Clinical Research Associate Jobs in Newark, DE

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.

The Study Start-Up Manager (SSU Manager) is responsible at the country level for managing and conducting start-up activities in compliance with AstraZeneca procedures, documents, local and international guidelines such as ICH-GCP, and relevant regulations. The SSU Manager will prepare, review, track, and manage site regulatory documentation at both country and site levels, maintaining, reviewing, and reporting on site performance metrics. Working closely with CRAs and the Local Study Team/Local Study Associate Director, the SSU Manager ensures that study start-up activities and milestones are achieved efficiently and on time. Depending on experience, the SSU Manager may hold different internal titles, such as Senior SSU Manager. The Director, Country Head may assign these titles after confirmation with the Senior Director, Cluster Head / Executive Director, Regional Head. Accountabilities - Contribute to ensuring that clinical and operational feasibility assessments of potential studies are performed to the highest quality. - Accountable for study start-up and regulatory maintenance, including the collection, preparation, review, and tracking of documents for the application process. - Review informed consents at the site level, coordinate additional reviews with internal stakeholders, and facilitate the return of comments/approvals to sites for action. - Submit proper application/documents to Regulatory Authorities and/or IEC/IRB during the start-up period. - Actively participate in Local Study Team (LST) meetings. - Update CTMS and other systems with data from study sites as per required timelines during the start-up period. - Follow up on outstanding actions with study sites during the start-up period to ensure timely resolution. - Ensure timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, AZ SOPs, and local requirements. Support QC checks performed by LSAD or delegate to ensure that all country and site-level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness. - Provide regular information to Line Managers at the country level on study and planned study milestones/key issues during the start-up period. - Provide feedback on any research-related information including sites/investigators/competing studies that might be useful for the local market. - Support SMM in different initiatives (local, regional, or global) as agreed with the SMM Line Management. Essential Skills/Experience - Bachelor's degree in a related discipline, preferably in life science, or equivalent qualification. - Minimum 4+ years' experience with oncology startup. - Minimum 4+ years' experience with informed consent review. - Good knowledge of international guidelines ICH-GCP as well as relevant local regulations, basic knowledge of GMP/GDP. - Integrity and high ethical standards. - Good analytical and problem-solving skills. - Team-oriented and flexible; ability to respond quickly to shifting demands and opportunities. - Basic understanding of drug development process. - Good collaboration and interpersonal skills. - Good verbal and written communication skills. - Excellent attention to details. - Excellent understanding of Clinical Study Management and study start-up. - Good negotiation skills. - Good ability to learn and adapt to work with IT systems. Desirable Skills/Experience - Good medical knowledge and ability to learn relevant AZ Therapeutic Areas. - Good financial management skills. - Basic change management skills. - Good intercultural awareness. - Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. - Good analytical and problem-solving skills. - Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. - Good cultural awareness. At AstraZeneca, we are dedicated to following the science and pioneering new frontiers in Oncology. Our team is united by an ambition to eliminate cancer as a cause of death. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we push forward by fusing cutting-edge science with the latest technology. Backed by investment, we aim to deliver six new molecular entities by 2025. Our environment is built on courage, curiosity, and collaboration, empowering us to make bold decisions driven by patient outcomes. We are pioneers of collaborative research, working seamlessly with some of the world's foremost medical centers to expedite research in some of the hardest-to-treat cancers. Join us to build a rewarding career while improving the lives of millions living with cancer. Ready to make a difference? Apply now! The annual base pay for this position ranges from $ 105,735.20 - 158,602.80. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Date Posted 22-Apr-2025 Closing Date 18-May-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

APPLICATION INSTRUCTIONS: * CURRENT PENN STATE EMPLOYEE (faculty, staff, technical service, or student), please login to Workday to complete the internal application process. Please do not apply here, apply internally through Workday. * CURRENT PENN STATE STUDENT (not employed previously at the university) and seeking employment with Penn State, please login to Workday to complete the student application process. Please do not apply here, apply internally through Workday. * If you are NOT a current employee or student, please click "Apply" and complete the application process for external applicants. JOB DESCRIPTION AND POSITION REQUIREMENTS: The Beat Childhood Cancer Research Consortium at the Penn State College of Medicine, Hershey, PA, is hiring a full-time Clinical Trial Research Monitor. The Beat Childhood Cancer Research Consortium (BCC) is an international clinical research sponsor and acts as a Contract Research Organization (CRO) of a network of 50+ hospitals across the US and Canada that participate in BCC's investigator-initiated clinical trials. This job does require travel to BCC hospital sites for monitoring visits approximately every 4-6 weeks. The ideal candidate will have a strong background in Clinical Trial Management, Human Subjects Research, and IND/IDE regulatory requirements. It is important that the candidate have experience working with a team, multiple Principal Investigators, and Phase I/II clinical trial projects. The candidate must have strong verbal and written communication skills and be able to multi-task while fostering an environment of collaboration and teamwork. For more information on BCC visit our website: Home | Beat Childhood Cancer (beatcc.org) BCC Specific Position Roles: The Clinical Trial Research Monitor is primarily responsible for ensuring the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete, and verifiable from the source documents. This position is the primary contact between the Investigational Sites and BCC Leadership. Key responsibility of this position is ensuring that clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements and BCC SOPs. * Build relationships with Principal Investigators, study coordinators, pharmacists, and all relevant site trial personnel to ensure the efficient, expedited, and smooth management of clinical trials. * Foster internal and external relationships to ensure focus on efficient, timely and productive project delivery as per study requirements and timelines. * In collaboration with Regulatory teammates, understand the requirements of applicable local and international regulatory requirements as relevant to specific clinical trials. * Monitoring of investigational sites as per ICH GCP §5.18 (Monitoring) and the BCC Study Monitoring Plan for each BCC study. This includes all monitoring visit types across all phases of a clinical trial including Site Initiation, Site Monitoring and Site Close Out. Visits may be conducted either onsite or remote as needed. * Ensure the rights & wellbeing of trial participants are protected, including consent form checks, patient eligibility confirmation, protocol compliance, investigational drug compliance, and review of Adverse Events/SAEs. Ensure safety issues are reported to BCC promptly. * Verify trial data are accurate and complete, ensure CRF data and queries are completed and resolved as per the study timelines documented in the Study Monitoring Plan. * Ensure all study drug is appropriately stored, dispensed, accounted for, and reconciled as per the Study Monitoring Plan and the Protocol. * Provide guidance to sites to help establish and/or enhance processes for data collection and data management. Educate BCC enrolling sites staff concerning protocols, EDC and regulatory requirements and expectations. This position will be filled at an Advanced or Senior Professional depending on the candidate's education and experience. This position requires a Bachelor's Degree and 3+ years of relevant experience or an equivalent combination of education and experience. Advanced Degree or Certification preferred. This is a limited-term position funded for one year from date of hire, with possibility of refunding. This job requires that you operate a motor vehicle as a part of your job duties. A valid US driver's license and successful completion of a motor vehicle records check will be required in addition to standard background checks. Employment will require successful completion of background check(s) in accordance with University polices. The Pennsylvania State University is committed to and accountable for advancing diversity, equity, and inclusion in all of its forms. We embrace individual uniqueness, foster a culture of inclusive excellence that supports both broad and specific diversity initiatives, leverage the educational and institutional benefits of diversity, and engage all individuals to help them thrive. We value inclusive excellence as a core strength and an essential element of our public service mission. The salary range for this position, including all possible grades is: $68,200.00 - $115,100.00 Salary Structure - additional information on Penn State's job and salary structure. CAMPUS SECURITY CRIME STATISTICS: Pursuant to the Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics Act and the Pennsylvania Act of 1988, Penn State publishes a combined Annual Security and Annual Fire Safety Report (ASR). The ASR includes crime statistics and institutional policies concerning campus security, such as those concerning alcohol and drug use, crime prevention, the reporting of crimes, sexual assault, and other matters. The ASR is available for review here. Employment with the University will require successful completion of background check(s) in accordance with University policies. EEO IS THE LAW Penn State is an equal opportunity, affirmative action employer, and is committed to providing employment opportunities to all qualified applicants without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If you are unable to use our online application process due to an impairment or disability, please contact ************. Federal Contractors Labor Law Poster PA State Labor Law Poster Affirmative Action Penn State Policies Copyright Information Hotlines Hershey, PA

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.

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 (Primary function) The Assoc Dir, Clinical Research Scientist is responsible for working with the physicians within Clinical to provide clinical research support for programs as assigned by phase or therapeutic area. Essential Functions of the Job (Key responsibilities) Development of protocols for clinical studies. Preparation of clinical development plans. Drafting of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other FDA submissions. Monitor, review and summarize safety and efficacy data in ongoing studies. Assist with study design for exploratory development. Will lead the clinical matrix teams for assigned compounds. Represent exploratory development on project teams. Develop relationships with appropriate consultants. Write abstracts and present data at scientific meetings, both internally and externally. Serve as liaison to project teams, CRO's and others. Qualifications (Minimal acceptable level of education, work experience, and competency) Degree in scientific/life-sciences field. Pharm. D. or Ph. D. preferred. Minimum of 2 - 4 years of experience in research with at least 1 or more years of drug development experience are required. Prior Oncology Drug Development experience a plus. Ability to multi-task and work in a fast-paced environment. Excellent written and oral communication skills. Strong Analytical ability. 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.

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.

The Center for Healthcare Delivery Science (CHDS) at Nemours Children's Health is seeking a full-time Clinical Research Coordinator (CRC). Bilingual (English/Spanish) communication skills are preferred. The is based at Nemours Children's Hospital - Delaware in Wilmington. 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 Patton, PhD is the Center Director in Florida. The CHDS includes 18 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, cancer, cardiac conditions, obesity, sickle cell disease, cystic fibrosis, pain) and other health-related challenges (homelessness, maternal post-partum depression). The CRC will be responsible for coordinating, implementing and completing research functions associated with studies in the CHDS, many of which recruit Spanish-speaking families. Essential CRC duties include coordinating IRB submissions, 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. 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 Bilingual (English/Spanish) communication skills preferred.

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 Client develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine. Client 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. Their ultimate goal is to help people live healthy lives. They have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market - from patients to practitioners, from clinics to hospitals. 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. This individual will follow standard operating procedures . Responsible for management of to all evaluate all temperature excursions associated to clinical supplies during the trial execution ensuring prompt resolution and compliance with all SOP, GMP, Quality, and Regulatory guidelines, contributing to successful subject dosing within Janssen Pharma R&D for all phases of clinical trials.. Act as a single point of contact accountable for the business critical need. Manage and adjust supply dispositions via inventory systems including IVR & IWR based on the outcome of the temperate out of range evaluation. Conduct issue resolution activities for the temperature excursion supply aspects of the clinical trials. This individual will Develop strong internal collaboration with collaborate with GCDO, DPD, and Quality stakeholders to ensure for TOR resolution and overall customer satisfaction. Interface with Global Trial Managers, Trial Supply Managers, Drug Product Development, and Quality to manage trial supply temperature excursions. Responsible for execution of Temperature Monitoring Coordinator role during trial feasibility and throughout trial execution driving robust temperature management within company for all phases of clinical trials. They conduct the Review and approval of all Investigational Site Temperature Management Equipment Questionnaire Approvals (TMEQ) for Cold Chain IMP. Act as subject matter experts for They serve as subject matter consultants on temperature management requirements including storage and monitoring capabilities. They Customizing customize protocol specific temperature out-of-range forms based on product attributes. Coordinating Obtain quotes request and complete PO setup process to centrally source temperature monitoring devices. Develop strong internal collaboration with GCO stakeholders to ensure customer satisfaction. Partner with Global Trial Managers, Local Trial Managers, Site Managers, Local Medication Coordinators, Clinical Supplies Design Leaders, and Central Business Operations in temperature management and issue resolution. Supports Contribute to business process improvement initiatives. Responsible for the Temperature Management & Control of all clinical supplies from feasibility throughout trial execution in company Qualifications A minimum of a High School Diploma is required . A Bachelor's Degree is preferred. Two years' experience in a multi-disciplinary environment or Pharma R&D area is highly preferred. Experience with quality system tools are preferred (e.g. Trackwise ). Experience with Interactive Response Technologies for Clinical Trials (e.g. inventory management functionality) is preferred. Experience with the following functions is preferred, clinical operations, logistics, quality assurance, clinical supply chain planning and drug product development. Demonstrated knowledge in Clinical Supply Distribution and Clinical Study execution /GCP is preferred. Intermediate to advanced software skills (e.g., Microsoft Excel, SharePoint, PowerPoint ) is required. Experience in a highly matrixed environment is preferred. Excellent written and verbal communication skills are required. Additional Information Kind Regards, Sasha Sharma 732-662-7964 Integrated Resources, Inc.

The Rutgers University School of Nursing-Camden ( SNC ) invites applications for a Non-Tenure Track ( NTT ) position, with a focus on healthcare simulation. The successful candidate will have a strong background in simulation-based education, excellent communication and teaching skills, and a record of scholarly work aligned with Boyer's Model of Scholarship, which includes Discovery, Integration, Application, or Teaching and Learning. The ideal candidate will have demonstrated experience in simulation-based education, with a strong background in designing, implementing, and evaluating simulation experiences in healthcare. This includes a thorough understanding of high-fidelity manikins, standardized patients, and advanced simulation technologies, as well as proficiency with simulation management systems. The SNC offers a comprehensive range of nursing programs, including RN to BS, traditional and second-degree baccalaureate programs, MSN , DNP nurse practitioner tracks ( AGNP and FNP ), and an interdisciplinary PhD program with a focus on translational science for population health. The ideal candidate will leverage their expertise to further advance these programs, while fostering innovation and leadership in nursing education to meet the evolving healthcare needs of diverse communities. Position Responsibilities: Lead the Interprofessional Education, Practice, and Innovation ( IPEI ) Program, which fosters collaboration, integrates advanced simulation technologies, and promotes innovative teaching strategies to prepare students for real-world clinical practice. Coordinate simulation-based learning experiences, faculty development initiatives, and ensure that the program aligns with the latest healthcare trends and educational best practices. Advance interprofessional collaboration in scholarship and practice, supporting the growth of interdisciplinary education and promoting excellence in healthcare outcomes within the school of nursing and community. Collaborate with faculty to integrate cutting-edge simulation technology into curricula. Engage in curriculum development and enhancement, particularly in simulation-based learning. Participate in professional development and remain current in the field of simulation. Teach courses relevant to expertise or school needs. Overview Ranked #46 in U.S. News & World Report 's list of Best Public Colleges and Universities, Rutgers University-Camden is a diverse, research-intensive campus of approximately 6,100 students at the undergraduate, graduate, and doctoral levels and 1,100 faculty and staff members. Located in Camden, N.J., directly across the Delaware River from Philadelphia, the university is uniquely situated to serve the local community while achieving global reach. A U.S. Department of Education-designated Minority Serving Institution, the university thrives due to a supportive culture that helps students achieve their goals and fosters collaboration among employees. Rutgers-Camden is recognized as a national model for civically engaged urban universities and was selected by the Carnegie Foundation for the Advancement of Teaching for a Community Engagement classification. Washington Monthly magazine has ranked Rutgers University-Camden among its “Best Bang for the Buck” universities and best national research universities. Recently, Rutgers-Camden earned Carnegie classification as an R2 research university due to a high volume of internationally recognized research, creative output, and scholarly activity.

Are you a BCBA interested in leading a team of highly motivated individuals dedicated Devereux's mission? If so, consider being a Clinical Supervisor with us here at Devereux Advanced Behavioral Health! **Being a BCBA Supervisor at Devereux has its Advantages!** You will work with other dedicated professionals who share your passion for helping individuals in need. **YOU will be offered....** + **$2,000 sign on bonus!** + Consistent work schedule, M-F, 8am-4pm + Evidenced Based treatment and care models within a clinically based environment focused on collaboration and treatment teams. + CEU and continued education credits through various professional activities and Devereux's National Institute for Clinical Training and Research Center. + ASCEND- Career Accelerator Program + **BENEFIT ELIGIBILITY AFTER 30 DAYS OF EMPLOYMENT** (1st day of the 1st pay period after 30 days). Plan options that are affordable for you and your family. + **Annual compensation is $80,000 - $91,200 dependent upon education and experience** The **BCBA Supervisor** will supervise 3 BCBA/BA positions in the school program. This position will also provide supervision to BCBA candidates that need hours to complete their certification requirements - as well as assisting with supervising RBT staff in the school program. You will provide timely and meaningful performance feedback, and ensure that all performance assessments are completed on time. **The Devereux School for Integrated Learning focuses on building upon the unique strengths of each student. Our school strives to offer a breadth of opportunities for students to express themselves and find personal levels of accomplishment through activities such as: Special Olympics, talent shows and school dances, student government, peer mentoring, service learning, community gardening, and employment education, both in the classroom and in the community.** **Devereux Pennsylvania Children's Services (DPACS)** serves children, adolescents and young adults with autism spectrum disorders, intellectual and developmental disabilities, behavioral, emotional and psychiatric challenges and disorders. Located in West Chester and Malvern Pennsylvania, services provided include psychiatric residential treatment (PRTF), acute inpatient psychiatric hospital (AIP), assessment services, community-based mental health services, community-based employment training and social skills training, and approved private school educational services to male and female children and adolescents (6-21 years of age) with diagnoses of intellectual disabilities, autism spectrum disorders, concomitant psychiatric and behavioral challenges often associated with experiencing some level of trauma in their lives. \#sponsored **Qualifications** **EDUCATION:** Master's or Doctorate degree in Psychology, Applied Behavior Analysis, Education, Special Education, or relatedfield.Must be a BCBA. **EXPERIENCE:** Extensive experience in delivery of evidence based assessment and intervention practices for assigned clinical population. At least one year of supervisory experience required. Expertise in Positive Behavior Support as well as superior consultative and training skills required. Proficient computer skills, mastery of Microsoft Office Applications (especially Excel), experience with data collection/analyzing platforms (Radar, Pro-Filer, and/or other internal and external software applicationspertinent to the position). Strong organizational skills. Excellent oral and written communication skills. Requires ability to workindependently, prioritize, manage multiple tasks simultaneously, and adhere to established guidelines. Valid driver's license mustbe maintained. Devereux has a zero-tolerance policy for abuse and maintains policies and procedures to systematically reduce the risk of abuse to occur in our organization. Devereux fosters a culture of reporting abuse, and will cooperate with the authorities to the fullest extent possible. **Posted Date** _4 hours ago_ _(4/22/2025 12:33 PM)_ **_Requisition ID_** _2025-43923_ **_Category_** _Clinical_ **_Position Type_** _Full-Time_ **_Remote_** _No_ The employment policies of Devereux Advanced Behavioral Health are to recruit and hire qualified employees without discrimination because of race, religion, creed, color, age, sex, marital status, national origin, citizenship status, ancestry, disability, veteran status, communication ability, gender identity or expression or sexual orientation and to treat them equally with respect to compensation and opportunities for advancement - including upgrading, promotion and transfer - consistent with individual skills and the needs of Devereux.

1600 Haddon Ave5th Floor, Camden, New Jersey, 08103, United States of America DaVita is seeking a Clinical Coordinator who is looking to give life in a hospital setting. In this vital Registered Nurse role, you will have the opportunity to excel as the superior dialysis nurse, mentor and clinical expert you are-and have a dramatic impact on the lives of our patients and their families dealing with end-stage renal failure or chronic kidney disease. DaVita - which is Italian for "giving life" - is working to provide quality service to patients, partners, and teammates. Our mission is to be the Provider, Partner, and Employer of Choice. Some details about this position: * At least 6 months dialysis experience is required. * Coordinate ESRD patient care and services (trend lab values, track metrics on vital signs, weight, outcome management, etc.) * Ensure you and your clinical team are delivering the highest level of care to our patients by ensuring their safety, comfort, and well-being. * Training may take place in a facility or a training facility other than your assigned home facility * Potential to float to various facilities during and after your training * You must have a flexible schedule and be able to work mornings, evenings, weekends, and holidays What you can expect: * Build meaningful and long term relationships with patients and their family in an intimate outpatient setting. * Be a part of a team that supports and relies on each other in a positive environment. Staff RNs are a central part of a small interdisciplinary team of clinicians. * Deliver care to patients who are often dealing with multiple co-morbidities which require unique treatment plans and the ability to leverage a broad range of nursing skills and knowledge. * Oversee a group of patients with the support of PCTs to conduct patient observations, measuring stats and machine set up. * You will work with your head, heart and hands each day in a fast paced environment. What we'll provide: DaVita Rewards package connects teammates to what matters most including: * Comprehensive benefits: Medical, dental, vision, 401(k) match, paid time off, PTO cash out * Support for you and your family: family resources, EAP counseling sessions, access Headspace, backup child and elder care, maternity/paternity leave, pet insurance, and more * Paid training Requirements: * Current Registered Nurse (RN) license in the state of practice * Current CPR certification required * At least 18 months of registered nursing experience * Dialysis Charge RN readiness approval by clinical Nurse Manager or RN-licensed FA/GFA required * Certified Nephrology Nurse (CNN) or Certified Dialysis Nurse (CDN) preferred * Intensive Care Unit (ICU), Critical Care Unit (CCU), Emergency Room (ER), or Medical Surgical (Med Surg) experience is preferred * Associates Degree in Nursing (A.D.N) from accredited school of nursing required; Bachelor of Science in Nursing (B.S.N) preferred; three-year diploma from accredited diploma program may be substituted for nursing degree * Current CPR certification required * Completed training approved by the medical director and the governing body as required by CMS guidelines prior to operating the water treatment system * Supervisory experience preferred; willingness, desire, and ability to supervise required * Basic computer skills and proficiency in MS Word and Outlook required * This position also requires successful completion of the pre-employment color blind test, accommodation may be provided * Full vaccination against COVID-19 is required by hospitals in this program, which may include a booster when eligible DaVita is a clinical leader! We have the highest percentage of facilities meeting or exceeding CMS's standards in the government's two key performance programs. We expect our nurses to commit to improving patient health through clinical goal setting and quality improvement initiatives. Ready to make a difference in the lives of patients? Take the first step and apply now. #LI-SB3 At DaVita, we strive to be a community first and a company second. We want all teammates to experience DaVita as "a place where I belong." Our goal is to embed belonging into everything we do in our Village, so that it becomes part of who we are. We are proud to be an equal opportunity workplace and an affirmative action employer. As such, individuals are recruited, hired, assigned and promoted without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, protected veteran status, or any other protected characteristic. This position will be open for a minimum of three days. Salary/ Wage Range Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies and experience and may fall outside of the range shown. DaVita offers a competitive total rewards package, which includes a 401k match, healthcare coverage and a broad range of other benefits. Learn more at *********************************** Colorado Residents: Please do not respond to any questions in this initial application that may seek age-identifying information such as age, date of birth, or dates of school attendance or graduation. You may also redact this information from any materials you submit during the application process. You will not be penalized for redacting or removing this information.

"I feel very appreciated at my job; my team works well together to achieve a vision and I'm proud to be a part of it. Everyone has love and empathy for our patients. We let patients know we care and help them get through the day or even just the next moment. My boss takes the time to listen to me, encourages me and trusts me." Sabia M., RCA Employee RCA's Passion In 2013, Recovery Centers of America (RCA) announced a goal: Save one million lives from the disease of addiction. We're working fast and hard to fulfill that promise, with over 11 facilities that offer evidence-based inpatient, outpatient, and medication-assisted treatment 24 hours a day, 365 days a year. We know one size doesn't fit all when it comes to addiction treatment; that's why we tailor our treatment for each patient and offer specialized programs for patients with trauma and multiple recurrences, as well as programs for older adults, first responders, and more. We believe in the power of local treatment, because families are a huge part of the treatment and recovery process at RCA. Our family program rebuilds, restores, or strengthens family relationships. Our curriculum, resources, and evidence-based care were created to help patients not just achieve recovery, but maintain it for life. All of our services and treatment are delivered by clinical expertise - that's where you come in. As a Clinical Coordinator, you'll provide support and supervision on the quality of patient care as a member of a multi-disciplinary team and become part of our exciting mission of helping millions of people jumpstart their recovery. Position Overview: The Clinical Coordinator provides support and supervision of the quality of patient care as a member of a multi-disciplinary team. He/She also is responsible for the safe and effective operation of clinical services days, evenings and/or weekends. Assists with staffing and scheduling. Direct oversight of all clinical staff working within the units during their assigned shifts. Specific Responsibilities: * Oversight, supervision and quality assurance of all mental health and AOD clinical services, including record keeping and direct services. * Collaborates with the Clinical Director and/or Clinical Supervisor to facilitate team case conferences weekly to ensure coordinate implementation of treatment plans and service utilization. * Uses clinical assessment tools accurately, assessing each patient's psychological, psychosocial, safety and educational needs. * Appropriately documents all client interaction into the record for continuity of care. * Facilitates crisis de-escalation sessions with clients as needed. * Provides supervision and mentoring to the clinical staff on the shift * Participates in programming by providing individual and group counseling. * Communicates with inter-disciplinary departments, including nursing, regarding new admissions and sharing clinical observations on unit to ensure collaborative treatment approach. * Performs employee counseling and communicates incidents to the Clinical Supervisor. * This job description is not designed to cover or contain a full listing of activities, duties or responsibilities required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Education and Experience * Master's degree required with a major in chemical dependency, psychology, social work, counseling, nursing (with a clinical specialty in the human services) or other related field. * One year experience working in addictions * Excellent organizational skills and the ability to prioritize workload Competencies: Customer Service: Demonstrates concern for meeting internal and external customers' needs in a manager that provides satisfaction for the customer within the resources that can be made available. Impact and Influence: Works effectively with and through others including those whom there is no formal authority over. Project Management: Coordinates the diverse components of the project by balancing scope, time, cost, and quality. Communication: Communicates well both verbally and in writing, creates accurate and punctual reports, delivers presentations, shares information and ideas with others, has good listening skills. Work Environment: May work in various environments including professional offices, clinics, hospitals, or out-patient facilities. They spend much of their time on their feet, actively working with patients. Physical Demands: While performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to use hands to finger, handle or feel objects, tools or controls. The employee is occasionally required to stand, walk; sit; reach with hands and arms; climb or balance; and stoop, kneel, crouch or crawl. The employee must occasionally lift and/or move objects up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, peripheral vision and the ability to adjust focus. Travel: Travel is primarily local during the business day, although some out-of-the-area and overnight travel may be expected

$3,000 Hiring Bonus! Melmark Overview Melmark is a nonprofit organization providing clinically-sophisticated evidence-based special education, residential, vocational, and therapeutic services for children and adults diagnosed with autism spectrum disorders, developmental and intellectual disabilities, acquired brain injuries, medical complexities, and other neurological and genetic disorders. # Clinical Associate Overview The Clinical Associate is responsible for providing direct service instruction to assigned individuals while maintaining prescribed Level of Supervision (LOS) for assigned individual(s) at all times.# Responsibilities include attending to and maintaining individual#s hygiene, grooming, and dressing needs. Additional responsibilities include collecting data on all targeted behaviors for acceleration and declaration, in accordance with their function-based treatment plans and assisting with conducting functional analysis and treatment analysis sessions as overseen by the Clinical Team. Populations served are intensely physically challenging. Individuals who are served may exhibit aggressive and/or self-injurious behavior, therefore. Clinical Associates must be constantly alert and ready to respond to the individual#s needs in accordance with the prescribed behavior analytic interventions. # Schedule and Salary Information 3 weekday shifts 3pm-11pm and 1 weekend shift 7am-11pm Starting Rate: with at least 50 college credits- $20.00/hour (+) based on years of experience with a Bachelors degree- $22.50/hour (+) based on years of experience # # Requirements Bachelor#s degree strongly preferred; Minimum requirement of 50 College Credits A valid US driver#s license and a minimum age of twenty-one (21) years old.# Must be capable of attaining approved Melmark driver status.# Prefer at least one (1) year experience in a neurobehavioral stabilization unit or intensive residential setting strongly preferred. # Clinical Associate Responsibilities Maintains Level of Supervision (LOS) for assigned individual(s) at all times. Attends and maintains individual#s hygiene, grooming, and dressing needs Implements all procedures as written in each individual#s Behavior Support Plan and/or Protocol Summary. Accurately collects data on all targeted behaviors for acceleration and declaration on assigned individual(s) as indicated in Behavior Support Plan and/or Protocol Summary Responds appropriately during crisis (i.e., utilizing only approved crisis management techniques, being calm and composed, or acting quickly to protect others) as indicated in the crisis prevention training curriculum or each individual#s Protocol Summary or Behavior Support Plan (BSP). Implements all procedures as written in each individual#s Teaching Plans. Accurately collects data for all Teaching Plans at the time of the instructional session. # Benefits Work with a nationally known leader in quality-driven initiatives Generous Paid Time Off Benefits including Vacation, Holiday and Sick! Melmark Sponsored Pension Plan AND 403(b) with employer matching Health, Dental, Vision Insurance Flexible Spending Accounts for Health and Dependent Care Life, AD#D, and Disability insurance Tuition Reimbursement Generous Student Loan Reimbursement Professional Conference and Research Opportunities Onsite CEUs at no cost to employees General Responsibilities The Clinical Associate is responsible for providing direct service instruction to assigned individuals while maintaining prescribed Level of Supervision (LOS) for assigned individual(s) at all times. Responsibilities include attending to and maintaining individualâ€s hygiene, grooming, and dressing needs. Additional responsibilities include collecting data on all targeted behaviors for acceleration and declaration, in accordance with their function-based treatment plans and assisting with conducting functional analysis and treatment analysis sessions as overseen by a Clinical Specialist or Clinical Case Manager. Populations served are intensely physically challenging. Individuals who are served may exhibit aggressive and/or self-injurious behavior, therefore. Clinical Associates must be constantly alert and ready to respond to the individualâ€s needs in accordance with the prescribed behavior analytic interventions. Basic Qualifications Education/Training: Bachelorâ€s degree strongly preferred; Minimum requirement of 50 College Credits. Certifications/Licensure: A valid US driverâ€s license and a minimum age of twenty-one (21) years old. Must be capable of attaining approved Melmark driver status. Successful completion of employer provided certification in CPR, First Aid and Crisis Intervention. Skill(s): Working knowledge of Windows Operating Systems and Microsoft Office. Possess strong teaching skills with emphasis on individuals who are emotionally, behaviorally, physically and/or developmentally challenged. Ability to implement function based interventions for the reduction of challenging behaviors. Experience in the principles and application of Applied Behavior Analysis. Strong interpersonal and leadership skills are assets. Experience: Prefer at least one (1) year experience in a neurobehavioral stabilization unit or intensive residential setting strongly preferred.

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.

The Study Start-Up Manager (SSU Manager) is responsible at the country level for managing and conducting start-up activities in compliance with AstraZeneca procedures, documents, local and international guidelines such as ICH-GCP, and relevant regulations. The SSU Manager will prepare, review, track, and manage site regulatory documentation at both country and site levels, maintaining, reviewing, and reporting on site performance metrics. Working closely with CRAs and the Local Study Team/Local Study Associate Director, the SSU Manager ensures that study start-up activities and milestones are achieved efficiently and on time. Depending on experience, the SSU Manager may hold different internal titles, such as Senior SSU Manager. The Director, Country Head may assign these titles after confirmation with the Senior Director, Cluster Head / Executive Director, Regional Head. Accountabilities - Contribute to ensuring that clinical and operational feasibility assessments of potential studies are performed to the highest quality. - Accountable for study start-up and regulatory maintenance, including the collection, preparation, review, and tracking of documents for the application process. - Review informed consents at the site level, coordinate additional reviews with internal stakeholders, and facilitate the return of comments/approvals to sites for action. - Submit proper application/documents to Regulatory Authorities and/or IEC/IRB during the start-up period. - Actively participate in Local Study Team (LST) meetings. - Update CTMS and other systems with data from study sites as per required timelines during the start-up period. - Follow up on outstanding actions with study sites during the start-up period to ensure timely resolution. - Ensure timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, AZ SOPs, and local requirements. Support QC checks performed by LSAD or delegate to ensure that all country and site-level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness. - Provide regular information to Line Managers at the country level on study and planned study milestones/key issues during the start-up period. - Provide feedback on any research-related information including sites/investigators/competing studies that might be useful for the local market. - Support SMM in different initiatives (local, regional, or global) as agreed with the SMM Line Management. Essential Skills/Experience - Bachelor's degree in a related discipline, preferably in life science, or equivalent qualification. - Minimum 4+ years' experience with oncology startup. - Minimum 4+ years' experience with informed consent review. - Good knowledge of international guidelines ICH-GCP as well as relevant local regulations, basic knowledge of GMP/GDP. - Integrity and high ethical standards. - Good analytical and problem-solving skills. - Team-oriented and flexible; ability to respond quickly to shifting demands and opportunities. - Basic understanding of drug development process. - Good collaboration and interpersonal skills. - Good verbal and written communication skills. - Excellent attention to details. - Excellent understanding of Clinical Study Management and study start-up. - Good negotiation skills. - Good ability to learn and adapt to work with IT systems. Desirable Skills/Experience - Good medical knowledge and ability to learn relevant AZ Therapeutic Areas. - Good financial management skills. - Basic change management skills. - Good intercultural awareness. - Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. - Good analytical and problem-solving skills. - Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. - Good cultural awareness. At AstraZeneca, we are dedicated to following the science and pioneering new frontiers in Oncology. Our team is united by an ambition to eliminate cancer as a cause of death. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we push forward by fusing cutting-edge science with the latest technology. Backed by investment, we aim to deliver six new molecular entities by 2025. Our environment is built on courage, curiosity, and collaboration, empowering us to make bold decisions driven by patient outcomes. We are pioneers of collaborative research, working seamlessly with some of the world's foremost medical centers to expedite research in some of the hardest-to-treat cancers. Join us to build a rewarding career while improving the lives of millions living with cancer. Ready to make a difference? Apply now! The annual base pay for this position ranges from $ 105,735.20 - 158,602.80. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Date Posted 11-Apr-2025 Closing Date 30-May-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

APPLICATION INSTRUCTIONS: * CURRENT PENN STATE EMPLOYEE (faculty, staff, technical service, or student), please login to Workday to complete the internal application process. Please do not apply here, apply internally through Workday. * CURRENT PENN STATE STUDENT (not employed previously at the university) and seeking employment with Penn State, please login to Workday to complete the student application process. Please do not apply here, apply internally through Workday. * If you are NOT a current employee or student, please click "Apply" and complete the application process for external applicants. JOB DESCRIPTION AND POSITION REQUIREMENTS: The Beat Childhood Cancer Research Consortium at the Penn State College of Medicine, Hershey, PA, is hiring a full-time Clinical Trial Research Coordinator. The Beat Childhood Cancer Research Consortium (BCC) is an international clinical research sponsor and acts as a Contract Research Organization (CRO) of a network of 50+ hospitals across the US and Canada that participate in BCC's investigator-initiated clinical trials. This position supports clinical trial research across these 50+ hospital sites and has a specialized focus on research project operations including study methodologies, protocol development, logistical support, project management and timelines. For more information on BCC visit our website: Home | Beat Childhood Cancer (beatcc.org) Job Duties & Responsibilities: * Complete assigned projects, develop work plans, and oversee project phases to ensure effective and efficient workflow. * Maintain compliance with Good Clinical Practice (GCP) guidelines and applicable regulations throughout the trial life cycle. * Develop and assist in administering regulatory compliance for the Beat Childhood Cancer Research Consortium. * Provide training and support to study site personnel on protocol requirements, study procedures, and regulatory compliance. * Serve as a resource for study teams and investigators regarding study-related inquiries and issues. Maintains communication and contact lists across 50+ sites. * Help to develop and maintain Study Specific Case Report Forms and study documents as well as verbiage in clinical trial protocols and supporting documents. * Develop relationships with BCC and University staff, research collaborators, other BCC institutions, and regulators as necessary and in the best interests of the program. Teammate will evaluate and resolve issues or problems as they arise. * Develop and implement new guidelines and procedures that will streamline the office operations. * Flexibility to adapt to changing circumstances. * Excellent organizational skills, multitasking and communication both written and spoken. The ideal candidate will have a strong background in REDCap data entry and experience working with central Institutional Review Boards (IRB). It is important that the candidate have experience working with a team, multiple Principal Investigators, and Phase I/II clinical trial projects. The candidate must have strong verbal and written communication skills and be able to multi-task while fostering an environment of collaboration and teamwork. Minimum Education & Experience: * Bachelor's Degree * 3+ years of relevant experience * Or an equivalent combination of education and experience This is a limited-term position funded for one year from date of hire, with possibility of refunding. The following clearances must be successfully completed for this position: * Pennsylvania State Police Criminal Background Check * Pennsylvania Child Abuse History * Federal Bureau of Investigation (FBI) Criminal Background Check The Pennsylvania State University is committed to and accountable for advancing diversity, equity, and inclusion in all of its forms. We embrace individual uniqueness, foster a culture of inclusive excellence that supports both broad and specific diversity initiatives, leverage the educational and institutional benefits of diversity, and engage all individuals to help them thrive. We value inclusive excellence as a core strength and an essential element of our public service mission. The salary range for this position, including all possible grades is: $56,200.00 - $81,500.00 Salary Structure - additional information on Penn State's job and salary structure. CAMPUS SECURITY CRIME STATISTICS: Pursuant to the Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics Act and the Pennsylvania Act of 1988, Penn State publishes a combined Annual Security and Annual Fire Safety Report (ASR). The ASR includes crime statistics and institutional policies concerning campus security, such as those concerning alcohol and drug use, crime prevention, the reporting of crimes, sexual assault, and other matters. The ASR is available for review here. Employment with the University will require successful completion of background check(s) in accordance with University policies. EEO IS THE LAW Penn State is an equal opportunity, affirmative action employer, and is committed to providing employment opportunities to all qualified applicants without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If you are unable to use our online application process due to an impairment or disability, please contact ************. Federal Contractors Labor Law Poster PA State Labor Law Poster Affirmative Action Penn State Policies Copyright Information Hotlines Hershey, PA

Study Setup and Specimen Coordinator Job Title: Study Setup and Specimen Coordinator 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.

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.