Clinical Research Associate Jobs in Chester, PA

Site Name: USA - Pennsylvania - Upper Providence We are seeking a highly motivated and creative postdoc to join the Infectious Disease Research group in Upper Providence, Pennsylvania. In this lab-based role, you will be responsible for independently designing and executing laboratory experiments to evaluate the biology of Hepatitis B Virus (HBV). You will be expected to familiarize yourself with available data to generate hypotheses and closely collaborate with matrix partners to ensure experiment designs generate data that best support clinical-stage therapeutic programs. The ideal candidate will have a strong background in immunofluorescent imaging and analysis, extensive technical experience working with mammalian cell cultures and molecular biology assays, and the ability to work effectively in cross-functional teams Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: * Ph.D. in a relevant discipline, which includes molecular biology, cell biology or infectious disease. * A minimum of 1 years' experience with immunofluorescent staining and imaging protocols, including image analysis software and methodologies. * A minimum of 2 years' experience with mammalian cell culture and molecular biology & standard laboratory assays (e.g., qRT-PCR, ELISA, nucleic acid isolation, protein extraction, fluorescence in situ hybridization). * A minimum of 2 years' experience demonstrating testing of data-driven hypotheses * A minimum of 2 years' experience demonstrating diligent documentation of experimental results with strong attention to detail Preferred Qualifications: If you have the following characteristics, it would be a plus: * Laboratory research experience and expertise in virology, ideally in HBV. * Experience with plating and maintaining primary hepatocytes. * Experience with omics, single cell analyses, and/or systems biology. * Experience in translational research, including evaluating drug mechanisms of action and target engagement. * Ability to work effectively in cross-functional teams and build strong professional relationships. * Strong problem-solving skills, including the ability to proactively troubleshoot technical challenges. * Agile workstyle, with the ability to refine and focus experimental objectives to deliver high quality datasets in a timely manner. * Excellent written and verbal communication skills, with the ability to convey complex scientific information clearly and concisely. Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at ************** (US Toll Free) or *************** (outside US). GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at *********************************

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description RESPONSIBILITIES: • The Supporting Clinician will provide medical and scientific study and project support for multiple, global, Phase 1-4 clinical studies in a clinical program. • coordinating and leading the investigation process on all manufacturing and laboratory incidents related to all deviations including biomanufacturing process and equipment deviations and deviations for all analytical assays. • protocol and study training • Data review and interpretation • study and/or program scientific and integrity oversight • safety review and communication • regulatory document, study report and publication preparation and review • Independently write/design protocol outlines, protocols, and amendments of moderate complexity in collaboration with the Lead Clinician • Support the preparation of other clinical documents as required • DATA REVIEW AND INTERPRETATION: o Proactively coordinate with the Lead Clinician to assure understanding and agreement on deliverables o Responsible for review of patient level data across a study and coordinating with Lead Clinician for study level review as delegated o Study analysis and decision point preparation o Interprets data and is able to identify issues of moderate/difficult complexity o Conducts data review independently • STUDY MEDICAL OVERSIGHT: o Collaborates with the Lead Study Clinician(s) and COSTL to provide guidance during the execution of the study o Provide input into the monitoring plan • SAFETY: o Ensure timely communication of safety issues o Review and approval of subject narratives as delegated by the Lead Clinician • REGULATORY AND PUBLICATIONS: o Provide input, review and edit clinical study reports (CSR) o Provide full review of content and integrates information from literature and other sources as appropriate o Support and contribute to various sections of regulatory filings (Pediatric Investigational Plan, IB, IND/NDA Annual Reports, and PSURs and Regulatory authority responses) o Audit responses as delegated by the Lead Clinician • CLINICAL PROGRAM IMPLEMENTATION: o Ensure regulatory compliance and GCP adherence at the study level with regard to medical/scientific issues o Initiate and coordinate corrective action for major medical/safety/scientific study level issues o Along with Lead Study Clinician(s) and COSTL and with regard to medical/safety concerns, ensures study level issues are resolved o Collaborate with Lead Clinician and COSTL to arrive at major site level decisions based on input from the team o Coordinates with Lead Study Clinician(s) and COSTL to maintain study timelines o Along with the Lead Study Clinician(s) and COSTL and other study team members, participates in training of Study Management Staff and monitoring staff o In collaboration with the Lead Study Clinician(s) and COSTL and study team, ensures the clinical trial material requirements of the study are met o Ensure standard processes, tools, and procedures used consistently and globally o Participates in developing training strategy for study with the study team members Provide input into the preparation of study level training materials in collaboration with Lead Study Clinician(s) and COSTL and team members o Ensures appropriate filing of documentation in the trial master file Qualifications QUALIFICATIONS AND SKILLS NEEDED: • M.D., PhD, Pharm. D. Degree in science or health-related field preferred, will consider highly motivated and experienced MA or MS • 10+ years of pharmaceutical/CRO experience preferred TECHNICAL SKILLS: • Has extensive knowledge of the clinical research process and Good Clinical Practices from previous employment experience in the clinical research field • Has demonstrated ability and level of experience with integrating and summarizing medical/scientific concepts in protocols and other clinical documents • Has independently authored clinical study documents • Has experience with participating in and informally leading an operational team • Applies knowledge of internal/external business challenges to facilitate process improvements • Has ability to proactively resolve issues and work independently with minimal supervision • Has working knowledge of statistics, data analysis, and data interpretation • Has exceptional written and oral communication and cross-functional collaborative skills • Is proficient in MS Word, Excel, and PowerPoint

Senior CRA Responsibilities include: * All aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, writing of clinical trial reports, conduct of pre-study and initiation visits, liaise with vendors and other duties * All aspects of site and registry management as prescribed in the project plans * Organize and make presentations at Investigator Meetings * Report, write narratives and follow-up on serious adverse events * Review progress of projects and initiate appropriate actions to achieve target objectives * You may serve as lead monitor for a protocol or project and assist in establishing monitoring plans if required * Participate in the development of protocols and Case Report Forms as assigned * Interact with internal work groups to evaluate needs, resources and timelines Qualifications * 5+ years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and close-out visits) preferably in a CRO or Pharma environment * Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines * Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of Seas * Good knowledge of ICH Guidelines and GCP, monitoring procedures and understanding of the clinical trial process * Good planning, organization and problem solving abilities * Good communication and interpersonal skills Additional Information All your information will be kept confidential according to EEO guidelines.

About Us At Cooper University Health Care, our commitment to providing extraordinary health care begins with our team. Our extraordinary professionals are continuously discovering clinical innovations and enhanced access to the most up-to-date facilities, equipment, technologies and research protocols. We have a commitment to our employees to provide competitive rates and compensation programs. Cooper offers full and part-time employees a comprehensive benefits program, including health, dental, vision, life, disability, and retirement. We also provide attractive working conditions and opportunities for career growth through professional development. Discover why Cooper University Health Care is the employer of choice in South Jersey. Short Description • Plans, organizes, coordinates, directs and personally participates in major cancer research projects, including development and implementation of research protocols and grant proposals • Reviews and analyzes resulting research data, revises techniques or approaches to work problems as indicated as necessary by research data. • Compiles, writes and submits project results to principal investigator or Director of Surgical Research. • Assists Surgery/Oncology trainees in preparation of research papers, reports and abstracts for publication as one of co-authors, or one of the co-corresponding authors, or the corresponding author. • Designs, develops or adapts equipment used in experiments or research to obtain desired results. • Plans and supervises training of Surgery/Oncology trainees, technicians and other laboratory personnel with respect to proper laboratory techniques, use of laboratory equipment, and safety procedures. • Confers with industrial, governmental or other groups concerning progress or results of research project. • Supervises large group of employees engaged in performance of technical and professional work, which varies from routine to complex laboratory work tasks. • Applying for research grants from funding agencies is highly encouraged • Performs other duties as assigned Experience Required Highly-qualified scientists with a demonstrated ability to lead independent research projects, with experience in mentoring, training and project management. Translational cancer Research experience with strong background preferably on Lung Cancer, GI Cancer, or Breast Cancer with expertise in kinase signaling, drug resistance, surgical research. Proficiency in molecular techniques including bioimaging, flow cytometry, and animal model is preferred. Education Requirements Ph.D., MD, or MD/PhD or equivalent required.

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA™ platform encompasses two strategies: the CARTA (chimeric antigen receptor T cells for autoimmunity) strategy, with CABA-201, a 4-1BB-containing fully human CD19-CAR T, as the lead product candidate being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical trials in systemic lupus erythematosus, myositis, systemic sclerosis and generalized myasthenia gravis, and the CAART (chimeric autoantibody receptor T cells) strategy, with multiple clinical-stage candidates, including DSG3-CAART for mucosal pemphigus vulgaris and MuSK-CAART for MuSK myasthenia gravis. The expanding CABA™ platform is designed to develop potentially curative therapies that offer deep and durable responses for patients with a broad range of autoimmune diseases. Cabaletta Bio's headquarters and labs are located in Philadelphia, PA. For more information, visit ******************** and follow us on LinkedIn and X (Twitter). Uniquely Differentiated. Rapid. Elegant At Cabaletta, we are driven by the shared mission of developing cures, where a patients' own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew. We're proud to be a Great Place to Work-Certified™ company! #GPTWcertified Check out what our employees say makes working here so great: Working at Cabaletta Bio Inc | Great Place to Work About the Position The Associate Director / Director, Clinical Scientist will collaborate with cross-functional teams (Clinical, Regulatory, Medical Writing, Translational Sciences, CMC, etc.) on writing clinical study synopses and protocols, Investigator Brochures, and clinical study reports; review SAPs and TLF shells; participate in emerging clinical trial data evaluation and interpretation; ensure that assigned studies are conducted according to GCPs and Cabaletta's SOPs; conduct literature searches and reviews, meta-analyses, and publishing data; oversee the review of clinical study entries (clinical trial information and results) for posting to ********************** (clinical trial registry and results database) and assist in preparation of IND/ BLA filing and accelerated/pediatric programs packages. The span of responsibilities is broad and will support several clinical programs depending on their size and complexity. The Clinical Scientist will liaise with various vendors, and study investigators at participating sites. Responsibilities: Support the Medical Director or may serve as Clinical Lead in clinical science aspects of the assigned Cell Therapy program. Assists the Medical Director for clinical input to the clinical development plan (CDP) at all stages of the program. Leads (or supports) development of recommendations on further development strategies to internal committees. Member of the cross-functional clinical trial team for assigned studies. Participate in review of clinical and scientific data and developing product knowledge to understand and communicate the relevant information. Participate in development, maintenance, and review of clinical study documents (e.g., protocols and protocol amendment(s), informed consent documents, case report forms) and other relevant strategic documents. Support activities related to the start-up and execution of new clinical trials. Contribute relevant clinical sections to documents such as the IB, DSUR, CSRs, and for regulatory documents such as INDs/CTAs/ accelerated program/RMAT designations/pediatric study plans, and BLA/MAAs. Responsible for clinical data review and drafting reports and presentations on the various findings of the clinical research, including abstracts, posters, publications. Provide support with the activities related to the execution, monitoring, and reporting of clinical trials. Provides scientific/medical mentorship (or coordinates) to the study team, including the CRO team. Perform regular review of clinical data to ensure that the study is conducted in accordance with the protocol, safety procedures are followed, and efficiency is maintained. Assist with safety review procedures: tracking of safety events, review of new SAEs, and composing/editing adverse event narratives. Assist with managing vendor activities as needed. In collaboration with the Medical Director, identify clinical sites that will participate in trials. Interact with staff responsible for the design, set-up, execution, analysis and reporting of these studies. May attend Site Initiation Visits, to present the study design and key aspects of the protocol. Leads the compilation and interpretation of the data for and from safety review committees, collaborating closely with the Medical Director. Qualifications: Bachelor of Science degree from an accredited educational institution. Master's degree or PhD, PharmD/RN or the equivalent degree preferred. Minimum 7 years of experience in clinical drug development within a pharmaceutical/biotech or academic environment Strong knowledge of ICH, GCP, and other relevant regulatory guidelines Solid understanding of T-cell biology and cell & gene therapy Prior experience in cell therapy in pharma/biotech is a plus Experience in writing clinical protocols and performing and summarizing relevant literature reviews Strong communication and interpersonal skills Engaged, hands-on, and goal-oriented mentality in a highly dynamic work environment Ability to flexibly contribute simultaneously to multiple facets of drug development Demonstrated ability to learn new therapeutic areas and technologies Self-motivated, innovative, and critical thinker with strong commitment to follow up on action items Strong organizational, analytical, and problem-solving skills Thrives in a fast-paced small company environment and able to adjust priorities and workload based upon changing needs Strong team orientation and passion for continuous self-development Experience in the biotech industry or in a startup industrial setting is preferred. Our name - Cabaletta - is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long-term immunosuppression. For more information, please visit https://********************/join-our-crew Our most important asset is our people, and we offer competitive benefits, PTO, and stock option plans. Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Cabaletta Bio, Inc. does not accept unsolicited resumes from recruiters, employment agencies, or staffing firms. To conduct business with Cabaletta, a Master Services Agreement (MSA) must be executed and confirmed prior to submitting any information relating to a potential candidate. Without a signed MSA, Cabaletta shall not be responsible to any individual or entity for any payment relating to any form of fee or compensation. And, if a resume or candidate is submitted by a recruiter, an employment agency, or a staffing firm without a fully executed MSA, Cabaletta has the unrestricted right to pursue and hire any of those candidate(s) without any legal or financial responsibility to the recruiter, agency, and/or firm. #LI-REMOTE

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Title: Clinical Study Manager-Remote Location: Collegeville, PA Duration: 36 months Job Description: This position is needed to assist with Inspection Readiness Prepartion. The candidate will need to assist in leading diverse CRO teams through the Inspection Readiness process. Strong pTMF experience is also desired. A large component of the position will be to search for documents in pTMF and work with 2 different CRO to ensure that all documents are present in pTMF. Strong understanding of clinical trial documents is needed as well as a thorough understanding of a sponsor Inspection. The candidate should be flexible and able to positvely influence CRO staff while meeting the needs of the business. The candidate will also be asked to assist with filing protocol amendments in pTMF, ICD updates, and helping the COSTL and Clinican with tasks on an ad hoc basis. The candidate will lead 2 CROs through Inspection Readiness Activities for a large, high visibility, global oncology protocol that is in submission. The candidate needs to be able to influence and lead the 2 CROs through the Inspection Readiness checklist (~500 items). All items on the checklist will need to be reviewed, the location of the documents will need to be identified and entered onto the checklist. The candidate will need to be able to navigate through pTMF to ensure all documents are in pTMF in the correct cabinet and folder. The candidate will need to be proficient at searching for documents such as Monitoring Visit Reports, Financial Disclosure Documents, SOPs, vendor oversight plans. The candidate will need to compile a listing of relevant SOPs used on the study both past and present and download those SOPs into folders on a sharepoint space. The candidate will need to be comfortable leading 2 CROs in document retrieval and ensuring all Inspection Readiness Documents are up to date with the correct versions. The candidate will need to work with the 2 CROs for any corrections or updates needed. Additional Skills: pTMF, Inspection Readiness activities, Study conduct activities. Qualifications BS Additional Information For More information, Contact Best Regards, Akriti Gupta ************** Morristown, NJ 07960

Mindlance is a national recruiting company which partners with many of the leading employers in the Life Sciences, IT, and Financial Services sectors, feel free to check us out at ************************* Job Description • This role is to provide comprehensive project coordination support for reducing the risk of phishing by supporting Info Protect Culture Change Behavioral Research Project • Clinical experience is helpful but not mandatory • Provide operational support and project administration for the Info Protect Culture Change Behavioral Research Project. The role entails coordinating clinical project development and implementation, project monitoring and control, risk management, and project governance. Efforts must adhere to principles of transparency across the programs and enable comparability with other efforts. Incumbent will serve as an operational 'single point of contact'; Collaborate with internal and external partners and vendors; Develop and implement project activities as assigned by the project manager; Track study budget spend and report monthly; Review and reconcile invoices for payment approval; and create and maintain project documentation including project plans, meeting minutes and agenda, project risk and decision logs, and other documents needed for project execution. Qualifications • Experience running clinical trials or University studies not required but recommended. • Project Admin/Coordinator - Level of knowledge/expertise: Extensive capability and expert understanding Job Profile: project admin/coordinator Provide administrative project planning support to Programme/Project Manager as required and provide plans converted into various formats Convert the output of the PM meeting into a monthly report and maintain the ISAC and FPAC project tracking tools Provide support to the PMO as requested. • The Information Protection programme at multi-year global programme to protect information. Within the programme, there is an Information Protection Culture work stream with the goal to fundamentally drive worldwide employee culture change for protecting information through education and awareness.

About Us: Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Job Summary: Independently responsible for coordinating all aspects of multiple and/or complex clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies. Essential Responsibilities and Duties: Coordinates all aspects of patient involvement for complex and/or multiple studies from study initiation until study completion. Organizes research information for clinical trials. Observes subjects and assists with data analysis and reporting. Oversees study protocol scheduling and collection of data. Identifies, reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately. Manages, monitors, and reports research data to maintain quality and compliance. Performs administrative and regulatory duties related to the study as appropriate. Participates in other protocol development activities. Works collaboratively with internal departments, sponsors and investigators to ensure protocols are understood and assists in training staff members. Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.) Educates potential participants and caregivers on protocol specific details and expectations. Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned). Assists senior management with site qualification visits by knowledge of staff credentials, equipment, calibrations, and enrollment capabilities. Assesses and delegates daily tasks to research staff, ensuring goals of accuracy and timeliness. Trains, mentors, and/or manages Research Assistants and lower level Clinical Research Coordinators. Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. Education/Experience/Skills: Must have proper experience and demonstrate mastery of Clinical Research Coordinator II position. Bachelor's degree, preferred. CCRC certification preferred. 5 years of experience in the medical field or Masters Degree, preferred. Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials. Strong leadership and mentorship skills. Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level. Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations. Works independently as well as functioning as part of a team. Must be able to effectively communicate verbally and in writing. Working Conditions Indoor, Office environment. Shift work, depending on location. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds. Reporting to work, as scheduled, is essential. Overnight travel may be required for training and/or investigative meetings. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

Clinical Research Study Manager The Study Manager is responsible to ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. In addition, ensure study enrollment meets or exceed Sponsors' expectations and company goals are achieved on a timely basis. DUTIES & RESPONSIBILITIES Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA certifications on a timely basis. Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s). Adherence and compliance to the assigned protocols at their respective site(s). Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to Sponsor-provided and IRB-approved Protocol Training All relevant Protocol Amendments Training Any study-specific Manuals Training as applicable Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training. Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate and timely follow-up on the action items, at their respective site(s). Make sure that the most recent versions of the Protocol, Informed Consents, Study Manuals and all the other relevant study-related documents are utilized and implemented at all times for the assigned protocols at their respective site(s). Working knowledge of the Essential Clinical Trial Documents and maintenance of the Investigator Site Binders for their assigned protocol(s) at their respective site(s) Creating and or Reviewing Source Documents for their assigned protocol(s) at their respective site(s) in a timely manner. Responsible for training the site teams and supporting the adequate conduct of study subject visits, and all other relevant protocol required procedures and documenting these in a timely manner. Responsible for enforcing ALCOA-C Standards with all the relevant clinical trial documentation. Responsible for enforcing all Adverse and Serious Adverse Events reporting and any other relevant Safety Information reporting to the appropriate authorities per internal company guidelines, Sponsor, IRB and ICH-GCP Guidelines. Ensuring data quality, subject retention and compliance, and timely and adequate study data reporting on the assigned protocol(s) being conducted at their respective site(s). Working with the cross-functional team(s) and site team(s) to ensure study start readiness on all the aspects and adequate training completed by all the relevant site staff prior to FPFV and continue working with the cross-functional team(s) for the successful execution and completion of the clinical trial. Responsible for clinical trial management from FPFV to study close out with strict adherence to study protocol, adherence to all other relevant study manuals, study documents, ICH-GCP Guidelines, FDA Regulations, and ALCOA-C standards, organizational SOPs and guidance documents. Working closely with the Associate Site Director/Site Director to achieve strategic goals for the site. Assist the Associate Site Director/Site Director with staff training and any other relevant tasks assigned. Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s). Strive to ensure weekly, monthly and quarterly assigned goals are met for their respective site(s). Being prepared for and available at all required company meetings. Submitting required administrative paperwork per company timelines. Occasionally attending out-of-town Investigator Meetings. Any other matters as assigned by management. KNOWLEDGE & EXPERIENCE Education: High School Diploma or equivalent required Bachelor's degree preferred Foreign Medical Graduates preferred Experience: Minimum of 5 years experience in Clinical Research Supervisory experience preferred Wide therapeutic range of clinical trials experience preferred Regulatory research experience is a plus Credentials: ACRP or equivalent certification is preferred Knowledge and Skills: Goals-driven while continuously maintaining quality. Must be detailed-oriented, proactive, and able to take initiative. Must have strong written and communication skills. Must have excellent customer service skills. Bilingual in Spanish is a plus

We are seeking a Senior Clinical Project Manager (Sr. CPM) responsible for planning, execution, and oversight of clinical trials across multiple phases. This role ensures compliance with regulatory requirements, timelines, and budget constraints, involving cross-functional team leadership, vendor management, and collaboration with key stakeholders. The Sr. CPM will play a pivotal role in driving operational excellence in clinical trial execution. Responsibilities * Lead end-to-end clinical trial management from protocol development to study closeout. * Develop and maintain detailed project plans, timelines, and budgets. * Collaborate with regulatory teams for submissions, amendments, and compliance-related documentation. * Address protocol deviations, audit findings, and inspection readiness. * Select, negotiate, and manage relationships with CROs, central labs, and other external vendors. * Track performance metrics and ensure service level agreements are met. * Proactively identify study risks and develop mitigation strategies. * Address operational challenges, protocol deviations, and recruitment/retention issues. * Ensure efficient resource allocation to optimize study costs. * Monitor trial-related invoices and payments in collaboration with finance teams. * Act as the primary point of contact for all internal and external stakeholders. * Provide leadership and mentorship to junior project managers, CRAs, and study coordinators. * Foster collaboration among cross-functional teams, including Clinical Operations, Data Management, Medical Writing, Quality Assurance and Quality Control, Legal, Finance, and Senior Leadership, as well as external partners (CROs, Laboratories, Specialty service-providers, Investigators). * Ensure high-quality data collection and adherence to data integrity standards. * Work closely with data management and biostatistics teams to ensure timely database locks. * Provide regular study updates to senior leadership and stakeholders. * Develop strategies to optimize patient recruitment and retention. * Oversee site relationships, investigator engagement, and performance metrics. * Support protocol development and feasibility assessments. * Contribute to clinical development plans, study endpoints, and operational feasibility considerations. * Contribute to developing the organizational systems, including the development of SOPs, document management systems, and project finance management. * Ensure compliance with regulatory requirements and standard operating procedures, and timely management of project activities. * Perform any other duties as assigned by the supervisor. Essential Skills * Strong leadership, communication, and negotiation skills. * Ability to work in a fast-paced environment and manage multiple priorities. * Proficiency in clinical trial management systems (CTMS) and regulatory submission platforms. * Excellent problem-solving and risk management abilities. * Financial acumen for budget forecasting and cost control. Additional Skills & Qualifications * Bachelor's degree in life sciences, pharmacy, nursing, or a related field (Master's or PhD preferred). * 7+ years of experience in clinical trial management within the pharmaceutical, biotech, or CRO industry. * Proven experience in leading Phase I-IV clinical trials. * Strong understanding of GCP, ICH guidelines, FDA, EMA, and other regulatory requirements. * Experience managing CROs, vendors, and multi-site global trials. * Prior experience in neurology and rare diseases is a plus. * Experience working in an FDA-regulated and/or EMA-regulated environment. * Knowledge of adaptive trial designs and decentralized clinical trials is an advantage. Work Environment Our company is a clinical stage, specialty-focused bio-pharmaceutical firm dedicated to developing transformative treatments for rare and serious liver diseases and anemias. We offer a dynamic and goal-driven environment where employees are passionate about meeting objectives and making a difference. The work involves high visibility and provides opportunities for proactive individuals to take ownership of tasks. We offer a rewards program, cellphone reimbursement, tuition reimbursement, a matching 401K plan, and comprehensive benefits. The role requires domestic and international travel (10%). Pay and Benefits The pay range for this position is $130000.00 - $140000.00/yr. Other benefits are: Tuition reimbursement: 8K per year Holiday Pay 12 per year Vacation: at least 10 days annually Sick days 5 Annual performance bonus 10 - 15% Cell phone reimbursement $125 per month Workplace Type This is a hybrid position in Philadelphia,PA. Application Deadline This position is anticipated to close on Apr 23, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: * Hiring diverse talent * Maintaining an inclusive environment through persistent self-reflection * Building a culture of care, engagement, and recognition with clear outcomes * Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. 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.

Job Details Entry RO Malvern - Malvern, PA Full Time Day ShiftDescription Rothman Orthopaedics is looking to hire a per diem Medical Assistant to work as a Clinical Operations Specialist based in our Malvern, PA office! Schedule: As needed Monday through Friday 7:45 Am to 4:45 PM *MONDAY AVAILABILITY REQUIRED!* Job Summary: The Clinical Operations Specialist provides a blend of clinical and operations support to the office. Clinically, the COS will function as a Medical Assistant, Non-Surgical Clinical Assistant, or any other applicable clinical role as needed. In this capacity they will ensure the smooth flow of patients during office hours and support a variety of clinical and administrative functions. Operationally, the COS will serve as a Front Desk Receptionist or Front Desk Therapy Receptionist. The team member is responsible for greeting, checking in, verifying insurance, obtaining insurance referrals and any other applicable administrative tasks as needed. In this role the COS serves as a liaison between the patient and the medical staff in the office. The COS is an Operational role designed to meet the operational needs of the office - regular travel and schedule flexibility are inherent in this position. Key Accountabilities: Excellence in patient satisfaction, compliance with schedule prepping, responsiveness to voicemails, emails, and clinical messages, timeliness with pre-certifications and authorizations, compliance with all clinical policies and procedures, and adherence to documentation standards. Accurate collection of copays and capturing of referrals, efficient documentation of demographic and insurance information, obtaining referrals, excellence in time management and indepedent problem solving ability. As this is a support role designed to fill operational needs, utmost reliability and punctuality are vital. Essential Duties: Greet patients and visitors in a prompt, courteous, helpful manner. When applicable, maintain flow of patients from waiting room to exam room to discharge. Upon completion of their appointment, direct them to surgery scheduling and/or to the exit. Demonstrates a commitment to delivering unsurpassed service and quality patient care recognized by Patients, Physicians, Clinical Teams, Peers Check patients in by entering, verifying, and updating demographic and insurance information. Record arrival times, referral information, and payment information. Ensure RCM Console and Ready to Bill errors are addressed daily to ensure timely claims submission. Ensure referrals have been received, are in the patient's chart and attached Make follow up appointments for patients when needed or act as liaison to appropriate ancillary departments such as physical therapy and MRI. Answer telephone calls in friendly and professional manner, answer questions within their scope of knowledge, forward/transfer calls to the appropriate team members or take messages as needed. Handle correspondence within 24 hours of reception. Assist patients with ambulatory difficulties through the office. Follow procedure for requests for medical records and for Disability/FMLA paperwork. Take payment when necessary and document requests in the patient chart. Accurately batch out at end of shift and ensure all payments balance. Complete assigned paperwork and escalate any discrepancies to the office manager. Assist other team members with upset or irate patients by deescalating the situation and providing support. Maintain workspace in a neat and organized manner. Stock supplies in the lobby, front desk, pod workspaces, and exam rooms. Prep the schedule by obtaining referrals, confirming coverage status, and checking for any potential issues in advance of patient appointments. Reach out to patients prior to appointment when needed. Print out front sheets, last notes, and other requested documentation for the physician team. Attend meetings, participate in office activities, teambuilding exercises or special projects as required. Exemplify the culture and values of the organization in all interactions. Clean and autoclave instruments using proper sterile technique. Records vitals and medical history in the patient chart in accordance with MIPS guidelines, scan all pertinent documents into patient chart, obtain and record vitals, request and make available reports and images from outside facilities. Pull up/load/import pertinent studies for the physician, prepare for injection and aspiration procedures, dispose of biohazardous waste in accordance with OSHA regulations, replace sharps containers when full. Bring patients back to see the physician in efficient and timely manner; assist patients with clothing and preparing the body area to be examined. Empty and restock laundry. Complete pre-certifications and authorizations for imaging studies and injectable medications. Submit requests for authorizations to centralized departments as applicable. Provide follow up care and instructions to patients at conclusion of their appointment. Applies or removes casts/splints. Make orthotic devices by bending, forming and shaping materials to prescribed specifications. Fit, test and evaluate devices on patients and make adjustments for proper fit, function and comfort. Reads and responds to email communications within appropriate time frame. Identifies weekly schedule, including schedule changes, published by manager. Handle specimens (including urine, blood and drainage from incisions, aspirated fluids, etc.) and label accordingly. Follow order instructions of provider to ensure specimen is sent to appropriate lab for analyzation. Qualifications: High School Diploma or equivalent Active national Medical Assistant certification preferred Current CPR certification required Minimum (1) year in a medical office environment Medical office procedures and terminology Computer skills including but not limited to MS Office. Experience with scheduling and billing systems and EMR preferred. Basic medical assistant skills including phlebotomy, handling of body fluid samples, removal of sutures and staples, OSHA regulations preferred. Our Commitment to Employees: Come work at Rothman Orthopaedics! Our employees are our single greatest asset, as such, we strive to provide a professional, nurturing environment where every member of our team can make a meaningful difference in the lives of others. This commitment to our employees has earned us the distinction as a Top Workplace in Philadelphia by the Philadelphia Inquirer year after year. Our employees enjoy competitive pay, comprehensive health and dental benefits, tuition reimbursement, paid time off, and retirement savings plans. Rothman Orthopaedics is an Equal Opportunity employer committed to providing opportunities to all qualified applicants without regards to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. We value developing an inclusive and equitable environment that strengthens our organization and allows us to better attract and retain a diverse workforce that is representative of our patients and our community. We model our values by creating and enacting practices that encourage participation from all backgrounds, perspectives, and experiences. COVID-19 Policy: As a condition of employment at Rothman Orthopaedics, it is required you receive the COVID-19 vaccination. Rothman Orthopaedics is an Equal Opportunity Employer and requests for reasonable accommodations will be considered. Qualifications

Study Setup and Specimen Coordinator Job Title: Study Setup and Specimen Coordinator Location: Exton, PA/on-site Reports To: Project Manager, Team Lead Full-time Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. POSITION OVERVIEW: Key responsibilities of the position: When a new specimen is received, the Study Setup and Specimen Coordinator needs to Process e-Manifest Update Specimen Trackers Provide update to the clients regarding specimen status Work with Specimen Processing (BioA and Central Lab) closely on Sample Management including specimen status, problem reconciliation, as well as generation of related SOPs Work with BioA closely on analysis status for studies Assist laboratory management and QA specialist with CAPA, Change Control, and other processes Trouble Shooting Other responsibilities as needed Requirements: Has a High School Diploma or higher Experience working with laboratory specimens Has excellent communication skills ESSENTIAL SKILLS include the following: The skills listed below are representative of those that are required to perform this job successfully. Interview questions should be designed to verify/validate that the candidate possesses the specified below. High level of accountability with self and others Hands-on approach with a desire to teach others Track record of challenging the status quo Team and action-oriented Problem-solving Priority setting Salary and Benefits : Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Clinical Research Financial Analyst/ Billing Specialist - (233782) Description Performs data acquisition, qualitative and quantitative data analysis and planning. Assists with validating information and facilitates analysis of data in order to support operational and strategic decision making, such as sponsor invoicing, reconciliation of accounts and collections. EducationBachelors Degree : in Accounting, Finance or related field. (Required) Combination of relevant education and experience may be considered in lieu of degree. Experience1 year experience in a related position (Required) General Experience accessing data from a variety of systems (Preferred) General Experience in a healthcare provider environment (Preferred)_ Your Tomorrow is Here!Temple Health is a dynamic network of outstanding hospitals, specialty centers, and physician practices that is advancing the fight against disease, pushing the boundaries of medical science, and educating future healthcare professionals. Temple 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. Temple Health is proudly affiliated with the Lewis Katz School of Medicine at Temple University. 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. At Temple Health, your tomorrow is here!Equal Opportunity Employer/Veterans/DisabledAn Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Your Tomorrow is Here! As one of the first cancer hospitals in the country, Fox Chase Cancer Center has been a national leader in cancer treatment, research, and prevention for more than 100 years. Fox Chase Cancer Center, part of the Temple University Health System, is committed to providing the best treatment options for our patients, and delivering that care with compassion. At Fox Chase, we consider defeating cancer to be our calling. Our unique culture allows employees to work collaboratively with a single, shared focus, regardless of which department they're in. It's essential for us to recruit not only the best talent in hospital care, but hire well-qualified prospective employees who are committed to serving our patients with the passion and excellence for which Fox Chase is known. Apply today to be part of the future of prevailing over cancer. Primary Location: Pennsylvania-PhiladelphiaJob: FinanceSchedule: Full-time Shift: Day JobEmployee Status: Regular

Research Coordinator - TUCollaborative - (24003335) Description Grade: T25The link below will give you information about the University's “T” salary structure.A variety of important factors are reviewed by HR when considering salary, including job duties, the applicant's education and experience, all relevant internal equity considerations, department budget, and funding source.Learn more about the “T” salary structure. The Research Coordinator provides coordination of research and knowledge translation activities for the Temple University Collaborative on Community Inclusion. This includes overseeing IRB activities, such as managing timelines and communications for deadlines for IRBs (e.g., Temple University and City of Philadelphia IRBs). They will also manage the hiring processes including collecting applications, completing screenings for interviews, and coordinating with search committee to make hiring decisions. They will provide training and serve as the administrative supervisor (e.g., daily check-ins, support around research projects and Temple procedures, annual review) and offer support and guidance to research assistants. Supervision involves partnering with faculty who provide the direct supervision on research and knowledge translation activities. They will also oversee key activities of the center such as the purchasing card process, petty cash payments, and gift cards. They will also assist with organizing and monitoring training and technical assistance activities of the Center. Perform other duties as assigned, including some possible involvement with data collection efforts on specific research and knowledge translation projects. Essential functions:•Oversee IRB activities including managing timelines and communications for deadlines for both Temple University and City of Philadelphia IRB; Support IRB submissions; •Oversees hiring processes including collecting applications, completing screenings for interviews, and coordinating with search committee to make hiring decisions. •Provide training and administrative supervision to research assistants. •Oversee key activities of the center including the purchasing card process, gift cards, and petty cash payments through the Imprest account for reconciliations, and track participant reimbursement and other study related expenditures. •Facilitate and maintain positive relationships with research and community based collaborators; •Provide general organizational support and efforts related to maintaining an efficient, productive, and positive work environment; •Independently handles assignments or small projects related to Center operations and activities; •Prioritize workflow of tasks within established guidelines, subject to supervision of progress results; •Provide administrative support to various levels of leadership including the Center Director and collaborating faculty members in a multidisciplinary research team; •Perform recruitment, enrollment, data collection, data editing and data entry activities; •Identify best practices for subject recruitment and retention; •Assist with organizing and monitoring training and technical assistance activities of the Center. Performs other duties as assigned. At Temple, you will find it easy to fit in while staying true to yourself. We value what makes each employee unique and strive to maintain a culture of diversity and inclusion. As an employee, you will enjoy our collaborative team-based culture that values innovation and creativity. Visit ***************************************** to learn more about the benefits of working at Temple University. Required Education & Experience:Bachelors degree and at least three years of full-time research experience is required. An equivalent combination of education and experience may also be considered. Required Skills & Abilities:*Proficiency in computer skills, including Microsoft Office software programs.*Ability to function as a member of a multidisciplinary research team and to provide support to various levels of leadership.*Demonstrated ability to work independently and manage multiple tasks simultaneously.*Excellent interpersonal skills, with the ability to interact with a diverse stakeholder population to include community partners, clients and staff.*Strong organizational and time management skills.*Demonstrated ability to maintain a high level of attention to detail, and adherence to project deadlines.*Excellent written and oral communication skills.*Demonstrated organizational skills with the ability to handle multiple tasks.*Demonstrated ability to conduct research fact finding searches, including internet and scholarly literature searches*Ability to travel to off-site locations that may not be accessible via public transportation. Preferred:*A moderate level of leadership experience in research is preferred, including coordination of IRB activities and project leadership. *Research with individuals with mental illnesses is also preferred. This position requires a background check.This is a grant-funded position. This position is assigned a hybrid work arrangement (on-campus and remote), the duration of this hybrid work arrangement is at the discretion of Temple University and the Department. Temple University is committed to a policy of equal opportunity for all in every aspect of its operations, including employment, service, and educational programs. The University has pledged not to discriminate on the basis of age, color, disability, marital status, national origin or ethnic origin, race, religion, sex (including pregnancy), sexual orientation, gender identity, genetic information or veteran status. In accordance with the City of Philadelphia's COVID-19 mandate, all Temple University students, faculty, staff, and contractors working in a healthcare setting must be fully vaccinated before receiving authorization to work unless they have a medical or religious exemption approved by the University. An individual is considered fully vaccinated two (2) weeks following the second dose of the Pfizer or Moderna vaccine or two (2) weeks following a single dose of the Johnson & Johnson vaccine. Individuals who do not meet the University's vaccination or exemption requirement will be prohibited from working until proof of full vaccination or an exemption is requested and approved. For more information, visit the University's Vaccines web page at ******************************************** Compliance Statement: In the performance of their functions as detailed in the position description employees have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact. To obtain additional information about Temple University please visit our website at *************** Temple University's Annual Security and Fire Safety Report contains statistics, policies, and procedures related to campus safety and can be found at: ************************************************************* You may request a copy of the report by calling Temple University's Campus Safety Services at ************. Primary Location: Pennsylvania-Philadelphia-Main Campus-1700 N Broad StreetJob: StaffSchedule: Full-time Shift: Day JobEmployee Status: Regular

Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value. The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules. Job Summary The clinical scientist will provide scientific, clinical, and operational input to early and late stage clinical development programs. This role will work on cross-functional study teams for the design, execution, and monitoring of clinical trials, as well as assist with data interpretation and communication. Key Responsibilities Development of protocols for clinical studies. Contribute to the development of program strategy for assigned compounds/programs including participation in the preparation of clinical development plans Drafting and review of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other Health Authority submissions. Monitor, review and summarize safety and efficacy data in ongoing studies. Represent clinical development on project teams. Develop relationships with appropriate consultants and external experts and utilize these relationships to obtain feedback on protocol design. Clinical lead for study abstracts, posters, oral presentations and manuscripts for assigned studies. Serve as liaison to project teams, CRO's, Clinical sub-teams, and others. Maintain updated knowledge of competitive landscape in regards to assets with similar MOA and/or evolving standards of care for indications of interest. Qualifications Degree in scientific/life-sciences field. Pharm. D. or Ph. D. preferred. Minimum of 5 years of drug development experience are required. Alternative drug development experience will be considered. Prior Dermatology or immunology experience is preferred. Ability to work independently, multi-task, and work in a fast-paced environment. Excellent written and oral communication skills. Strong Analytical ability. Ability to accommodate up to 20% travel or as business dictates Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer. We Respect Your Privacy Learn more at: *********** incyte. com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here. You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. You can learn more about Incyte's data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable). Please contact privacy@incyte. com if you have any questions or concerns or would like to exercise your rights.

Clinical Research Coordinator (full-time) in Oncology supporting the Moseley Institute/NCCBD (Nemours Center for Cancer & Blood Disorders) - coordinates, implements and completes clinical research studies and/or clinical trials by assisting in screening hematology patients, obtaining parental permission/assent/consent forms, educating parents/participants, scheduling and conducting study procedures, collecting and recording study data, maintaining detailed study records, interfacing with study sponsors, participation in sponsor study monitoring visits, prepare for and participate in internal and external research audits, maintain various research databases, process and shipment of research samples, participation in continuous process improvement initiatives in the Delaware Valley. Please upload a RESUME and COVER LETTER outlining your qualifications and experience to the Nemours Job Portal. Essential Functions: 1. Follows all aspects of Standard Operating Procedures and Good Clinical Practices in the conduct of clinical research; collects and prepares documents as required by sponsoring agencies; attends Investigator Meetings, as assigned 2. Understands and can conduct clinical research studies that require but not limited to Emergent Access/Compassionate use, Multi-site clinical trials, conduct Investigator Initiated studies, Research Team training manuals 3. Participates in the conduct of parental permission/assent process for assigned studies; schedules study visits with study participants in accordance with study protocols; develops strategies to assure compliance of study participants with protocol requirements. 4. Supports NCCBD's NCORP: NCI Community Oncology Research Program across the Nemours enterprise. 5. Performs clinical data gathering, measurements and monitoring of data integrity, including data completeness, accuracy and quality. Maintains multiple study databases. Ability to be submit data proactively and address queries in a timely manner. 6. Participates in training nursing and ancillary study staff for study purposes; builds relationships with various departments to ensure protocol compliance. 7. Assists in identifying, reporting and following-up on Serious Adverse Events and/or Unanticipated problems 8. Assists in the maintenance of study medication accountability records; works closely with research pharmacist to coordinate study drug administration and documentation 9. Prepares clinical specimens for shipment to central laboratories. Ensures manual of procedures is followed and applicable documentation is sent with samples 10. Coordinates monitoring activities with Sponsor's representative(s). Completes Case Report Forms; responds to sponsor queries, prepares for audits by sponsor, IRB and/or the FDA/DHHS. 11. Attendance at and participation in relevant clinical divisional/departmental activities to assure routine administrative procedures are followed. Further attendance at Sponsor Coordinator meetings as needed for study related training. 12. Prepares for internal and external audits. Prepares corrective action plans as indicated QUALIFICATIONS: * Bachelor's degree in medical or science related field required; * Clinical Research Coordinator certification or eligible to sit for exam after 2 years clinical research coordination experience * Basic Life Support Certificate (may obtain upon hire) * Effectively uses Microsoft computer software; * Maintains the highest possible standards for work quality; accepts feedback; gives accurate information * Builds and fosters professional relationships with staff, families, and patients * Makes decisions when appropriate; manages resources prudently; schedules time efficiently; works independently * Demonstrates ability to coordinate and establish priorities among diverse tasks; * Effectively communicates verbally and in writing with patients, families, associates, and providers;

The Center for Healthcare Delivery Science (CHDS) at Nemours Children's Health in Delaware is seeking a full-time Clinical Research Coordinator (CRC). The CHDS is a research center across the Nemours enterprise. Anne E. Kazak, Ph.D., ABPP is the enterprise director, Melissa A. Alderfer, PhD is the Center Director in Delaware and Susana R. Patton, PhD, ABPP is the Center Director in Florida. The CHDS includes 20 investigators that study ways to improve health care, health equity, and health and wellness beyond medicine for youth and their families. Research projects span a variety of medical conditions (e.g., diabetes, pain, asthma, food allergy) and other health-related challenges (transition from pediatric to adult healthcare, behavioral interventions for depression, parental anxiety, and distress). This position is based at Nemours Children's Hospital - Delaware The CRC will be responsible for coordinating, implementing and completing research functions associated with studies in the CHDS. Essential CRC duties include coordinating IRB submissions, screening electronic health records, recruiting study participants, obtaining informed consent, interacting with youth, young adults and parents related to research projects, scheduling and conducting study procedures, collecting and recording study data, organizing participant payments, maintaining study records, participating in data collection and analysis, and the preparation of scientific presentations, manuscripts, reports, and grants. This position is ideal for individuals who intend to apply for graduate or medical training in a health-related field. The CRC will have the opportunity to engage in qualitative and quantitative data analyses, present at regional and national scientific meetings, help prepare manuscripts for publication, and obtain mentorship when applying to graduate/medical school. Position Requirements: Minimum of a bachelor's degree in psychology, pre-med, public health, or related. Must be able to effectively use Microsoft computer software, SPSS, and REDCap. Must be able to coordinate and establish priorities among diverse tasks. Previous research experience, including qualitative interviewing strongly preferred. Reliable transportation and a two-year commitment is preferred. Please upload a resume and cover letter outlining your qualifications and experience to the Nemours Job Portal.

Responsible for the overall operation of one or more research studies, coordinates research through project recruitment, scheduling and retention of study subjects and exercising appropriate communication skills in order to ensure retention of subjects in the study. This is a fully grant-funded position. Essential Functions Assist in identifying and recruiting eligible participants for research study. Ensure coordination of subjects and study personnel as required by protocol. Act as liaison between study personnel and study participants. Encourage and motivate participants to maintain compliance and attendance throughout the duration of the study and coordinate all aspects of retention. Maintain study records and related documentation as required by protocol and regulatory bodies (internal and external). Work with external study sites and coordinating centers as required. Participate in study meetings (in-person and by phone) as required. Perform study related testing and/or procedures as certified/trained. Maintain the highest level of confidentiality regarding patient and study records. Assist in the training of study support staff and student interns as assigned. Support and complete all study related paperwork including requirements of the Internal Review Board. Conduct screenings of preschool children as necessary to maintain recruitment goals (after training). Other related duties as assigned. Required Qualifications Minimum of Bachelor's Degree in or the equivalent combination of education and work experience. Please review the Equivalency Chart for additional information. Minimum of Experience working in a research environment desirable Proficiency in computer based operations including word processing, spreadsheets, REDCap and data base software. Excellent time management and organizational skills Excellent record keeping skills Ability to work independently Excellent interpersonal skills Comfortable working with children Familiarity with standard concepts, practices and procedures within study related field and study specific skills. Physical Demands Typically sitting at a desk/table Location The Eye Institute - Oak Lane Additional Information This position is classified as Exempt, grade J Compensation for this grade ranges from [$ 47,490 to $71,230 per year] [. Please note that the offered rate for this position typically aligns with the minimum to midrange of this grade, but it can vary based on the successful candidate's qualifications and experience, department budget, and an internal equity review. Applicants are encouraged to explore the Professional Staff salary structure and Compensation Guidelines & Policies for more details on Drexel's compensation framework. For information about benefits, please review Drexel's Benefits Brochure. Special Instructions to the Applicant Please make sure you upload your CV/resume and cover letter when submitting your application. Additional Required Documents A review of applicants will begin once a suitable candidate pool is identified.

Job Title Clinical Research Coordinator II Reporting to Regional Research Manager Permanent Full Time (1099) Contractor Position Provides study information and obtains relevant information as required by the protocol, from patients who are participating in, or interested in clinical studies. Assists in the recruitment and screening of volunteers, schedules patient visits in EMR, provides information to potential subjects and those participating in clinical trials and obtains relevant medical history by telephone and in person. Collects relevant medical records when needed. The CRC is responsible for meeting recruitment goals for each study. The methodology of recruitment will include, but is not limited to daily chart review, advertising when funds are available, referrals from rheumatologists and other staff and may include attending health fairs and community outreach. Reviews and administers the informed consent form to subjects; allowing them time to read and ask questions. Provides progress notes in EMR and source documents to describe procedures at each visit. Plans, prepares and performs tasks required by protocol, which may include, but not limited to the following: Obtaining patient medical history and medication lists Phlebotomy and basic laboratory tests Patient education and training ECG Administer Questionnaires Vital signs Assist with Joint counts and other assessments Data Entry Study drug administration, including injections Triages adverse events and communicates with the research physician regarding the occurrence of adverse and serious adverse events. Follow-up with the subject and collateral informants as needed. Provides educational information to subjects. Serves as a resource and support person for subjects and families by being a consistent person they can contact within the clinical research program. Ensures uniform implementation of protocols by completing required documentation in a consistent, accurate and timely manner. Assists in preparing appropriate Institutional Review Board (IRB) forms, informed consents, correspondence with sponsor, etc., in an accurate and timely manner. May participate in the annual IRB approval and update process. Serves as a liaison to all physicians and AARA employees. Ensures that primary referring physicians receive timely progress notes on the patient's diagnosis and treatment. May assume primary responsibility in the implementation and management of new clinical trials in a knowledgeable and collaborative manner. Performs all functions according to established policies (SOPS), procedures, regulatory and accreditation requirements, as well as applicable professional standards. Provides all AARR research subjects with an excellent service experience by consistently demonstrating professional decorum Assignment and Review of Work All new AARA employees will agree initial objectives to be assessed on completion of their 90-day initial review period. Thereafter, all employees will enter the annual appraisal cycle under the AARA Talent, Performance and Career Management Policy where annual appraisals will be conducted by their Line Manager and CRO. Further information on the appraisal cycle calendar is available from the HR Manager and from the Talent, Performance and Career Management Policy on the AARA Intranet. Communication and Relationships The postholder must have strong interpersonal and relational talents. Success in this role involves building and maintaining relationships with internal and external stakeholders Demands of the Job Role requires frequent light physical effort. The role requires a combination of sitting, standing and walking. Role requires frequent, moderate mental effort. The role requires a consistent high level of concentration, attention to detail and organization. Role requires frequent, light emotional exposure to distressing diagnoses. Occasional direct moderate emotional exposure to patients or relatives who may be ill, upset, distressed or angry. Role requires frequent exposure to hazardous materials and contact with contained bodily fluids. Requirements 11. Knowledge, Skill, Training and Experience to do the Job Essential Bachelors Degree in science related field Good Clinical Practice Certification (GCP) Clinical Research Coordinator Certification, (CRCC) preferred Experience in Phlebotomy & Clinical Assessments (Vitals, ECG, etc) Experience in biospecimen handling and processing