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.
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.
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.
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.
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.
p>With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress.
Certifications/Licenses, Education, and Experience:
- Bachelor's Degree preferred, or equivalent combination of education, training, and experience.
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.
Scheduling subjects for study visits and conducts appointment reminders; Building/updating source as needed; Conducting monitoring visits and resolves issues as needed in a timely manner; Ensuring study related reports and patient results are reviewed by investigator in a timely manner; Filing SAE/Deviation reports to Sponsor and IRB as needed; Documenting and reporting adverse events; Reporting non-compliance to appropriate staff in timely manner; Maintaining positive and effective communication with clients and team members; Always practicing ALCOAC principles with all documentation; May assist with study recruitment, patient enrollment, and tracking as needed; Maintaining confidentiality of patients, customers and company information, and; Performing all other duties as requested or assigned. Responsibilities may include but are not limited to: Screening of patients for study enrollment; Patient consents; Patient follow-up visits; Documenting in source clinic charts; Entering data in EDC and answers queries; Obtaining vital signs and ECGs; May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up; Requesting and tracking medical record requests; Updating and maintaining logs, chart filings; Maintaining & ordering study specific supplies;].
Scottsdale, AZ29 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.
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.
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.
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.
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.
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.
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.
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.
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.
Phoenix, Arizona30+ days ago
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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.
Gilbert, Arizona30+ days ago
About Lighthouse Psychiatry:Lighthouse Psychiatry is a modern outpatient mental health practice delivering evidence-based and interventional psychiatric care, including medication management, TMS, ketamine/esketamine therapy, psychotherapy, and emerging treatment modalities. Our integrative services including psychiatric medication management, counseling, TMS, qEEG, Spravato, ketamine, ADHD testing and treatment, and clinical research of novel treatments.
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.
Phoenix, Arizona22 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.
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.
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 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 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.