Clinical Trial Research Monitor II Temple University Health SystemClinical Trial Research Monitor IIPhiladelphia, PAThe OCR Clinical Research Monitor II, completes, revises and reviews the requirements necessary to attaining and maintaining compliance with the FDA and other regulatory bodies for clinical trial research both from a documentation and process level. Other applicable certification, related training, or education programs may be considered in lieu of those listed below (i.e. Regulatory Affairs).
Clinical Research Coord (Temple Health-Main Campus) Temple University Health SystemClinical Research Coord (Temple Health-Main Campus)Philadelphia, PAIn addition, this position is expected to interact with the institutional investigators, other members of the healthcare team, service line members and research participants/families in a manner, which supports the conduct of clinical trials. Provides leadership in the management and operation of clinical research protocols to ensure research participant recruitment and accrual, protocol compliance, research participant safety and data quality.
Clinical Research Coordinator Integrated Resources, IncClinical Research CoordinatorMalvern, PennsylvaniaFull timeClient provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer's disease, epilepsy, migraine prevention and treatment), pain management, and women's health. The Temperature Management Coordinator is responsible for day to day the execution management of the Temperature Management & Control for Clinical Supplies clinical supplies during the execution phase of clinical trials consistent with GMP guidelines with a specific focus on Temperature Management & Control of Clinical Supplies.
Clinical Research Budget, Financial Analyst - Fox Chase Cancer Center Temple University Health SystemClinical Research Budget, Financial Analyst - Fox Chase Cancer CenterPhiladelphia, PAThis includes the development of clinical research budgets (from start to finish); budget amendments; budget negotiations; creating reports; reviewing clinical trial agreements; scientific protocol, and maintaining fee schedule updates. Responsible for financial and accounting processes and deliverables related to clinical research activities invoicing & large data sets.
Principal Scientist, Clinical Research - Immunology/Dermatology Merck & Co IncPrincipal Scientist, Clinical Research - Immunology/DermatologyNorth Wales, PA$255,800–$402,700 / yearAssist the Senior Director, Associate Vice-President/Vice-President and Product Development Team Lead in ensuring that appropriate corporate personnel is informed of the progress of studies of our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to their areas of responsibility. With a focus on late-stage development, the Clinical Director will manage the entire cycle of clinical development, including determination of appropriate disease indications to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.
Clinical Trial Manager Avalo TherapeuticsClinical Trial ManagerChesterbrook, PAAny resumes submitted without an agreement and/or any resumes sent unsolicited through e-mail accounts of Avalo employees will be considered outside of the appropriate process, do not imply or create any obligation on our part, do not impart any restrictions on Avalo with respect to the hiring of any persons whose resumes are so submitted and are not eligible for placement fees. Avalo is advancing its lead anti-IL-1 monoclonal antibody (mAb) drug candidate, abdakibart, into a phase 3 registrational program in hidradenitis suppurativa (HS), a chronic inflammatory skin condition that affects an estimated 1–4% of the population globally.
Clinical Research Systems Director - JCRI Thomas Jefferson UniversityClinical Research Systems Director - JCRIPhiladelphia, PAJefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Thomas Jefferson University, home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200+ undergraduate and graduate programs to more than 8,300 students.
NewClinical Research Assistant Children's Hospital of PhiladelphiaClinical Research AssistantPhiladelphia, PA$21.05–$26.35 / hourSpecific responsibilities include: 1) assisting in the day today administration of research projects; 2) maintaining subject tracking system and scheduling subjects for assessments; 3) conducting follow-up phone evaluations with families; 4) organizing and overseeing data entry; and. The clinical research assistant will work on projects that examine the effectiveness of suicide prevention interventions and treatment in the ED settings, including the CHOP Emergency Department and the Crisis Response Center (CRC); as well as the CHOP in-patient units in Cedar Ave.
Clinical Research Nurse II Temple HealthClinical Research Nurse IIPhiladelphia, PATemple Health consists of Temple University Hospital (TUH), Fox Chase Cancer Center, TUH-Jeanes Campus, TUH-Episcopal Campus, TUH-Northeastern Campus, Temple Physicians, Inc., and Temple Transport Team. In addition, this position is expected to interact with the institutional investigators, other members of healthcare team, service line members and research participants/families in a manner, which supports the conduct of clinical trials.
NewClinical Trial Manager Ocugen IncClinical Trial ManagerMalvern, PAThis includes leading the cross-functional study team, managing vendor and site performance, maintaining budget and timelines, and ensuring high-quality data and regulatory compliance. Serve as the primary point of contact for study vendors (e.g., CROs, central labs, IRT, eCOA) and oversee vendor selection, scope development, contracting, and performance management.
Clinical Research Assistant B University of PennsylvaniaClinical Research Assistant BPhiladelphia, PA$19.47–$19.81 / hourLong-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn's distinctive interdisciplinary approach to scholarship and learning.
Clinical Outsourcing Lead Integrated Resources, IncClinical Outsourcing LeadCollegeville, PennsylvaniaFull timeJob DescriptionTechnical Skill RequirementsFinance / clinical budgetingDemonstrates clear understanding of activity based costs along study path; additionally, Director Level (P05) demonstrates expertise in strategic cost relationships and links (program, asset, portfolio, etc.) for planning and forecasting, negotiation, and higher level presentationUnderstands components of clinical & per subject costing & use of industry benchmarkingOperational expertise in study scheduling and placementKnowledge of clinical study outsourcing; Director Level (P05) requires expert knowledge in clinical trial development outsourcingUnderstanding of operational impact to timelines, budget, and quality desired, and required for Director Level (P05)Negotiating and contracting skillsKnowledge and experience of contracting with external service providersApplication of contracting strategies at enterprise levelsInternal and external influencing abilities for expectation and timeline management; for Director Level (P05), proven experience requiredIdentifies and leads efforts to examine multiple solutions or innovative options in solving highly complex problems directly impacting a Global Business Unit/Global Operating Unit or Sub Business Unit/Sub Operating UnitQualificationsQualificationsBA or BS degree and/or recognized amount of work experience (preferably in a related discipline).An advanced degree (MBA, JD, etc.), prior management responsibilities, and/or substantial work experience is preferential for the Director Level (P05).Clinical trials Sponsor experience, CRO operational and/or BD experience, or other trial related experience, including significant experience negotiating and drafting clinical trial-related agreements is required. Excellent oral/written communication skills and proficiency with MS Office applications (Word/PPT/Excel) required: experience with ACW, ClearTrial, Grants Manager and / or other industry cost and planning tools preferred.
Project Manager B: Protocol Development, Clinical Statistics and Data Analyses University of PennsylvaniaProject Manager B: Protocol Development, Clinical Statistics and Data AnalysesPhiladelphia, PA$66,000–$81,441 / yearDevelop on-line clinical trial management data bases to monitor and analyze clinical trial study requirements and dataanalysesStudy Start-up for Investigator Initiated Studies· Independently prepare and negotiate clinical trials budgets with external sponsors· Conduct study qualification visits for multi-site studies· Conduct study initiation visits for all sites (including UPHS facilities)· Develop detailed data transfer specifications for acquiring external data transfer from participating sitesStudy Monitoring/Compliance for Investigator Initiated Studies· Responsible for ensuring timely and accurate completion of Serious Adverse Events (SAEs) and Adverse Events (AEs) atparticipating sites (UPHS and external locations)· Monitor participating sites for protocol compliance and deviations with reports to regulatory authorities as required· Issue and resolve queries from various data sources (medical coding, medical history, adverse events, procedures andmedical devices)Statistical and Study Related Analyses· Review of emerging clinical data and trends in cardiac surgery· Design complex surgical outcomes databases· Analyze complex surgical outcomes databases· Integrate database systems with statistics programs using SAS, Stata and other tools· Perform complex programming using large databases of more than 1 million records and nationwide hospital data sets foruse in health services research and quality analyses. + Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility.
RN-Clinical Research Nurse-Katz Temple UniversityRN-Clinical Research Nurse-KatzPhiladelphia, Pennsylvania$43.46–$59.40 / hourCoordinate recruitment and enrollment of research participants; * Establish and maintain databases of subjects; * Schedule and conduct study visits; * Collect and enter data; register subjects and study visits in OnCore; * Perform Epic research billing review; * Maintain an up-to-date regulatory binder; * Schedule and attend sponsor visits; and prepare and submit IRB paperwork to ensure compliance with IRB regulations. The Clinical Research Nurse-Pool, under the direction of the Director, CRORA and Clinical Investigators, will be responsible for the planning, implementation, and execution of Clinical Research studies in one or more departments in the Lewis Katz School of Medicine at Temple University.
Clinical Research Coordinator I - Rheumatology Children's Hospital of PhiladelphiaClinical Research Coordinator I - RheumatologyPhiladelphia, PA$53,000–$66,300 / yearThe clinical research coordinator will provide regulatory support for divisional Investigational Drug Application (IND) and Investigational Device Exemption (IDE) studies, day-to-day study management and facilitation of clinical trials, recruitment of patients into clinical research studies, and on-boarding support for team members. Ledby Clinical Research Director, Pamela Weiss, MD, MSCE, the Rheumatology Research Core is seeking an experienced Clinical Research Coordinator to work alongside a team of research support staff.
CLINICAL RESEARCH MONITOR Temple HealthCLINICAL RESEARCH MONITORPhiladelphia, PATemple Health consists of Temple University Hospital (TUH), Fox Chase Cancer Center, TUH-Jeanes Campus, TUH-Episcopal Campus, TUH-Northeastern Campus, Temple Physicians, Inc., and Temple Transport Team. To support this mission, Temple Health is continuously recruiting top talent to join its diverse, 10,000 strong workforce that fosters a healthy, safe and productive environment for its patients, visitors, students and colleagues alike.
NewClinical Research Coordinator II - Hematology Children's Hospital of PhiladelphiaClinical Research Coordinator II - HematologyPhiladelphia, PA$58,300–$72,900 / yearUnder minimal supervision, this role substantially coordinates all clinical research activities within the scope of clinical research protocols. Develop informed consent document and/or draft or edit IRB protocols or related documents such as study administration manuals.
Clinical Research Nurse C University of PennsylvaniaClinical Research Nurse CPhiladelphia, PACoordinate the conduct of Phase I - IV clinical trials including consenting, screening and enrolling eligible subjects, follow GCP guidelines in the conduct of trials, coordinate implementation of research protocols with study and clinical team, collecting and reporting research data, accessing and reporting AE/SAEs per protocol, managing subject treatment per protocol, oversight and coordination of research testing, including labs, office visits and radiology exams, coordinate subject care with clinical team, provide coverage and support to research coordinators. • Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility.
Clinical Research Coordinator B/C (Abramson Cancer Center) University of PennsylvaniaClinical Research Coordinator B/C (Abramson Cancer Center)Philadelphia, PA$53,418–$60,813 / yearTake a lead role in Site Feasibility and Qualification Visits; work in conjunction with the Unit Managers to initiate start-up processes for industry-sponsored and Investigator-initiated trials; independently manage the conduct of complex (i.e., multi-drug regimens, high toxicity potential, multiple random assignments, or immunotherapies, etc.) Phase I – IV clinical trials inclusive of managing multi-site projects where Penn is the lead site. Specific responsibilities include (but are not limited to): + Plan, organize, and contribute to study-related meetings, including but not limited to Investigator Meetings, Site Initiation Visits, Intermediate Monitoring Visits, Close-out Visits, Internal Audits, and ongoing training sessions; maintain complete and accurate records of meetings/sessions, and ensure that resulting action items are completed in a timely manner.
NewSenior Clinical Trial Manager Ocugen IncSenior Clinical Trial ManagerMalvern, PACTM leads complex or high-priority studies with minimal supervision, drives study start-up activities, and maintains strong engagement with investigators and study physicians. This role requires a hands-on, highly organized individual who is comfortable operating in a fast-changing, resource-constrained environment and who can drive execution through vendors, CROs, and internal teams.