality data on time and within study budget
• Act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff throughout the trial
• Drive study compliance by maintaining and updating trial management systems
• Contribute to site level recruitment strategy and contingency planning
• Deliver competent vendor management at the country level to support the study
• Ensure high standards for study monitoring by conducting quality local trial team meetings

Clinical Trial Manager II

• Conduct grassroots, door-to-door, and other community-based outreach in Philadelphia
• Engage residents in research partnership with Penn to study health disparities
• Educate community members about importance of research participation
• Describe study and obtain informed consent from eligible participants
• Provide information on educational opportunities and resources
• Assist with data collection from study participants via home visits
• Collect data and maintain canvassing records
• Participate in basic training and regular research team meetings
• Support and interact with PIs, co-Is, research managers, and research staff
• Adhere to University guidelines and perform other assigned duties

Clinical Research Coordinator A, Community Canvasser

• Conduct grassroots, door-to-door, and other community-based outreach in North, West, South, and Southwest Philadelphia to engage residents in a research partnership with Penn to study the causes of racial and ethnic health disparities related to eczema.
• Provide education on the importance of research participation and increase access to research opportunities.
• Describe the study and obtain informed consent from eligible participants.
• Provide information on educational opportunities and other resources for information about and care for eczema.
• Assist with data collection from study participants via home visits.
• Maintain canvassing records.
• Participate in basic training on eczema and research procedures.
• Participate in regular research team meetings.
• Support and interact with PIs, co-Is, research managers, and other research staff.
• Maintain all relevant trainings and certifications (CITI, GCP, PENN CRC certification and assigned Penn Profiler trainings).
• Adhere to all University of Pennsylvania, GCP, and FDA guidelines.
• Perform other duties as assigned which may include assisting with the collection, processing, and shipping of human specimens and/or environmental samples.
• Position involves work-related responsibilities that may occur outside of the usual workday times (before 8am or after 5pm) and during weekend days.

• Planning clinical trials (design, operational plans) based on the clinical development strategies for investigational or marketed infectious disease drugs
• Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed infectious disease 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 publications
• Participation in internal and joint internal/external research project teams relevant to the development of investigational drugs, and the further study of marketed drugs
• Developing clinical development strategies for investigational or marketed infectious disease drugs

Senior Director, Clinical Research

• The Executive Director will manage and oversee the entire cycle of late-stage clinical development from Phase 2 to Phase 5, including development of program strategy and design, protocol authoring, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meetings.
• They will lead cross-functional product development teams that oversee program strategy and execution, will provide internal scientific leadership for cross-functional areas supporting clinical trials, and will interact externally with key scientific leaders.
• Evaluating pre-clinical and translational work for the purpose of generating early clinical development plans and Investigational New Drug (IND) applications.
• Developing clinical development strategies for investigational or marketed medicines that incorporate the latest scientific developments, regulatory requirements, the competitive landscape, and commercial considerations.
• Executing the clinical strategy, planning clinical trials (design, operational plans, settings), and leading the clinical subteam.
• Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed medicines.
• Leading cross-functional product development teams that oversee overall strategy and execution for investigational or marketed medicines.
• 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 publications.
• Participation in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds.

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

• Planning and directing clinical research activities involving new or marketed Neuroscience Medicines.
• Managing the entire cycle of clinical development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meetings.
• Providing internal scientific leadership for cross-functional areas supporting clinical trials.
• Interacting externally with key opinion leaders.
• Evaluating pre-clinical and translational work for the purpose of generating early clinical development plans and Investigational New Drug applications.
• Developing clinical development strategies for investigational or marketed Neuroscience drugs.
• Planning clinical trials based on these clinical development strategies.
• Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Neuroscience drugs.
• Analyzing and summarizing clinical findings to support decisions regarding safety and efficacy, as well as new drug applications and clinical study reports.

Senior Principal Scientist, Clinical Research, Neuroscience

• The Senior LTM role will be accountable/responsible for ensuring top-quality end-to-end trial delivery at a country level, managing the consistency of Local Trial Management duties and processes.
• The Senior LTM will serve as the country-level single point of contact on the study for internal partners.
• They are site aligned E2E partner to streamline communication across cross functional stakeholders throughout trial lifecycles.
• Serves as the primary point of communication for sites, facilitating internal client teaming to drive issue resolution.
• Intimately understands site operational model and owns relationships with critical site stakeholders to provide a voice for the site to the client's teams.
• Principal Local Operations Manager: trial aligned member of CFTT for USA-level accountability, serves as “quarterback” for Local Operations Managers and representing a single voice to the global team.
• The Sr LTM will manage and oversee the following throughout the study: Central IRB and other local vendors.
• Execution of local milestones from feasibility through study close out.
• Resourcing of country-level roles, including support with transitions, in collaboration and agreement with the study Functional Manager (FM).
• Inspection Readiness and AQR at the country level.
• Close collaboration with the assigned Local Trial Manager(s) (LTMs), Lead Site Manager (LSM), Site Managers (SMs), Clinical Trial Associates (CTAs), and Site Contract Managers (SCMs) to outline accountabilities/responsibilities and provide support and training, where necessary.
• Efficient communication with the Clinical Trial Managers (CTMs), Clinical Operations and the Global Trial Leader (GTL) to oversee trial excellence.
• Country level ad hoc meetings during any phase of the study that are needed to address unexpected circumstances that might impact country or study level deliverables.
• Close partnership with the study FM to provide updates, discuss hurdles, timelines/resources, and potential risks, and assist with documentation that may be required by leadership.
• Autonomy with execution of local trial management services.
• Depth of knowledge with local trial management services.

Senior Clinical Trial Manager

• Planning and executing clinical-trial biomarkers across the pipeline
• Ensuring compliant, efficient biospecimen collection, assay execution, and data delivery
• Driving operational excellence, data quality, and compliance across the biomarker assay project lifecycle
• Partnering closely with scientific and operational colleagues to support a cohesive and agile team that delivers high-quality biomarker data for clinical trials and translational research
• Collaborating closely with biomarker scientists and study teams to plan clinical-trial biomarker set-up and logistics
• Serving as the operational partner to Biomarker Leads, helping implement strategies that advance biomarker programs
• Co-authoring biomarker-related sections of clinical study protocols
• Collaborating with Translational Molecular Biomarker Scientists to define and manage specimen collection, handling, shipping, storage, and processing requirements
• Developing biomarker vendor statements of work and data-transfer specifications in partnership with clinical teams
• Working with clinical teams to coordinate sample and assay logistics, issue resolution and risk mitigation
• Partnering with Data Management to transfer biomarker data from external vendors into the clinical data repository
• Designing sample collection kits, laboratory manuals, and specimen logistics for shipments to third-party vendors
• Building and maintaining effective partnerships with external biomarker vendors and internal teams
• Proactively identifying and resolving conflicting stakeholders needs to maintain alignment and momentum
• Implementing and continuously improving streamlined workflows that maximize efficiency and data quality

Senior Scientist, Clinical Research – Biomarker Operations

• primary responsibility for planning and directing clinical research activities
• managing the entire cycle of clinical development including study design, placement, monitoring, analysis, regulatory reporting, and publication
• evaluating pre-clinical and translational work to generate early clinical development plan
• developing clinical development strategies for investigational or marketed Oncology drugs
• planning clinical trials and monitoring the conduct of ongoing or new clinical trials
• analyzing and summarizing clinical findings to support decisions regarding safety and efficacy
• supervising activities of Clinical Scientists
• collaborating with a cross-functional group of experts

Senior Principal Scientist, Clinical Research, Lymphoma

• Coordinate and implement research projects focused on gastrointestinal diseases.
• This position is hybrid eligible, however, requires implementation of in-person study visits at least 4 days a week during most weeks.
• Screening, recruiting, and consenting patients according to protocol.
• Chart review to confirm eligibility.
• Scheduling and conducting patient study visits.
• Collecting study data, completing case report forms, entering data into study databases and resolving data entry errors/queries.
• Communicating with study team members and patients.
• Collecting and processing (if needed) study specimens.
• Participating in study team meetings.
• Showing vigilance in patient safety, protocol compliance, and data integrity.
• Adhering to all University of Pennsylvania and GCP guidelines.
• Establish workflows and methods to operationalize protocols, regularly prepare, draft, and submit regulatory correspondences, and mentor/train less experienced research staff in the completion of their duties when required (for CRC B).

Clinical Research Coordinator A/B, Epidemiology Division

• Assist in the coordination of multiple research projects focused on gastrointestinal disorders
• Screening of patients, obtaining informed consent
• Collection, processing, and storage of biological samples
• Collection and entry of patient-reported data and clinical information
• Collaborate with the research team to accomplish study goals
• Establish workflows and methods to operationalize protocols (for CRC-B)
• Mentor/train less experienced research staff (for CRC-B)

• Assist with study coordination and biospecimen management for breast cancer studies
• Assess eligibility of subjects, schedule appointments, and conduct reminder communications
• Manage biospecimen collection, logging, and shipping
• Support patient communications for clinical trials
• Conduct data entry and maintain participant charts

Clinical Research Assistant A/B, Hematology/Oncology

• The Senior LTM role will be accountable/responsible for ensuring top-quality end-to-end trial delivery at a country level.
• Managing the consistency of Local Trial Management duties and processes.
• The Senior LTM will serve as the country-level single point of contact on the study for internal partners.
• While the Sr LTM may delegate tasks to other LTMs or roles on the study, the Sr LTM remains accountable for successful completion of those tasks.
• The Sr LTM will manage and oversee the following throughout the study: Central IRB and other local vendors, including set up of vendor purchase orders, invoice review and approval, and change-orders, as applicable.
• Execution of local milestones from feasibility through study close out.
• Resourcing of country-level roles, including support with transitions, in collaboration and agreement with the study Functional Manager (FM).
• Inspection Readiness and AQR at the country level.
• Close collaboration with the assigned Local Trial Manager(s), Lead Site Manager, Site Managers, Clinical Trial Associates, and Site Contract Managers to outline accountabilities/responsibilities and provide support and training, where necessary.
• Efficient communication with the Clinical Trial Managers, Clinical Operations and the Global Trial Leader to oversee trial excellence.
• Country level ad hoc meetings during any phase of the study that are needed to address unexpected circumstances that might impact country or study level deliverables.
• Close partnership with the study FM to provide updates, discuss hurdles, timelines/resources, and potential risks, and assist with documentation, such as storyboards, lessons-learned, metrics, etc., that may be required by leadership.
• Autonomy with execution of local trial management services.
• Depth of knowledge with local trial management services.
• Process leadership.

See all jobs on JobTailor

Clinical Research Manager, Medical Affairs

Clinical Research Coordinator

Clinical Research Nurse – C/D

Clinical Research Nurse C/D

Temporary Clinical Research Coordinator

Distinguished Scientist, Clinical Research, Thoracic Malignancies

Lead Biostatistician

Clinical Trial Manager II

Clinical Research Coordinator A, Community Canvasser

Clinical Research Coordinator A, Community Canvasser

Senior Director, Clinical Research

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

Senior Principal Scientist, Clinical Research, Neuroscience

Senior Clinical Trial Manager

Senior Scientist, Clinical Research – Biomarker Operations

Senior Principal Scientist, Clinical Research, Lymphoma

Clinical Research Coordinator A/B, Epidemiology Division

Clinical Research Coordinator A/B, Epidemiology Division

Clinical Research Assistant A/B, Hematology/Oncology

Clinical Trial Manager II