Clinical Research

• 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.

• Oversee clinical trials, ensuring successful execution from start-up to close-out.
• Lead site selection and feasibility assessments, working closely with CRAs and investigators.
• Manage study timelines, budgets, and deliverables, ensuring adherence to project objectives.
• Provide oversight on protocol administration, site initiation, monitoring, and study progress.
• Collaborate cross-functionally with internal and external stakeholders, including sponsors, investigators, and project teams.
• Ensure compliance with GCP, FDA regulations, and company SOPs.
• Train and mentor CRAs and site staff, ensuring protocol adherence and data integrity.

Clinical Lead – Clinical Trial Manager, Renal

• Provides leadership in the planning, design, and execution of clinical studies sponsored by Penumbra to assess safety and effectiveness of products.
• Works with confidential subject and company data, and interfaces with a variety of internal and external stakeholders.
• Develops/maintains project timeline inclusive of startup through completion.
• Drives development, approval, and distribution of study-related documents and study tools for investigational sites and review committees.
• Manages distribution, collection and tracking of regulatory documentation to help ensure audit readiness.
• Negotiates study budgets with sites, Core Labs, and other vendors.
• Attends site visits as necessary.
• Contributes to process improvements that help foster continuous improvement.
• Helps update and maintain study trackers and dashboards.
• Participates in system user acceptance testing.
• Manages vendors such as Core Lab.
• Organizes and manages Investigator Meetings.
• Works with data management to develop systems for and track project metrics.
• Drives development, approval, and distribution of study-related documents including Case Report Forms and study manuals.
• Monitors progress of studies, identifies study-related trends/issues and implements corrective actions when necessary.
• Represents the Clinical Affairs Department on cross-functional meetings and projects as needed.

Clinical Study Manager

• Lead efforts in resolving day to day work related issues and problems, securing quality, improving efficiency and productivity of statistical and programming operations
• Provide statistical expertise for design, analysis and reporting of clinical trials and research projects
• Develop and/or review ADaM dataset specifications
• Perform statistical analysis as per SAP, and address peer/QC review comments and findings
• Provide statistical input to Case Report Forms (CRF) design and database/variable structure

Senior Biostatistician

• Provides leadership for the conduct of clinical studies and for the regulatory affairs function as it applies to product approval
• Develops and implements regulatory strategies to obtain timely product approvals from worldwide regulatory bodies
• Ensures regulatory submissions are accurately prepared and comply with regulatory approvals
• Represents Medtronic from a clinical research perspective within the country / region and also collects feedback from local customers and authorities
• Builds and maintains a strong network and close relationship with the various internal and external parties
• Leads execution for both local and global studies, manages clinical research projects over all of the Medtronic therapies across multiple businesses

Senior Clinical Research Director – CRDN

• Serve as clinical science lead and core member of clinical development team for one or more respiratory studies (asthma and/or COPD)
• Support day-to-day study execution, ensuring alignment with protocol, timelines, and regulatory requirements
• Act as a key scientific contributor to late-stage protocols and regulatory submissions; design and develop clinical trial protocols and associated documents (e.g. clinical study plans, data review plans, case report forms (CRFs), database design, statistical analysis plans) in collaboration with the clinical development leader
• Participate in medical monitoring activities: review and interpret clinical data on an ongoing basis in collaboration with cross-functional colleagues and external partners to ensure data quality, participant safety, and protocol compliance
• Participate in site selection, initiation, and ongoing engagement; provide scientific support to investigators and address protocol-related inquiries
• Serve as a core member of the clinical operations study delivery team, contributing to trial execution and oversight: track study progress against milestones and identify risks to timelines or data integrity, propose and help implement mitigation strategies, and serve as key scientific contact for CROs and vendors.
• Collaborate with Clinical Operations, Regulatory, Biostatistics, Data Management, and Safety teams to ensure alignment and trial execution
• Contribute to internal governance meetings (presenting or preparing study updates, data summaries, and key risks/issues)
• Ensure inspection readiness (maintain high-quality documentation and support audit/inspection activities)
• Support development and execution of publication plans, abstracts, and manuscripts
• Contribute to TPPs, clinical development plans, and risk-benefit assessments
• Support medical monitor with management of oversight committees for late-stage asthma studies (e.g., DSMB, Endpoint Adjudication Committee)

Director, Clinical Scientist – Respiratory Indications

• Conduct and coordinate all aspects of clinical trial activities at the site.
• Perform phlebotomy on patients, following proper clinical and safety protocols.
• Recruit, screen, and enroll study participants according to inclusion/exclusion criteria.
• Schedule and conduct study visits, ensuring adherence to protocol requirements.
• Accurately collect, process, and ship biological samples per study-specific guidelines.
• Complete and maintain study documentation, including source documents, regulatory binders, and informed consent forms.
• Perform timely and accurate data entry into electronic data capture systems (EDC).
• Communicate effectively with sponsors, monitors, and other research team members.
• Ensure compliance with GCP, ICH, FDA, and IRB regulations.
• Assist in monitoring visits and audit preparation as needed.

Clinical Research Coordinator, CRC

• Develop and manage study timelines, budgets, and resource plans
• Coordinate with internal stakeholders (e.g., product, regulatory, marketing, data) to align study objectives with business goals
• Proactively identify risks and implement mitigation strategies
• Author core clinical study documents, including protocols, informed consent forms (ICFs), and case report forms (CRFs)
• Lead full study lifecycle execution from startup through closeout.
• Prepare and manage IRB submissions, amendments, and continuing reviews
• Ensure studies are conducted in compliance with GCP and applicable regulatory and ethical guidelines
• Design and oversee clinical data systems, including EDC and eTMF

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Clinical Research Coordinator A, Community Canvasser

Clinical Research Coordinator A, Community Canvasser

Clinical Lead – Clinical Trial Manager, Renal

Clinical Study Manager

Senior Biostatistician

Senior Clinical Research Director – CRDN

Director, Clinical Scientist – Respiratory Indications

Clinical Research Coordinator, CRC

Senior Clinical Research Manager

Clinical Research Coordinator