This full-time position is responsible for ensuring the integrity, quality, and compliance of clinical trials conducted at Astera Cancer Care.
Job Description:.
li>Prepares, completes, organizes and maintains of all study documentation forms, including drafting protocol amendments, case report forms, Electronic Data Capture (EDC), and other study specific documents. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.
Atlantic Health scored four "A" grades by The Leapfrog Group in its Fall 2025 Hospital Safety Grades, performance measures reflecting errors, accidents, injuries and injections, as well as systems hospitals have in place to prevent harm. The SPA I oversees the quality review and accuracy of Clinical Trial Agreements and Budgets and is responsible for tracking reports and perspective for refinement of operational activity in the Atlantic Health Clinical Research & Innovation Institute.
By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need. Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation to meet enrollment targets on assigned studies.
p>To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Senior Clinical Data Managers for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy.
Clinical Research Coordinator-Katz, under the direction of the Director, CRORA and Clinical Investigators, will be responsible for the planning, implementation, and execution of Clinical Research studies in one or more departments in the Lewis Katz School of Medicine at Temple University. *Must have strong written and verbal communication skills with the ability to interact with a diverse population of students, faculty, staff, sponsors, and research participants.
p>The position combines strong digital and AI domains with function-level business and transformation leadership, requiring the ability to produce decision-grade insights for CSO leadership, translate complex technology and regulatory constraints into strategic value hypotheses, and steer outcomes across highly matrixed, regulated environments. Direct and validate: Competitive and technology intelligence to inform strategic positioning, function-level business needs and value hypotheses, prioritization of business-driven requirements shaping product and roadmap decisions & gaps analysis against existing solutions and operating models.
p>If you are applying for a Research Post-Doctoral Fellow role, please refer to this link for salary guidelines (copy & paste into your browser): https://www.research.chop.edu/services/hiring-a-postdoctoral-fellow#collapse-accordion-3523-3. This role would provide opportunity for data collection, conduct independent scholarly research and develop new methods and protocols, participate in project planning, recording and evaluation of data, learn to conduct statistical analyses under supervision of a biostatistician, acquire manuscript and grant writing skills, participate in seminars, lectures, poster sessions and presentation at meetings, supervise junior lab members, and multidisciplinary team coordination.
p>Co-authors clinical sections of protocols, clinical investigator brochures, clinical study reports, Worldwide Marketing Application/Common Technical Document (WMA/CTD) subsections, and regulatory agency update and safety reports, as well as clinical development plans, publications, and abstracts. Experience managing Immunology and/or vaccine trials with an ability to think outside of the box, explore novel ways of working and comfortably navigate ambiguity to drive results also a plus.
The role encompasses supporting study risk assessments and defining RBQM study needs and strategies, which include determining the frequency and requirements for onsite versus remote monitoring activities, targeted SDV and SDR, and fostering constructive collaboration with cross-functional teams such as biometrics/data management, eTMF, and medical/safety monitoring. Review and collaborate to develop fit-for-purpose study plans that define risk-based monitoring strategies and the related tasks necessary to oversee critical study data and process (e.g., clinical monitoring plan, centralized monitoring plan, protocol deviation management plan, and integrated quality risk management plan).
p>Any offer of employment may be contingent upon receipt of acceptable results from a post-offer background screening, if required for the specific position, which may include, for example, identity verification, employment history, motor vehicle driving record history, and criminal or sexual offender records history. Westat has an immediate opening for a Research Assistant to contribute to ongoing health research exploring genetic, clinical, and environmental factors influencing cancer in individuals, families, and broader populations.
p>• PhD/PharmD in a relevant scientific discipline with a minimum of 5 years of progressively responsible experience in a pharmaceutical, biotechnology or related environment OR equivalent combination of experience and education. For over 25 years our team has been deeply committed to a unified purpose: Extending life's moments for children and adults living with a rare disease.
p style="margin: 0px 0px 10.6667px; padding: 0px; color: windowtext;"> ZS's R&D Excellence Practice brings together experts in Strategy, Clinical Execution, Data Sciences and Technology to empower client organizations achieve their passion for patient care, science and business success.
li>Effective problem solving abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations; prior experience in gene therapy trials preferred. Independently move a clinical trial through each phase of development, resolving issues and queries with input from a supervisor as required, prepare and submit regulatory packages, correspond with sponsor & regulatory review boards, and help with study start up activities Management of clinical trials and will need to use more independent judgment.
p>As part of the Department of Medicine, the DOM Clinical Trials Unit supports a diverse group of investigators, involving work on a wide spectrum of clinical trials ranging from phase I to IV, investigator and industry initiated, different disease states and varying complexities. Effective problem solving abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations.
The CRC-C may act in a lead capacity in coordination with CRU Research Team projects and assist Research Team Managers in overseeing the execution of project timelines as well as completion of study related activities delegated to the research coordinators(A/B) who provide study related support. Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility.
p>• Coordinate the conduct of Phase I - IV clinical trials including consenting, screening and enrolling eligible subjects, follow GCP guidelines in the conduct of trials, coordinate implementation of research protocols with study and clinical team, collecting and reporting research data, accessing and reporting AE/SAEs per protocol, managing subject treatment per protocol, oversight and coordination of research testing, including labs, office visits and radiology exams, coordinate subject care with clinical team, provide coverage and support to research coordinators. • Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility.
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