div>Celerion, a leader in clinical research, is seeking a full-time
Lead, Clinical Research Associate to oversee monitoring and site management activities for clinical trials, clinical investigations and other interventional or non-interventional studies.
Celerion is committed to swift, exceptional clinical research through translational medicine.
Typically involved in all stages of the clinical study, including identifying potential sites to participate in the research effort, performing various study start-up activities such as working with sites to collect appropriate regulatory documents and supporting the negotiation of contracts and budgets, training the sites to collect data properly and report any potential safety-related events, managing the site's activities during study maintenance, and closing down research activities at the sites once the study has concluded. As a Clinical Research Associate (CRA) at Worldwide, you will find yourself working alongside brilliant minds across diverse therapeutic areas, including Cardiovascular, Metabolic, Neuroscience, Oncology, and Rare Diseases.
Typically involved in all stages of the clinical study, including identifying potential sites to participate in the research effort, performing various study start-up activities such as working with sites to collect appropriate regulatory documents and supporting the negotiation of contracts and budgets, training the sites to collect data properly and report any potential safety-related events, managing the site's activities during study maintenance, and closing down research activities at the sites once the study has concluded. As a Clinical Research Associate (CRA) at Worldwide, you will find yourself working alongside brilliant minds across diverse therapeutic areas, including Cardiovascular, Metabolic, Neuroscience, Oncology, and Rare Diseases.
li>Typically involved in all stages of the clinical study, including identifying potential sites to participate in the research effort, performing various study start-up activities such as working with sites to collect appropriate regulatory documents and supporting the negotiation of contracts and budgets, training the sites to collect data properly and report any potential safety-related events, managing the site's activities during study maintenance, and closing down research activities at the sites once the study has concluded.
As a Clinical Research Associate (CRA) at Worldwide, you will find yourself working alongside brilliant minds across diverse therapeutic areas, including Cardiovascular, Metabolic, Neuroscience, Oncology, and Rare Diseases.
li>Typically involved in all stages of the clinical study, including identifying potential sites to participate in the research effort, performing various study start-up activities such as working with sites to collect appropriate regulatory documents and supporting the negotiation of contracts and budgets, training the sites to collect data properly and report any potential safety-related events, managing the site's activities during study maintenance, and closing down research activities at the sites once the study has concluded.
As a Clinical Research Associate (CRA) at Worldwide, you will find yourself working alongside brilliant minds across diverse therapeutic areas, including Cardiovascular, Metabolic, Neuroscience, Oncology, and Rare Diseases.
It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. This includes teaching and training users in the correct manner to ensure our products are used safely and effectively - both for the preservation of organs prior to transplant, and for various clinical and non-clinical research studies.
p>The Research Program Manager will provide high-level program management across the MIG Lab and BNIC, coordinating complex, data-intensive projects, aligning timelines and deliverables, and ensuring organized, compliant operations that enable PIs and teams to execute impactful neuroimaging and omics research at scale. The Barrow Neuroimaging Innovation Center (BNIC) is a 6,000+ square-foot imaging research facility with a research-dedicated 3T MRI and advanced acquisition capabilities, supporting cutting-edge structural and functional neuroimaging for internal and external investigators.
li>Complete study documentation and maintenance of study files in accordance with sponsor requirements and GI Alliance RESEARCH policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms. By combining deep clinical trial expertise with cutting-edge AI, we connect sponsors' scientific ambitions with high-performing research teams that expedite and expand access to novel therapeutics for patients in need.
Partner with Territory Managers to achieve sales quotas in all Alternate Care markets; Identify problem areas to implementation of Masimo technology and work to resolve these issues; Work with Territory Managers to coordinate Alternate Care customer installations in conversion to Masimo SET, Rainbow, SpHb and PSN; Manage or assist with the installation process and personnel; Coordinate clinical evaluations of Masimo technology for both clinical investigators, customers, and OEM partners; Support Trade Shows; Assist in the clinical education, follow up, and training needs of clinicians and sales force; Participate in continued evaluation of new products and assist in beta testing; Perform clinical evaluation of Masimo technology including customer research and focus groups, as required; Extensive domestic travel is a major job component; Performs other duties or special projects as requested; Minimum & Preferred Qualifications and Experience: Minimum Qualifications. Five or more years of experience in the clinical arena related to alternate care markets; Very strong, written, verbal communication and interpersonal skills; Must be results oriented with positive "can do" attitude with a sense of urgency to get things done; Comfortable in high visibility situations, exhibits strong self-confidence; Proven track record in persuading clinicians to consider and embrace new ideas, with an emphasis on new patient care processes based on clinical evidence and new, innovative technologies; Independent problem solver; Organized and detail oriented with a demonstrated ability to manage multiple projects simultaneously; Must be able to professionally communicate effectively with management, executives, physicians, staff, peers, sales reps and customers; Must be able to maintain an extensive domestic travel schedule; Preferred Qualifications.
p>The Clinical Research Grader performs clinical grading and performs imaging and instrumentation analysis of study participants on clinical research trials. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.
Examples of the skills, knowledge, and experiences you need to lead and deliver value at this level include but are not limited to: • Craft and convey clear, impactful and engaging messages that tell a holistic story. PwC does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: https://pwc.to/H-1B-Lottery-Policy.
JOB RELATIONSHIPS: • Reports to the Director of Clinical Research, Vice President of Research, Regional Market President, and the physicians at the local market • Collaborates with experienced patient navigators, IT, data management, and Urology America clinical research staff. • Mentors Clinical Research Coordinators I and II, Research Assistants, and Research Interns providing guidance during new hire training, trial initiations, and transitions.
Primary Responsibilities: You are responsible for the overall management of assigned Clinical Studies to include: On-time performance with defect-free execution of each study, working with support divisions to ensure timelines are being met in clinical studies (i.e. recruiting, data management, statistics), Organizing study initiation meetings to plan execution of study, Facilitating study review meetings for pre-study, in-process and post study review, Problem solving as needed during study conduct, Meeting with clients as needed throughout study, and organizing study logistics and personnel. Primary Responsibilities: On-time performance with defect-free execution of each study, working with support divisions to ensure timelines are being met in clinical studies (i.e. recruiting, data management, statistics), Organizing study initiation meetings to plan execution of study, Facilitating study review meetings for pre-study, in-Problem solving as needed during study conduct, Meeting with clients as needed throughout study, and organizing study logistics and personnel.
Chandler, Arizona30+ days ago
This policy relates to all phases of employment, including, but not limited to, recruiting, employment, placement, promotion, transfer, demotion, reduction of workforce and termination, rates of pay or other forms of compensation, selection for training, the use of all facilities, and participation in all company-sponsored employee activities. Responsible for the recruitment and screening of potential participants, which includes chart review of patients and schedules, contacting leads from outside recruitment efforts, and following up on referrals from all sources.
Peoria, Arizona30+ days ago
This policy relates to all phases of employment, including, but not limited to, recruiting, employment, placement, promotion, transfer, demotion, reduction of workforce and termination, rates of pay or other forms of compensation, selection for training, the use of all facilities, and participation in all company-sponsored employee activities. Responsible for the recruitment and screening of potential participants, which includes chart review of patients and schedules, contacting leads from outside recruitment efforts, and following up on referrals from all sources.
Scottsdale, AZ30 days ago
Sterile Compounding (USP ): Maintain a sterile environment for preparing sterile compounds and apply rigorous aseptic techniques to prevent contamination and ensure patient safety. Monitor Visits: Meet with Clinical Research Associates (CRAs) during monitoring visits to review pharmacy binders, drug accountability records, and resolve queries.
Monitor and review study budget and data management activities, such as PRF development, training, and facilitating query resolution with proper documentation • Support monitoring efforts by setting quality and compliance goals by overseeing and approving study monitoring plans, may review, suggest edits and approve monitoring trip reports • Contribute to contract review and negotiations with outside vendors and study sites or laboratories • Mentor CTMs and CRAs • Demonstrate an ability to influence others to achieve positive results and collaboration through diplomacy and respect for others, appropriate prioritization and facilitation of the decision-making process Qualifications Qualifications: • Bachelors degree or higher, or equivalent credentials • Knowledge of GCP, ICH guidelines, and other clinical regulatory requirements • Strong interpersonal skills (verbal and written), organizational, and prioritization skills, able to communicate at multiple levels of an organization and with sponsors/clients. Primary Responsibilities (all levels): • Manage, design and implement all clinical operational aspects of IVD clinical trials from inception through close-out • Serve as main point of contact for internal and external study stakeholders; effectively communicating, collaborating, managing escalation of issues, where necessary, as well as participating and leading internal and external study meetings • Identify, evaluate, and oversee qualification and contracting for study investigators, study sites, CRO and/or vendor management for the study, where applicable • Develop or assist in the development of study-related plans and documents including protocols, informed consent forms, monitoring plans, case report forms, training plans and engagement materials • Ensure trial master file (TMF/eTMF) is established, current, and maintained per ICH E6.
The CRC will coordinate and support all aspects of clinical trials and research studies, including subject recruitment, data collection, regulatory compliance, and specimen handling. Candidates with current Phlebotomy certification or Medical Assistant (MA) certification are strongly preferred, as this role may include specimen collection and basic clinical procedures.
p>Provide experienced leadership to a team of Clinical Research Associates involved in clinical studies that are executed at the sites conducting clinical research studies This includes, but is not limited to: - Direct supervision / line management of CRA staff and contractors in the team in accordance with Celerion policies and applicable regulations. This includes, but is not limited to:
- Implementation and monitoring of clinical studies to ensure sponsor and investigator obligations are being met in compliance with local regulatory requirements, Good Clinical Practice, and the respective protocol or investigational plan as follows:
- Ensure monitoring activities are occurring according to contract, monitoring plan and SOPs.
This role partners closely with the Regional Clinical Practice Director (RCPD) to implement regional strategy, ensure consistency in care delivery, and support provider engagement, performance, and compliance. The Clinical Practice Manager (CPM) is responsible for executing clinical and operational initiatives within assigned facilities and supporting the performance of providers at the market level.
Phoenix, Arizona30+ days ago
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Paradise Valley, AZ30+ days ago
p>• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market.
Minimum prior work experience of 4+ years as a Clinical Research Nurse or equivalent role supporting clinical trial project management at a medical device/drug company, clinical research site, or CRO. Assist data management staff with clinical data review and collection of data from sites to maintain integrity by reviewing protocol deviations, adverse events, data inconsistencies, outliers, other issues as identified.
Phoenix, Arizona23 days ago
div style="background-color:transparent;color:black;font-family:'tahoma';font-size:10pt;font-weight:bold;text-align:left;border-style:none;border-color:transparent;border-width:1px;margin-left:0px;margin-top:0px;margin-right:0px;margin-bottom:0px">EDUCATION
- Bachelors in healthcare administration, nursing, business, life sciences, or related field OR equivalent combination of education and related experience may be considered in lieu of degree Required .
EXPERIENCE
- 3 years in clinical research, healthcare billing/compliance, or related field with direct responsibility for clinical trial coverage analyses or equivalent functions.
Joseph's includes the internationally renowned Barrow Neurological Institute, Norton Thoracic Institute, Cancer Center at St. Joseph's, Ivy Brain Tumor Center, and St. Located conveniently in the heart of Phoenix, Arizona, St. Joseph's Hospital and Medical Center is a 571-bed, not-for-profit hospital that provides a wide range of health, social and support services.
The Clinical Risk Program Manager collaborates with senior leaders and key stakeholders or experts, (e.g., Clinical Operations, Patient Safety, Supply Chain, Legal, and Regulatory Services), throughout Phoenix Children's to investigate risk incidents and to develop system-wide responses to risk issues that impact specific groups or the entire organization with policies/procedures, guidelines, tools, forms, and education/training. Ensures the quality of legal services for HPL lawsuits and the efficient use of funds allocated for legal expenses by directing the activities of outside defense counsel, performing internal audits of defense legal services and continually evaluating strategic alternatives and opportunities for early mediation/resolution of claims and litigation.
The Clinical Research Technologist in the clinical research laboratory can be placed on a track towards obtaining American Society of Clinical Pathology (ASCP) Technologist in Molecular Biology (MB) board certification if not already credentialed upon hire. Minimum 24 semester hours of medical laboratory technology courses or 24 semester hours of science courses, including 6 semester hours of both Chemistry & Biology & an additional 12 semester hours in any combination of Chemistry, Biology, or Medical Laboratory.
The Manager, Clinical Service also serves as a liaison with other departments to plan, implement, communicate, evaluate and coordinate patient care operations across the enterprise, while also facilitating quick resolution of issues to ensure excellence in a family centered care environment. As needed, provides developmentally appropriate clinical care within professional domain to ensure delivery of quality integrated developmentally appropriate patient care; participates as appropriate in emergent situations.
Phoenix, Arizona30+ days ago
Analysts at this level are accountable for managing their portfolio of agreements from intake through execution, collaborating with investigators, legal counsel, and business operations partners to expedite trial start-up. Behind every smile is a highly skilled professional with deep expertise and an unwavering dedication to what matters most — caring for the health and well-being of people and communities across the greater Phoenix area.
The Clinical Research Training and Compliance Coordinator is responsible for developing and overseeing a comprehensive training strategy that supports clinical research operations across medical devices, LDTs, and related programs, ensuring alignment with GCP, FDA, ICH, ISO 14155, and other applicable regulations while promoting inspection readiness and operational excellence. In partnership with Clinical Research Leadership, Study Operations, and Quality Assurance, this role designs and maintains role-based curricula for key functions, supports onboarding and ongoing competency development, and drives continuous improvement of learning programs in alignment with evolving regulations, internal policies, and business initiatives.
SUMMARY: Oversees, coordinates, develops, and manages the day-to-day clinical activities for specified research trials in accordance with the research parameters established by the Principal Investigator (PI). The Clinical Research Coordinator I (CRC I) promotes good clinical practices in the conduct of investigations by possessing an in-depth knowledge of federal regulations and guidance documents for the conduct of clinical trials and human subject protection.