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>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.
p>Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol Communication with the medical site staff including coordinators, clinical research physicians, and their site staff Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward Verification that the investigator is enrolling only eligible subjects Regulatory document review Medical device and/or investigational product/drug accountability and inventory Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol Assess the clinical research site's patient recruitment and retention success and offering suggestions for improvement Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance. Must have a minimum of a Bachelor's degree in a health or science related field Experience as a Clinical Research Coordinator (minimum 1 year) Ability to travel 60-70% to locations nationwide is required; some visits may be conducted remotely Must maintain a valid driver's license and the ability to drive to monitoring sites Proficient knowledge of Microsoft Office Strong communication and presentation skills Must be detail-oriented and efficient in time management.
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.
Willing and able to travel up to 60% for on-site monitoring visits across the West region; preference given to candidates residing in West region near major HUB airports to support efficient regional travel. ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
Willing and able to travel up to 50% for on-site monitoring visits across the West region; preference given to candidates residing in Los Angeles, Phoenix, Seattle, Denver or Portland, near major HUB airports to support efficient regional travel. ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
li>Willing and able to travel up to 50% for on-site monitoring visits across the West region; preference given to candidates residing in Los Angeles, Phoenix, Seattle, Denver or Portland, near major HUB airports to support efficient regional travel.
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
What We Are Searching For: Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required. Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirements.
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.
Serves as the primary liaison for internal and external project sponsors, routinely informing key stakeholders of project plans, status updates, milestones (including subject enrollment metrics, timely data collection and submission and related contract and/or grant goals) through regular reporting and coordinated discussions. As our Program Manager of Clinical Research, you will be responsible for the administration, oversight, management, implementation and accountability of clinical research, data collection activities and clinical operations for assigned research program.
Responsibilities : Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol; Communication with the medical site staff including coordinators, clinical research physicians, and their site staff; Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff; Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements; On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward; Verification that the investigator is enrolling only eligible subjects; Regulatory document review; Medical device and/or investigational product/drug accountability and inventory; Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol; Assess the clinical research site’s patient recruitment and retention success and offering suggestions for improvement; and. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective.
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.
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.
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.
Duties include handling key operational functions for research studies and abstracting relevant research related data from medical records and source documents, populating, and coordinating use of research data bases and data sources, participant consenting, screening, enrollment, quality review, training, report production, and submission of collected research data. Our team is uniquely, passionately, and strategically committed to ending Alzheimer''s disease and other neurodegenerative disorders without losing another generation, advancing oncology research to improve cancer prevention and treatment outcomes, and providing an unparalleled model of care for families facing these devastating diseases.
Phoenix, Arizona30+ 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
Scottsdale, AZ30+ days ago
Minimum Education and/or Experience Required: (Education Requirements and Experience): HS Diploma with at least 5 years of clinical research coordination/related experience OR Associate's degree/college Diploma/Certificate Program with at least 3 years of experience, Associate's in Clinical Research from an accredited academic institution without experience OR Bachelor's with at least 1 year of experience or completion of a Mayo Clinic-sponsored clinical research internship in lieu of 1 year of experience. Position Overview: (Major Functions and Non-Essential Functions): Independently coordinates complex (i.e. interventional, therapeutic greater than minimal risk) clinical research protocols with minimal direction from the principal investigator and/or supervisor in compliance with regulatory laws and institutional guidelines.
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;].
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.
p>Minimum Education and/or Experience Required: (Education Requirements and Experience): HS Diploma with at least 5 years of clinical research coordination/related experience OR Associate's degree/college Diploma/Certificate Program with at least 3 years of experience, Associate's in Clinical Research from an accredited academic institution without experience OR Bachelor's with at least 1 year of experience.
Position Overview: (Major Functions and Non-Essential Functions):
Independently coordinates complex (i.e. interventional, therapeutic greater than minimal risk) clinical research protocols with minimal direction from the principal investigator and/or supervisor in compliance with regulatory laws and institutional guidelines.
Phoenix, Arizona30+ days ago
p style="text-align:inherit"/>Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification.
Conduct site facing presentations introducing study opportunities, data sharing and honest broker procedures/workflows, regulatory requirements, clinical trial matching and enrollment services, and system integrations (research and testing).
A typical day includes collecting and reviewing critical regulatory documents to support study start‑up, maintenance, and close‑out, ensuring documents submitted by CRAs are complete, compliant, and filed accurately in CTMS or TMF systems. The Regulatory Associate regularly reviews TMF inventories to identify missing, incomplete, or expiring documents and communicates gaps to study team members.
li>Serving as a regulatory resource, this role supports preparation of regulatory submissions and advises study teams on Good Clinical Practice (GCP), FDA, and applicable regulatory requirements. Castle Biosciences, Inc. is growing, and we are looking to hire a full-time Clinical Research Regulatory Associate working from our Phoenix, AZ office location with a start date of May 15, 2026.
As a Clinical Research Assistant supporting our Cardiometabolic Program, you will be an integral part of the patient's Banner experience looking to provide each person with the best customer service and patient care, you will coordinate scheduling and prepare for research visits, interview and evaluate potential participants to ensure they meet eligibility requirements, instruct participants concerning protocol responsibilities and obtain consent signature, create and file adequate source documentation, accurate and timely data reporting, and perform quality checks. This position is responsible for providing primary support to both investigator-initiated and pharmaceutical research studies and projects by assisting with data collection, documentation, intake/registration, maintenance of source documents, participant recruitment and retention, data entry into research systems, data audits, maintain research supply inventory, and performs administrative tasks and clinical assessments as assigned.
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.
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.
Our team is uniquely, passionately, and strategically committed to ending Alzheimer''s disease and other neurodegenerative disorders without losing another generation, advancing oncology research to improve cancer prevention and treatment outcomes, and providing an unparalleled model of care for families facing these devastating diseases. Acts as a liaison between finance departments, patient financial services, facility research directors and system reimbursement services for the purpose of communicating information regarding the National Coverage Decision for clinical trials and other federal research regulations.
DocTrials was founded with the primary goal of connecting patients and physicians with clinical trials across the US; aiding in the process to discover new therapies, bring hope, and find new treatment for disease. As the project manager of the studies you are assigned as lead, you will learn to execute timely study start-up, develop source documents, and manage monitoring visits.
DocTrials was founded with the primary goal of connecting patients and physicians with clinical trials across the US; aiding in the process to discover new therapies, bring hope, and find new treatment for disease. Patient acquisition: You will be responsible for reviewing patient charts for enrolling trials, creating telephone screening sheets, and conducting recruitment calls.
DocTrials was founded with the primary goal of connecting patients and physicians with clinical trials across the US; aiding in the process to discover new therapies, bring hope, and find new treatment for disease. Patient acquisition: You will be responsible for reviewing patient charts for enrolling trials, creating telephone screening sheets, and conducting recruitment calls.
DocTrials was founded with the primary goal of connecting patients and physicians with clinical trials across the US; aiding in the process to discover new therapies, bring hope, and find new treatment for disease. As the project manager of the studies you are assigned as lead, you will learn to execute timely study start-up, develop source documents, and manage monitoring visits.
DocTrials was founded with the primary goal of connecting patients and physicians with clinical trials across the US; aiding in the process to discover new therapies, bring hope, and find new treatment for disease. Patient acquisition: You will be responsible for reviewing patient charts for enrolling trials, creating telephone screening sheets, and conducting recruitment calls.
DocTrials was founded with the primary goal of connecting patients and physicians with clinical trials across the US; aiding in the process to discover new therapies, bring hope, and find new treatment for disease. As the project manager of the studies you are assigned as lead, you will learn to execute timely study start-up, develop source documents, and manage monitoring visits.
Scottsdale, Arizona11 days ago
The Coordinator-Clinical Research II is the primary contact with the study sponsor and is responsible for the day-to-day management of project activities and resources and overall clinical data and protocol management for the conduct of clinical trials at HonorHealth. May be involved in many of the following activities: recruitment, screening, obtaining informed consent, reviewing source documents, data collection, data entry, query resolution, triggering financial payments, study startup/close out.
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 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.
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.
DocTrials was founded with the primary goal of connecting patients and physicians with clinical trials across the US; aiding in the process to discover new therapies, bring hope, and find new treatment for disease. Communication flow: Collaborate with the recruitment team and site staff to flag barriers to enrollment and suggest improvements to patient outreach efforts.
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.
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.
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>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.
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.
Provides study information and obtains relevant information to and from patients engaged in clinical studies, which includes: • Assisting in the recruitment and screening of volunteers; • Registering patients; • Providing information on clinical trials and protocols to interested participants in a timely and helpful manner; • Obtaining relevant medical history on candidates by phone and in person; • Collecting previous relevant medical records data on patient; • Explaining procedures and consent forms; • Compiling all information prior to the initial visit; • Responding to inquiries from study participants or collateral informants in a timely and helpful manner; • Updating databases with patient information; • Performing other related activities. The department conducts Phases 1-3 treatment clinical trials covering all disease groups with the goal to provide support to the physician investigators and to provide trial treatment options to the patients in a safe and ethical manner, while ensuring compliance to the FDA and institutional regulations.
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.
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.
Scottsdale, AZ30+ days ago
p>If you're an experienced Clinical Research Coordinator who values strong operations, multidisciplinary collaboration, and a schedule that actually supports work-life balance, Headlands Research - Scottsdale may be the right next step in your career. Our Scottsdale site is known for its depth of experience, thoughtful study execution, and team-based approach to clinical research-particularly in vaccines, obesity and weight loss, and CNS trials.